Unit competence 06

Establish quality standareds

Introduction
This unit covers the knowledge, skills and attitudes required to establish quality
specifications for work outcomes and work performance. It includes monitoring and
participation in maintaining and improving quality, identifying critical control points in the
production of quality output and assisting in planning and implementing of quality assurance
procedures. Critical Aspect of Competence Include : Monitored quality of work Established
quality specifications for product, Participated in maintaining and improving quality at work,
Identified hazards and critical control points in the production of quality product, Assisted in
planning of quality assurance procedures, Reported problems that affect quality and
Implemented quality assurance procedures
Lastly you will Demonstrates knowledge of: work and product quality specifications, quality
policies and procedures, improving quality at work, hazards and critical points of operation,
obtaining and using information, applying federal and regional legislation within day-today
work activities, accessing and using management systems to keep and maintain accurate
records and requirements for correct preparation and operation

Objectives
 Dear learner! At the end of this session you will be able to:
 Identify market specifications are sourced and legislated requirements identified.
 Develop quality specifications developed and agreed upon
 Document quality specifications to organization staff / personnel in accordance with
the organization policy
 Update quality specifications when necessary
 Identify critical control points impacting on quality.
 Determine degree of risk for each hazard.
 Accomplish necessary documentation in accordance with organization quality
procedures
 Develop procedures for each identified control point to ensure optimum quality.
 Minimize hazards and risks through application of appropriate controls.
 Develop processes to monitor the effectiveness of quality assurance procedures
 Allocate responsibilities for carrying out procedures to staff and contractors.
 Prepare instructions in accordance with the enterprise’s quality assurance program.
 Give staff and contractors’ induction training on the quality assurance policy.
 Give staff and contractors in-service training relevant to their allocated procedures.
 Identify quality requirements
 Inspect inputs to confirm capability to meet quality requirements
 Conduct work to produce required outcomes
 Monitor work processes to confirm quality of output and/or service
 Adjust processes to maintain outputs within specification.
 Monitor work area, materials, processes and product to ensure compliance with
quality requirements
 Identify non-conformance in inputs, process, product and/or service and reported
according to workplace reporting requirements
 Take corrective action within level of responsibility, to maintain quality standards
 Raise quality issues with designated personnel
 recognize potential or existing quality problems.
 identify instances of variation in quality from specifications or work instructions.

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  report variation and potential problems to supervisor/manager according to enterprise
guidelines.

1. Establish quality specifications for product

1.1 Market specifications are sourced and legislated requirements identified.
Sourced
• End-users
• Customers or stakeholders
Legislated requirements
• Verification of product quality as part of consumer legislation or specific legislation related
to product content or composition

1.2 Quality specifications developed and agreed upon

Implementing a quality control program has numerous benefits for your business. By setting
a high standard to work toward, you raise your chances of producing a perfect product and
thus increasing customer satisfaction. Specific guidelines must be set and followed. A vague
goal of merely doing well and trying your best will get you only so far. Having a clear, well-
defined set of standards from the beginning is essential.
Instructions
1. Establish specifically what you want to produce. This goes beyond the vague
hyperbole of a mission statement. Pore over every detail and clearly define what you
want to supply to your customer. Before you can map out an action plan, you need to
define standards for every facet of production.
2. Define each person's responsibility. This includes not only those on the production
level but supervisors as well. It's not enough for them to have a general idea of quality
goals; specifics need to be mapped out and taught. Everyone needs to be working
together, because teamwork is a key ingredient to forming a quality product.
3. Train all workers completely and effectively. Laying out objectives is important, but it
is ultimately useless if workers do not know how to execute them. It will serve you
well not to cut corners on time or money at this stage, because inefficiency and poor
production can cost more in the long run.
4. Maintain your overall focus and keep your eye on the big picture. Details are
important, but it can become all too easy to get bogged down in statistical analysis of
every aspect of production. Commitment to attention to detail is there to serve you,
not the other way around.
5. Observe the competition. Keep an eye on what your successful competitors are doing
and measure your progress against theirs. This is known as benchmarking. Note,
however, that you should ultimately follow your own standards and convictions.
6. Communicate with your suppliers. Take things a step further by ensuring that those
who supply you with your components are also held to high standards of quality.
7. Use feedback to your advantage. By acting on customer and employee feedback, not
only can you correct the errors in production, but your staff can let you know what
does and doesn't work. This will allow you to work together and increase quality.
1.3 Quality specifications are documented and introduced to organization staff / personnel in
accordance with the organization policy
There are different types of specifications, which generally are mostly types of documents,
forms or orders or relates to information in databases. The word Specification merely refers
to the act of "To state explicitly or in detail" or "to be Specific". A specification may refer to
a type of technical standard (the main topic of this page).

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Using the word "specification" without additional information to what kind of specification
you refer to is confusing and considered bad practice within systems engineering.
A Requirement specification is a set of documented requirements to be satisfied by a
material, design, product, or service.[1]
A Functional specification is closely related to the requirement specification and may show
functional block diagrams.
A Design or Product specification describes the features of the solutions for the
Requirement Specification, referring to the designed solution or final produced solution.
Sometimes the term specification is here used in connection with a data sheet (or spec sheet).
This may be confusing. A data sheet describes the technical characteristics of an item or
product as designed and/or produced. It can be published by a manufacturer to help people
choose products or to help use the products. A data sheet is not a technical specification as
described in this article.
A "In-service" or "Maintained as" specification, specifies the conditions of a system or
object after years of operation, including the effects of wear and maintenance (configuration
changes).
Specifications may also refer to technical standards, which may be developed by any of
various kinds of organizations, both public and private. Example organization types include a
corporation, a consortium (a small group of corporations), a trade association (an industry-
wide group of corporations), a national government (including its military, regulatory
agencies, and national laboratories and institutes), a professional association (society), a
purpose-made standards organization such as ISO, or vendor-neutral developed generic
requirements. It is common for one organization to refer to (reference, call out, cite) the
standards of another. Voluntary standards may become mandatory if adopted by a
government or business contract.
1.4 Quality specifications are updated when necessary
Quality data reporting and collection support quality measurement, an important part of the
Shared Savings Program. Before an ACO can share in any savings generated, it must
demonstrate that it met the quality performance standard for that year. There are also
interactions between ACO quality reporting and other CMS initiatives, particularly the
Physician Quality Reporting System (PQRS) and meaningful use. The sections below provide
resources related to the program’s 33 quality measures, which span four quality domains:
Patient / Caregiver Experience, Care Coordination / Patient Safety, Preventive Health, and
At-Risk Population. Of the 33 measures, 7 measures of patient / caregiver experience are
collected via the CAHPS survey, 3 are calculated via claims, 1 is calculated from Medicare
and Medicaid Electronic Health Record (EHR) Incentive Program data, and 22 are collected
via the ACO Group Practice Reporting Option (GPRO) Web Interface.
2. Identify hazards and critical control points
2.1. Critical control points impacting on quality are identified.
Critical control point (CCP) is the point where failure of standard operation procedure
(SOP) could cause harm to customers and to the business, or even loss of the business itself.
It is a point, step or procedure at which controls can be applied and a food safety hazard can
be prevented, eliminated or reduced to acceptable (critical) levels. The most common CCP is
cooking, where food safety managers designate critical limits.
2.2. Degree of risk for each hazard is determined.
After the hazards of concern were identified for Onondaga County, the hazards were ranked
to describetheir probability of occurrence and their impact on population, property (general
building stock includingcritical facilities) and the economy. Each participating City, Town or
Village may have differing degreesof risk exposure and vulnerability compared to the County
as a whole; therefore each City, Town orVillage ranked the degree of risk to each hazard as it

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pertains to their community using the samemethodology as applied to the County-wide
ranking. This assures consistency in the overall ranking ofrisk process. The hazard ranking
for each participating City, Town or Village can be found in theirjurisdictional annex in
Volume II of this Plan.
HAZARD RANKING METHODOLOGY
The methodology used to rank the hazards of concern for Onondaga County is described
below. Estimatesof risk for the County were developed using methodologies promoted by
FEMA’s hazard mitigationplanning guidance and generated by FEMA’s HAZUS-MH risk
assessment tool.
The impact of each hazard is considered in three categories: impact on population, impact on
property(general building stock including critical facilities), and impact on the economy.
Based on documentedhistoric losses and a subjective assessment by the Planning Committee,
an impact rating of high, medium,or low is assigned with a corresponding numeric value for
each hazard of concern.
A hazard analysis is used as the first step in a process used to assess risk. The result of a
hazard analysis is the identification of different type of hazards. A hazard is a potential
condition and exists or not (probability is 1 or 0). It may in single existence or in combination
with other hazards (sometimes called events) and conditions become an actual Functional
Failure or Accident (Mishap). The way this exactly happens in one particular sequence is
called a scenario. This scenario has a probability (between 1 and 0) of occurrence. Often a
system has many potential failure scenarios. It also is assigned a classification, based on the
worst case severity of the end condition. Risk is the combination of probability and severity.
Preliminary risk levels can be provided in the hazard analysis. The validation, more precise
prediction (verification) and acceptance of risk is determined in the Risk assessment
(analysis). The main goal of both is to provide the best selection of means of controlling or
eliminating the risk. The term is used in several engineering specialties, including avionics,
chemical process safety, safety engineering, reliability engineering and food safety.
Hazards and risk
A hazard is defined as a "Condition, event, or circumstance that could lead to or contribute to
an unplanned or undesirable event." Seldom does a single hazard cause an accident or a
functional failure. More often an accident or operational failure occurs as the result of a
sequence of causes. A hazard analysis will consider system state, for example operating
environment, as well as failures or malfunctions.
While in some cases, safety or reliability risk can be eliminated, in most cases a certain
degree of risk must be accepted. In order to quantify expected costs before the fact, the
potential consequences and the probability of occurrence must be considered. Assessment of
risk is made by combining the severity of consequence with the likelihood of occurrence in a
matrix. Risks that fall into the "unacceptable" category (e.g., high severity and high
probability) must be mitigated by some means to reduce the level of safety risk.
Severity Definition
Catastrophic Results in multiple fatalities and/or loss of the system
Reduces the capability of the system or the operator ability to cope with
adverse conditions to the extent that there would be:
 Large reduction in safety margin or functional capability
 Crew physical distress/excessive workload such that operators cannot
Hazardous
be relied upon to perform required tasks accurately or completely
 Serious or fatal injury to small number of occupants of aircraft (except
operators)
 Fatal injury to ground personnel and/or general public

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 Reduces the capability of the system or the operators to cope with adverse
operating conditions to the extent that there would be:
 Significant reduction in safety margin or functional capability
 Significant increase in operator workload
 Conditions impairing operator efficiency or creating significant
Major
discomfort
 Physical distress to occupants of aircraft (except operator) including
injuries
 Major occupational illness and/or major environmental damage, and/or
major property damage
Does not significantly reduce system safety. Actions required by operators are
well within their capabilities. Include:
 Slight reduction in safety margin or functional capabilities
Minor  Slight increase in workload such as routine flight plan changes
 Some physical discomfort to occupants or aircraft (except operators)
 Minor occupational illness and/or minor environmental damage, and/or
minor property damage
No Safety
Has no effect on safety
Effect
Likelihood of occurrence
2.3. Necessary documentation is accomplished in accordance with organization quality
procedures
All documentation utilized within the Company related to the management system itself, or to
the execution of individual customer contracts is controlled to ensure that it is issued to the
appropriate personnel, under the correct level of authority, is revised and reissued as
necessary, and all obsolete versions are removed from the point of use.
Such documentation typically includes:
 Specifications, Customer Orders, Plans/ Drawings,
 Quality Assurance Manual/ Operating Procedures,
 National/ International Standards and Codes of Practice.
The Quality Assurance Manual, Procedures and Quality Plans are maintained by the Quality
Manager who ensures that the appropriate items, at the correct revision levels, are issued to
all who need them within the Company.
National/ International Standards, Codes of Practice are maintained by the Support Engineers
who ensure that appropriate documents are available within the Company, and are issued at
the correct revision levels. External suppliers of documentation are contacted regularly to
ascertain that the documents held remain current.
The distribution of standard documents is controlled and recorded on Distribution Lists,
which also show the current issue status. The Distribution Lists are reviewed and updated as
changes occur.
All changes to documents are reviewed and approved by the person responsible for the
original issue and, where appropriate, the nature of the change is indicated on the document.
Master copies of the revised documents are retained as records of the changes and renewed as
necessary to ensure clarity.
Each contract has a File which contains all relevant information. Information is also held on
the company's computer system for ease of access and manipulation.
3.1 Procedures for each identified control point are developed to ensure optimum quality.
What is a hazard control program?
A hazard control program consists of all steps necessary to protect workers from exposure to
a substance or system, the training and the procedures required to monitor worker exposure

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and their health to hazards such as chemicals, materials or substance, or other types of
hazards such as noise and vibration. A written workplace hazard control program should
outline which methods are being used to control the exposure and how these controls will be
monitored for effectiveness.
How do I know what kind of control is needed?
Selecting an appropriate control is not always easy. It often involves doing a risk assessment
to evaluate and prioritize the hazards and risks. In addition, both "normal" and any potential
or unusual situations must be studied. Each program should be specially designed to suit the
needs of the individual workplace. Hence, no two programs will be exactly alike.
Choosing a control method may involve:
 Evaluating and selecting temporary and permanent controls.
 Implementing temporary measures until permanent (engineering) controls can be put
in place.
 Implementing permanent controls when reasonably practicable.
For example, in the case of a noise hazard, temporary measures might require workers to use
hearing protection. Long term, permanent controls might use engineering methods to remove
or isolate the noise source.
Why should a workplace implement hazard controls?
Some hazards and their controls will be specifically outlined in legislation. In all cases, the
employer has a duty of due diligence and is responsible for 'taking all reasonable precautions,
under the particular circumstances, to prevent injuries or accidents in the workplace'.
In situations where there is not a clear way to control a hazard, or if legislation does not
impose a limit or guideline, you should seek guidance from occupational health professionals
such as an occupational hygienist or safety professional about what is the "best practice" or
"standard practice" when working in that situation.

Remember!
A legal limit or guideline (such as an exposure limit) should never be viewed as a line
between "safe" and "unsafe". The best approach is to always keep exposures or the risk of a
hazard as low as possible.
What are the main ways to control a hazard?
The main ways to control a hazard include:
 Elimination (including substitution): remove the hazard from the workplace, or
substitute (replace) hazardous materials or machines with less hazardous ones.

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  Engineering Controls: includes designs or modifications to plants, equipment,
ventilation systems, and processes that reduce the source of exposure.
 Administrative Controls: controls that alter the way the work is done, including
timing of work, policies and other rules, and work practices such as standards and
operating procedures (including training, housekeeping, and equipment maintenance,
and personal hygiene practices).
 Personal Protective Equipment: equipment worn by individuals to reduce exposure
such as contact with chemicals or exposure to noise.
These methods are also known as the "hierarchy of control" because they should be
considered in the order presented (it is always best to try to eliminate the hazard first, etc).
Where are controls used?
Controls are usually placed:
1. At the source (where the hazard "comes from").
2. Along the path (where the hazard "travels").
3. At the worker.

Control at the source and control along the path are sometimes also known as engineering
controls (see below for more details)
What is meant by elimination?
Elimination is the process of removing the hazard from the workplace. It is the most effective
way to control a risk because the hazard is no longer present. It is the preferred way to control
a hazard and should be used whenever possible.
What is substitution?
Substitution occurs when a new chemical or substance that is less hazardous is used instead
of another chemical. It is sometimes grouped with elimination because, in effect, you are
removing the first substance or hazard from the workplace. The goal, obviously, is to choose
a new chemical that is less hazardous than the original.
The table below provides some examples:
Instead Of: Consider:
carbon tetrachloride (causes liver damage, cancer) 1,1,1-trichloroethane, dichloromethane
benzene (causes cancer) toluene, cyclohexane, ketones
pesticides (causes various effects on body) "natural" pesticides such as pyrethrins
organic solvents (causes various effects on body) water-detergent solutions
leaded glazes, paints, pigments (causes various versions that do not contain lead

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effects on body)
sandstone grinding wheels (causes severe respiratory synthetic grinding wheels such as
illness due to silica) aluminium oxide
Remember, however, that you need to make sure the substitute chemical or substance is not
causing any harmful effects and to control and monitor exposures to make sure that the
replacement chemical or substance is below occupational exposure limits.
Another type of substitution includes using the same chemical but to use it in a different
form. For example, a dry, dusty powder may be a significant inhalation hazard but if this
material can be purchased and used as pellets or crystals, there may be less dust in the air and
therefore less exposure.

Remember!
When substituting, be very careful that one hazard is not being traded for another. Before
deciding to replace a chemical/substance with another, consider all the implications and
potential risks of the new material.
See the OSH Answers document Substitution of Chemicals: Considerations for Selection for
more information.
What are examples of engineering controls?
Engineering controls are methods that are built into the design of a plant, equipment or
process to minimize the hazard. Engineering controls are a very reliable way to control
worker exposures as long as the controls are designed, used and maintained properly. The
basic types of engineering controls are:
 Process control.
 Enclosure and/or isolation of emission source.
 Ventilation.
Process Control
Process control involves changing the way a job activity or process is done to reduce the risk.
Monitoring should be done before and as well as after the change is implemented to make
sure the changes did result in lower exposures.
Examples of process changes include to:
 Use wet methods rather than dry when drilling or grinding. "Wet method" means that
water is sprayed over a dusty surface to keep dust levels down or material is mixed
with water to prevent dust from being created.
 Use an appropriate vacuum or "wet method" instead of dry sweeping (e.g. with a
broom) to control dust and reduce the inhalation hazard.
o Note: Never use a regular "household" vacuum cleaner, especially when
cleaning toxic material such as lead, or asbestos. Use a vacuum specifically
designed for industrial workplaces and be sure to use appropriate filters, etc.
 Use steam cleaning instead of solvent degreasing (but be sure to evaluate the potential
high temperature hazard being introduced such as heat stress).

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  Use electric motors rather than diesel ones to eliminate diesel exhaust emissions.
 Float "balls" on open-surface tanks that contain solvents (e.g. degreasing operations)
to reduce solvent surface area and to lower solvent loss.
 Instead of conventional spray painting, try to dip, paint with a brush, or use
"airless"spray paint methods. These methods will reduce the amount of paint that is
released into the air.
 Decrease the temperature of a process so that less vapour is released.
 Use automation - the less workers have to handle or use the materials, the less
potential there is for exposure.
 Use mechanical transportation rather than manual methods.
Enclosure and Isolation
These methods aim to keep the chemical "in" and the worker "out" (or vice versa).
An enclosure keeps a selected hazard "physically" away from the worker. Enclosed
equipment, for example, is tightly sealed and it is typically only opened for cleaning or
maintenance. Other examples include "glove boxes" (where a chemical is in a ventilated and
enclosed space and the employee works with the material by using gloves that are built in),
abrasive blasting cabinets, or remote control devices. Care must be taken when the enclosure
is opened for maintenance as exposure could occur if adequate precautions are not taken. The
enclosure itself must be well maintained to prevent leaks.
Isolation places the hazardous process "geographically" away from the majority of the
workers. Common isolation techniques are to create a contaminant-free booth either around
the equipment or around the employee workstations.
Ventilation
Ventilation is a method of control that strategically "adds" and "removes" air in the work
environment. Ventilation can remove or dilute an air contaminant if designed properly. Local
exhaust ventilation is very adaptable to almost all chemicals and operations. It removes the
contaminant at the source so it cannot disperse into the work space and it generally uses
lower exhaust rates than general ventilation (general ventilation usually exchanges air in the
entire room).
Local exhaust ventilation is an effective means of controlling hazardous exposures but should
be used when other methods (such as elimination or substitution) are not possible.
A local exhaust ventilation system consists of these basic parts:
1. A hood that captures the contaminants generated in the air (at the source).
2. Ductwork (exhaust stack and/or recirculation duct) that carries the contaminated air to
the air cleaning device, if present or to the fan (away from the source).
3. A fan which draws the air from the hood into the ducts and removes the air from the
workspace. The fan must overcome all the losses due to friction, hood entry, and
fittings in the system while producing the intended flow rate.
4. Air cleaning devices may also be present that can remove contaminants such as dust
(particulates), gases and vapours from the air stream before it is discharged or
exhausted into the environment (outside air), depending on the material(s) being used
in the hood.

The design of a ventilation system is very important and must match the particular process
and chemical or contaminant in use. Expert guidance should be sought. It is a very effective
control measure but only if it is designed, tested, and maintained properly.
Because contaminants are exhausted to the outdoors, you should also check with your local
environment ministry or municipality for any environmental air regulations or bylaws that
may apply in your area.
What are examples of administrative controls?

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Administrative controls limit workers' exposures by scheduling shorter work times in
contaminant areas or by implementing other "rules". These control measures have many
limitations because the hazard itself is not actually removed or reduced. Administrative
controls are not generally favoured because they can be difficult to implement, maintain and
are not a reliable way to reduce exposure. When necessary, methods of administrative control
include:
 Scheduling maintenance and other high exposure operations for times when few
workers are present (such as evenings, weekends).
 Using job-rotation schedules that limit the amount of time an individual worker is
exposed to a substance.
 Using a work-rest schedule that limits the length of time a worker is exposure to a
hazard.
Work Practices
Work practices are also a form of administrative controls. In most workplaces, even if there
are well designed and well maintained engineering controls present, safe work practices are
very important. Some elements of safe work practices include:
 Developing and implementing standard operating procedures.
 Training and education of employees about the operating procedures as well as other
necessary workplace training (including WHMIS).
 Establishing and maintaining good housekeeping programs.
 Keeping equipment well maintained.
 Preparing and training for emergency response for incidents such as spills, fire or
employee injury.
Education and Training
Employee education and training on how to conduct their work safely helps to minimize the
risk of exposure and is a critical element of any complete workplace health and safety
program. Training must cover not only how to do the job safely but it must also ensure that
workers understand the hazards and risks of their job. It must also provide them with
information on how to protect themselves and co-workers.
Good Housekeeping
Good housekeeping is essential to prevent the accumulation of hazardous or toxic materials
(e.g., build-up of dust or contaminant on ledges, or beams), or hazardous conditions (e.g.,
poor stockpiling).
For more information about workplace housekeeping, please see the OSH Answers document
Workplace Housekeeping - Basic Guide.
Combustible Dusts.
Emergency Preparedness
Being prepare for emergencies means making sure that the necessary equipment and supplies
are readily available and that employees know what to do when something unplanned
happens such as a release, spill, fire or injury. These procedures should be written and
employees should have the opportunity to practice their emergency response skills regularly.
Please see the OSH Answers document on emergency planning for more information.
Personal Hygiene Practices and Facilities
Personal hygiene practices are another effective way to reduce the amount of a hazardous
material absorbed, ingested or inhaled by a worker. They are particularly effective if the
contaminant(s) can accumulate on the skin, clothing or hair.
Examples of personal hygiene practices include:
 Washing hands after handling material and before eating, drinking or smoking.
 Avoiding touching lips, nose and eyes with contaminated hands.

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  No smoking, drinking, chewing gum or eating in the work areas - these activities
should be permitted only in a "clean" area.
 Not storing hazardous materials in the same refrigerator as food items.
What should I know about personal protective equipment (PPE) as a hazard control
method?
Personal protective equipment (PPE) includes items such as respirators, protective clothing
such as gloves, face shields, eye protection, and footwear that serve to provide a barrier
between the wearer and the chemical or material.
It is the final item on the list for a very good reason. Personal protective equipment should
never be the only method used to reduce exposure except under very specific circumstances
because PPE may "fail" (stop protecting the worker) with little or no warning. For example:
"breakthrough" can occur with gloves, clothing, and respirator cartridges.
No matter which type of PPE is used, it is essential to have a complete PPE program in place.
For more information about PPE programs, please see the following document Designing an
Effective PPE Program.
Why is it important to monitor and review your hazard control program and methods?
It is important to monitor both the hazard and the control method to make sure that the
control is working effectively and that exposure to the hazard is reduced or eliminated.
Some tools include physical inspection, testing, exposure assessment, observations, injury
and illness tracking, accident/incident investigations reports, employee feedback/input,
occupational health assessment and other methods.
Be sure to answer the following questions:
 Have the controls solved the problem?
 Is the risk posed by the original hazard contained?
 Have any new hazards been created?
 Are new hazards appropriately controlled?
 Are monitoring processes adequate?
 Have workers been adequately informed about the situation?
 Have orientation and training programs been modified to deal with the new situation?
 Are any other measures required?
 Has the effectiveness of hazard controls been documented in your committee
minutes?
 What else can be done?
Adapted from the Occupational Health and Safety Committee Manual prepared by the
Saskatchewan Government.
A review will identify areas that may need more improvement or refinement. It is important
to know if all workplace hazards are identified, assessed and appropriately controlled.
Communication about the hazards and how to control them must be done for all employees of
the organization.

3.2 Hazards and risks are minimized through application of appropriate controls.
Ways to Reduce Fall Hazard Risk
This is key: Once the right risk assessment data is collected, it should be used to implement a
long-term fall protection abatement program.
Despite state-of-the-art equipment and an abundance of fall protection information, fatal falls
still occur every day in our country.
The problem: Fall protection is complex. The numerous regulations, standards, equipment
options, training sources, and other safety priorities make it challenging to address. Plus, fall

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protection presents two conflicting realities: Significant fall incidents don't happen often, but
when they do occur, they're catastrophic and costly.
Managing the major risks presented by falls is a smart and ethical business investment -- in
addition to a legal requirement. But, with all the complexities, how do you effectively reduce
fall hazard risk?

#1: Apply Prevention through Design

The first and best way to reduce fall hazard risk is to eliminate it before it's ever created. This
concept has had various names over the years, but the common name is Prevention through
Design (PtD). With PtD, fall hazards are identified and addressed during the programming
and design phase of new buildings and processes.
Evaluating and implementing safety measures early in a project ensures optimal safety for
workers -- from construction into operations and throughout on-going maintenance. When
safety professionals and front-line employees who know the work best are brought in at the
beginning of a project, safety concerns can be addressed within the project's original timeline
and budget.
Developing a PtD program saves money, time, and effort and creates positive momentum for
a fall protection program. Research studies and project applications have proven that waiting
to address hazards will cost more money while leaving fewer options for abatement.
The impact to bottom-line cost can be dramatic. For example, the consultant fees for one PtD
project would have been spent to erect scaffolding to solve fall protection issues after project
completion -- in one area, one time. Through the life of this project, the scaffolding would
have been erected an additional 20 times, at significant cost and risk to workers. By applying
PtD, the organization achieved a significant order of magnitude cost savings, in addition to
substantial improvements to worker safety and productivity.
4. Implement quality assurance procedures
Implementing Quality Assurance
The Quality Assurance Strategy defines the quality standards for the project and determines
how they are satisfied. Implementation involves carrying out systematic quality activities and
uses quality audits to determine which processes should be used to achieve the project
requirements and to assure they are performed efficiently and effectively.
Project team members, the project manager and the stakeholders are all responsible for the
quality assurance of the project, but the Project Manager will have the greatest impact on the
quality of the project.
The inputs to the quality assurance process are likely to include the following:
 Quality management plan
 Quality metrics
 Process improvement plan
 Work performance information
 Approved change requests
 Quality control measurements
Two of the main tools of quality assurance are quality audits and process analysis.
How to Design and Implement a Basic Quality Assurance Plan
A quality assurance plan should generally include two basic areas: how to address errors
(quality-related events), and how to improve practice before an error occurs (continuous
quality improvement). This document outlines steps to take in establishing a QA plan.
I. Design a means to effectively document quality-related events (QREs) and educate staff
appropriately 1. Collect all relevant details of the event, identify the root cause(s), and make a

12
plan to avoid the same error in the future (consider the example provided on the Board of
Pharmacy’s website)
2. Always educate staff on documented QREs and their resulting plans.
3. Many errors reported to the Board are due to poor customer service in resolving the issue-
consider including training on how to handle an error as part of your plan
II. Identify one or two quality related parameters you would like to measure and improve.
You might consider two categories of parameters:
1. Areas known to require improvement. a. These areas may be identified through a previous
dispensing or procedural error, a deficiency notice from the Board, or observations of
pharmacy staff.
b. Monitoring will be with the intent to track successful improvement.
2. Areas expected to be satisfactory a. These areas may be identified as perceived strengths in
your pharmacy.
b. The intent of monitoring may be to verify that processes are done correctly and to identify
unsuspected weaknesses.
III. Design a method to measure the identified areas. Here are some tips: 1. Focus on
quantitative measures that can show clear results
2. Utilize your computer system’s capabilities where appropriate
3. Use random samples where appropriate (e.g. you don’t necessarily have to go through the
entire prescription log book to quantify counselling documentation)
4. Consider a method that can be accomplished in a reasonable amount of time by appropriate
staff. Keep it simple.
5. Consider a method that can be done consistently as part of normal procedures.
6. Determine how often the measurement will be repeated and make plans to ensure it is not
forgotten.
IV. Set appropriate goals 1. Perfection is not always a realistic goal. Determine what is
acceptable for your practice.
2. Set an attainable goal and be prepared to update the goal when it is achieved.
3. Include instructions on what the person taking the measurement should do if the goal is not
met (e.g. who to contact)
V. Be prepared to make new plans when goals are not met 1. Set a deadline for when unmet
goals will be addressed
2. Be prepared to change policies or procedures in order to improve areas of deficiency
VI. Educate your staff on the Quality Assurance Plan, both at inception and at regular
intervals. Include: 1. Why it is being done
2. What is being tracked
3. How to perform measurements
4. Progress in areas being monitored, including improvements implemented as a result
thereof
5. Updates on any QREs, including the plan to avoid those errors in the future
VII. Quality assurance never ends 1. Continue to update your plan as necessary. Over time,
the entire prescription process can be monitored and improved.
5. Monitor quality of work outcome
Evaluation & Outcome Monitoring
Outcomes Evaluation (Summative Evaluation)
An outcomes evaluation addresses the results of a program. Using varied methods
(qualitative, quantitative, or mixed-methods) data are analysed to determine the impact and
effectiveness of a program and whether or not expected results were achieved. Results of an
outcomes evaluation could be used to determine whether a program is effective short and/or
long term, for certain types of participants only, or for some targeted outcomes but not others.

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Results of the evaluation can be used to assess current practices and areas for improvement,
and where resources are best utilized. Additionally, results contribute to a broader scientific
knowledge base in relation to current theory and practice, and may lead to new insights,
questions, and programs to be tested.
Process Evaluation (Formative Evaluation)
A process evaluation addresses how a project or program is implemented and delivered.
Through varied methods (both quantitative and qualitative), a process evaluation seeks to
understand what, where, when, and how activities occur and whether the project or program
is being delivered as intended (e.g., are target populations being reached and receiving
intended services by qualified personnel?). Because even the most effective programs may
not demonstrate desired results if not implemented as intended, a process evaluation helps
identify issues throughout program implementation which may then suggest and result in
corrective actions. Additionally, results of the evaluation can be examined to understand
factors that may contribute to or hinder project/program success.
5.1 Quality requirements are identified
On an individual requirement by requirement basis, quality requirements are typically much
more important than functional requirements because they most strongly drive thearchitecture
of software-intensive systems. Thus, it is how well the quality requirements are engineered
and implemented that tends to determine the success or failure of mission critical systems.
Yet, missing or poorly specified quality requirements can all too commonly be identified
during effective evaluations of the requirements specifications and the resulting architectures.
This column provides a short checklist for use during the engineering and evaluation of
quality requirements to help the requirements team develop better quality requirements and to
help evaluators of these requirements identify defects in the associated requirements
specifications.
1 THE CRITICALITY OF QUALITY REQUIREMENTS
A great deal of formal and anecdotal evidence exists that the typical quality of actual
requirement specifications today is embarrassingly poor. In practice, far too many
requirements are ambiguous, incomplete, infeasible, unverifiable, inadequately prioritized,
and mutually inconsistent. In fact, this poor quality of individual requirements and the
requirements specifications that document them is a primary reason why so many projects
continue to fail [Standish 1994]. Because so many requirements defects remain in
requirements specifications after they have been reviewed and approved, clearly the current
approaches as applied in practice being used to develop and review requirements are
seriously inadequate to discover and correct these defects.
Unfortunately, the poor quality of the requirements is typically not recognized during
requirements engineering and the evaluation of requirements specifications. Due to
inadequate customer organization (e.g., the Government or commercial market) experience,
training and tool support, the stakeholder (e.g., business, user) requirements typically contain
large numbers of defects. These requirements may be internally reviewed, but most defects
are not found. These stakeholder requirements are then passed on to the development
organization (e.g., prime contractor or internal IT), which derives system-level technical
requirements. For similar reasons, these technical requirements are typically of poor quality,
and a great many defects are not identified when the requirements specifications are duly
evaluated during peer-level and more formal milestone reviews. This process continues down
the system logical architecture from system to subsystems to sub subsystems and from prime
contractors to subcontractors and integrated product teams (IPTs) who are responsible for
implementing the allocated requirements. Although many defects are identified and fixed
during this process of derivation and evaluation, a vast number of requirements errors still

14
slip through the requirements engineering process into the architecture, design, and
implementation.
While this passing on of requirements defects is true of all types of requirements, it is
especially true of quality requirements. Unfortunately, quality requirements are the primary
drivers of the system and subsystem architectures. Only when it becomes time to technically
evaluate these architectures does the dismal quality of the quality requirements become
obvious. Because quality requirements are the primary drivers of the architecture, an effective
architecture assessment must evaluate the architecture against its support (or lack of support)
for these architecturally-significant drivers.
Because the requirements specifications tend to be extremely week when it comes to properly
specifying quality requirements, the assessors of the architecture often find that they cannot
properly evaluate the architecture because they do not have adequate requirements against
which to assess it. In fact, because assessors of the architecture are so used to dealing with
requirements specifications that do not contain adequate architecturally-significant quality
requirements; they have been forced out of self-defenceto take on some of the responsibilities
of the requirements team. They have been forced to develop architectural assessment
methods that begin with some kind of identification and derivation of these quality
requirements.
Structure of Quality Requirements
As documented in figure 1, a quality model defines the meaning of quality for a system.
The quality requirements of a system are related to the quality model that is used to define the
meaning of quality for that system. Specifically, each quality requirement specifies that the
system under development shall achieve a minimum amount of some quality factor or sub
factor defined by the quality model. This common purpose and relationship to quality models
imply that no matter what quality factors they address, all quality requirements should have
roughly the same structure and contents.
• Quality Criterion. The heart of each quality requirement is a quality criterion that
mandates that the system shall exhibit a single aspect of quality of the system.
The actual criterion is system-specific, but it describes a general type of quality as defined in
the associated quality model.
• Condition(s). Each quality requirement should typically also include an appropriate set of
one or more conditions that specify under which circumstances the quality criterion shall
hold. Usually if the conditions are not explicitly listed, the quality criterion is interpreted to
apply under all conditions. However, the quality criterion may not be appropriate during
system start-up, system-shutdown, or during degraded modes of operation. Perhaps the
criterion is only appropriatedduring certain normal modes of operation such as aircraft
taxiing, take off, climbing, cruising, decent, landing. A great many quality requirements are
incomplete because they lack appropriate conditions.
• Threshold. All quality requirements are scalar in that they require a specific minimum
amount of some quality factor. Quality requirements therefore should include a required
threshold on some appropriate scale of measurement. Without the threshold, the requirement
does not specify how much quality is good enough and therefore tends to be an unfeasible
goal rather than a true requirement.
• Quality Criterion. Does each quality requirement include a well-defined, cohesive,
system-specific quality criterion that adequately describes a single required aspect of the
system in terms of an appropriate quality factor or one of its quality sub factors?
• Goals as Requirements. Is each quality requirement more than merely a statement that the
system shall have the property of the quality factor or sub factor? For example, “The system
shall be safe.” Such statements are infeasible goals rather than verifiable requirements.

15
• Scale with Threshold. Is each quality requirement scalar in the sense that it has an
associated mandatory threshold that specifies exactly how much of the quality factor or sub
factor is necessary? Is the threshold well defined in terms of an associated scale of
measurement? Is the scale of measurement appropriate for the quality criterion?
• Conditions. Does each quality requirement include one or more conditions that describe
when the quality criterion must hold? If a quality criterion does not have any associated
condition, must the quality criterion hold under all conditions (e.g., system start up, system
shutdown, degraded mode)? Have all system modes and states been considered when
determining the scope of applicability of the quality requirement?
5.2 Inputs are inspected to confirm capability to meet quality requirements
Capability management aims to balance economy in meeting current operational
requirements, with the sustainable use of current capabilities, and the development of future
capabilities, to meet the sometimes competing strategic and current operational objectives of
an enterprise. Accordingly, effective capability management:
 Assists organisations to better understand, and effectively integrate the total enterprise
ability or capacity to achieve strategic and current operational objectives; and
 Develops and provides solutions that focus on the management of the interlinking
functions and activities in the enterprise's strategic and current operational contexts.
In military contexts, capabilities may also be analysed in terms of Force Structure and the
Preparedness of elements or groupings within that Force Structure. Preparedness in turn may
be analysed in terms of Readiness and Sustainability.
In both the military and commercial contexts, net-centric operations and related concepts are
playing an increasingly important role in leading and driving business transformation, and
contemporary capability management needs to have close regard of those factors. The level
of interoperability, both technical and organisational/social, is a critical determinant of the
net-centric capability that is able to be realised and employed.
Enterprises consist of a portfolio or matrix of capabilities that are used in various
combinations to achieve outcomes. Within that portfolio, a capability will be transient unless
managed and maintained over time. Therefore, a typical capability lifecycle spans needs,
requirements, acquisition, in-service and obsolescence/disposal phases.
While a highly developed management discipline within several national military
organisations, the concepts, principles and practices of capability management are readily
adaptable and effective for wide-ranging application in the strategy and operations of many
other enterprises.
 e approaches to implement the capability.

Capabilities Described with Architectures.

Capabilities are organized around concepts of operations (CONOPS), because the CONOPS
describe how a specified course of action is to be executed. The ability to execute the
specified course of action depends on many factors and the relationship between those
factors. Capabilities can be described as one or more sequences of activities, referred to as
operational threads. The threads are composed of a set of activities that can be grouped to
form the basis for mission area architecture. The architecture then provides the structure for
defining and understanding the many factors that impact the capability. The figure illustrates
this sequence of relationships.
The Navy has also endorsed using architectures to understand and analyze capabilities and
their associated requirements. The Navy performs this architecture analysis based on the
concept of MCPs. The intent is to consider all of the factors that contribute to the desired
mission capability as an integrated system. An MCP is defined as “a task-oriented bundle of
CONOPS, processes, and organization structures supported by networks, sensors, weapons,

16
and systems, as well as personnel training and support services to sustain a core naval
capability.” The MCP and associated analysis then provide the basis for acquisition decisions.
Capability management considerations
Due to the complexities of system-of-systems integration, interoperability, and the dynamic
nature of operations, capability management is greatly assisted by modelling and simulating
realistic strategic scenarios and contexts, in order to inform business cases and decision-
making. Through those considerations and practices, the enterprise and its performance can
be continuously assessed and projected into the future. Well executed capability management
therefore clearly informs strategic and operational decisions, and aids in the development of
diverse but well-considered strategic and operational options, so they are readily available
off-the-shelf. This should also endow significant agility to an enterprise, providing enhanced
"contingency capital" and risk mitigation.
Capability management therefore centres on:
 Strategic and operational appreciations and analyses
 Capability conceptualization, definition and development
 Operations research and analysis
 Context or scenario-based capability modelling and simulation
 Capability costing
 Capital project business cases and management
 Decision making and decision support
 Capability assurance and performance management
Deliverable: Quality Requirements
Defines the customer's expectations for quality, the internal process and product attributes
that indicate whether the quality factors are being satisfied, and the measures to be used to
give visibility to the levels of quality being achieved.
The quality requirements are defined in terms of:
Quality Factors
The quality factors document the user-perceived aspects of the end products of the project
that will determine whether the project meets the customer's expectations.
Quality Criteria
The quality criteria document the internal process and product attributes that will be
monitored throughout the project to indicate whether the quality factors are being satisfied.
Quality Metrics
The quality metrics document the indicators to be used to measure service and product
quality.

5.3 Work is conducted to produce required outcomes

A true professional is willing to help his or her co-workers when they are overburdened. 
Professionalism is defined as one's conduct at work. In spite of the word's root, this quality is
not restricted to those in occupations we describe as "professions," typically those which
require a high level of education and have high earnings. Cashiers, janitors and waitresses can
demonstrate a high level of this trait, just as doctors, lawyers or engineers can display a low
level of it, and vice versa.
As with good health, the absence of professionalism is usually more obvious than its
presence. Who will notice whether you have this quality or not? Your boss definitely will as
will your customers and co-workers, and it can affect your ability to keep your job and
advance in your career. So what can you do to make sure you exhibit professionalism and
what can you do to ensure that you don't show a lack of it?
Follow these dos and don'ts:

17
Make Being on Time a Priority: Showing up late for work or meetings gives the impression
that you don't care about your job so make sure you pay attention to the clock. Not only does
this go for start times, but this tip also applies to returning from your lunch break.
Don't Be a Grump: Leave your bad mood at the door when you come to work. We all have
days when we aren't feeling our best. Remember not to take it out on your boss, your co-
workers and especially your customers. If work is what's causing you to be grumpy, it may be
time to think about quitting your job. If that isn't a good option for you, make the best of the
situation until it is.
Dress Appropriately: For many jobs, workplace attiredoesn't include wearing a suit and tie.
Whether or not you have to dress up for work or you can wear more casual clothes, your
appearance should always be neat and clean. A wrinkled suit looks no better than a ripped
pair of jeans. Wear the type of clothing your employer requires or that is the norm for your
place of employment. Generally speaking, revealing clothing is a no-no.
Flip flops, shorts and tank tops should be saved for the weekends.
Watch Your Mouth: Swearing, cursing or cussing—whatever you call it—has no place at
work, particularly if those who might be offended by it are present. If you wouldn't say it to
your grandmother, refrain from saying it at work. Using bad language makes it seem as if
your vocabulary is limited.
Offer to Help Colleagues: A true professional is willing to help his or her co-workers when
they are overburdened. He or she isn't afraid to share knowledge, opinion or simply an extra
pair of hands. One person's success reflects well on everyone in his or her workplace.
Don't Gossip: While you may be tempted to tell your cubicle neighbours what you heard
about Suzy or Sam down in accounting, gossiping makes you look like a middle school
student. If you know something that simply must be shared, tell someone who has nothing to
do with your workplace, like your sister, brother or best friend.
Try to Stay Positive:Negativity at work brings everyone down and your boss will certainly
not appreciate a drop in morale among his or her employees. Instead, if you think something
can be improved, try to do something to make that happen.
Don't Hide From Your Mistakes: As hard as it may be, take ownership of your errors and
do your best to correct them and make sure you don't make the same one twice. Never blame
others, but set an example for those who were also responsible to do as you've done.
Always Fight Fair: It is inevitable that you will occasionally have disagreements with your
co-workers, or even your boss. You may think that something should be done one way, while
someone else will believe it should be done another. Don't let yourself lose control. No matter
how upset you are or how strongly you believe you are right, screaming isn't allowed, nor is
name calling or door slamming. And, it should go without saying that physical attacks should
always be avoided, no matter what. Calmly explain your opinion and be ready to walk away
if the other person can't be swayed or if he or she begins to lose control.
Don't Lie: Dishonestly never makes anyone look good, whether it's lying on one's resume or
calling in sick. A true professional is upfront, so if you aren't qualified for the job either
doesn’t apply for it or send in your application anyway and explain why you'd be perfect for
the job in spite of it. As for lying about being sick, if you need a day off take a personal or
vacation day.
Don't Air Your Dirty Laundry: While confiding in a close friend at work is usually okay,
sharing too much information with the entire office isn't. Be judicious about whom you talk
to, particularly when it comes to discussing problems with your spouse or other family
members. If you do decide to share personal information with your co-workers, make sure to
do it away from where customers and clients can overhear you.
Code of Conduct in a Workplace

18
A code of conduct for salespeople typically covers honesty, client relationships and
confidentiality.
An organizational workplace code of conduct establishes acceptable standards of behaviour
for all employees. Some departments also have codes specific to employees working in areas
such as human resources, sales and service. The code of conduct is intended to serve as an
internal communication tool as well as a device to protect the company in cases where it must
terminate an employee for cause.
5 4 Work processes are monitored to confirm quality of output and/or service
Work must be carried out in compliance with the regulations and workplace requirements
pertaining to the security procedures in the workplace.
Work is performed under some supervision, generally within a team environment.
Work involves the application of workplace procedures and regulatory requirements to
security operations as part of work activities in the postal, warehousing, stevedoring,
transport, distribution and allied industries.
5.5 Processes are adjusted to maintain outputs within specification.
WHO DEVELOPS THE OUTPUT SPECIFICATION?
. The output specification is the local authority’s main mechanism for defining its
requirements: it owns the specification and leads on its development.
The local authority’s project team will need a range of skills and knowledge of matters such
as strategic policies and planning, school specific issues, design, building and maintenance,
legal issues such as land, procurement and contracts, and financial issues such as modelling,
taxation and budget management. Some of this expertise may be provided by internal or
external advisors assisting the core team.
WHEN IS THE OUTPUT SPECIFICATION DEVELOPED?
The output specification is first issued to bidders as part of the invitation tonegotiate (ITN)
documentation, but its format and content needs to be developed by the project team from the
outset of the project. This should happen as soon as the local authority’s outline business case
has received final approval and the procurement phase begins.
An outline draft of the output specification may be issued to potential bidders at
prequalification stage of the procurement. This can provide an early structure and focus for
more detailed work and send a clear signal about the local authority’s commitment and
approach to the project.
The project timetable should allow a realistic period for the output specification to be
developed fully, including appropriate consultation with stakeholders.
6. Participate in maintaining and improving quality at work
6.1 Work area, materials, processes and product are routinely monitored to ensure
compliance with quality requirements
How to Improve Productivity & Quality

Improve productivity to achieve better company performance.

Improving productivity and quality in your business typically results in increased customer
and employee satisfaction. Using quality management system techniques such as process
mapping, benchmarking and cost-benefit analysis, you can achieve regular improvement in
all your work-flow processes. Improved productivity results in fewer defects, fewer delays
and reduced costs.
Step 1
Analyse your processes. Focus not on the people performing the job but on the tasks they do.
Standardize policies and procedures through your company to maximize efficiency. Train all
personnel adequately so they can produce high-quality products and take pride in their work.
Step 2

19
Align your business processes with other companies in your industry. The American
Productivity and Quality Centre website provides tools, including the Process Classification
Framework, to help you improve your company’s business performance.
Step 3
Develop performance measurements. Benchmark your current processes, identify problems,
predict future outcomes and measure productivity gains using key performance indicators for
your industry. For example, measure quality and productivity in your customer support centre
by measuring the time it takes to resolve customer issues and the customer satisfaction rate
for those support cases.
Step 4
Build quality testing into your processes -- not at the end when it is more expensive to fix.
Perform testing on an iterative basis. Resolve defective component problems as you
encounter them without waiting for the entire testing cycle to complete. Implement
automated testing if possible, because it executes without human intervention and results in a
pass or fail outcome that is easy to interpret and act upon.
Step 5
Use business strategies such as Six Sigma to improve quality and productivity. Create
projects that define a problem, measure the current process, gather relevant data and analyse
the data to validate the cause-and-effect relations. Determine the root cause of issues and
design interventions to improve or optimize the processes. Control production so that defects
get corrected early on before they impact your final product.
Step 6
Value employee, customer, supplier and business partner feedback and input regarding
solving product or service problems. Measure quality and productivity gains by increases in
customer satisfaction. Use customer feedback to improve current products and influence the
design of new ones. Leveraging customer requirements in your process redesign efforts can
help you focus your efforts on the most lucrative areas of business in your industry. For
example, conduct surveys or focus groups to gather information to resolve top issues with
your product or service. Prepare a report summarizing findings, and distribute the report
throughout your organization to improve quality and productivity.
5 Ways to Improve Your Employee’s Quality of Work & Life

Having fun at work and improving quality of life has long been tied to improved employee
engagement and productivity as well as employee retention.  Recent studies show that fun at
work also lowers employee healthcare and increases an employee’s overall quality of life.
Research shows that the happiest employees take 66% less sick leave and that the happiest of
people at work are good for teams and can boost the mood of colleagues.

20
Increasing Your Employee’s Quality of Life at Work
Having a work environment that promotes wellness and happiness not only increases mood,
but productivity.  The same study reported that happy workers reported spending 80% of
their week on work related tasks, while less happy workers spend only 40% of their time on
work related tasks.  What boss doesn’t want employees spending more time on work related
tasks?   The idea of having fun at work isn’t new. What is important is addressing the direct
connection to an employee’s quality of work and life and their work performance without
dramatically impacting your company or department’s bottom line. .
 Manage your workforce, but avoid micromanaging. No one likes their employer
looking over their shoulder every minute of every day. More than ever there is a large
pool of employees who don’t need managing. Self-starters are in abundance and work
a whole lot better without a micromanager. Employees need to be given freedom to
think for themselves and work in a space that isn’t constrained at every turn. In order
to produce exceptional results, quit micromanaging.
 Recognize good work. How can something so simple improve quality of work? As
GenY starts to become one of the largest demographics in the workforce they rely on
constant recognition. You must ensure that as an employer you always have
something positive to say about your employees and their work. Don’t rely on the old
principle if you don’t say anything that means everything is fine, because GenY will
take that as things being worse. Rewards, and other ways of keeping employees happy
will make them feel that their effort is being recognized and that the company needs
them.
 Set goals, reward if met. Have production goals that need to be met by the end of the
day? Set a goal and does something fun if the goal is met. Giving your employees a
challenge throughout the day will give them something to work towards and generally
they will go above and beyond to meet the goal. For example, focus on production
goals or deadlines that have to be met. If they meet them ahead of schedule, go out for
happy hour on the company, extend their lunches, or if viable, let them take half a
day. These simple rewards will revitalize your employees and give them more drive to
produce the same results outside a rewards system.
 Challenge your employees. To go one step further on setting and meeting goals,
challenge your employees with new tasks that might be outside their job function. Do
you have a problem within your organization that needs fixing? Challenge an
employee to head a taskforce or committee to identify, evaluate, and come up with a
solution. Making employees feel like they are apart of a bigger change will encourage
them and keep the quality of their productivity up.
 Food is fun.Food can be a powerful short term motivator for your workplace. Don’t
give them food in exchange for having to listen to their boss go on and on about work,
no one will stay and you’re basically using lunch to sell your employees. Free lunches
boost workplace morale and wellness (depending on what you provide for them).
Providing free food doesn’t only increase morale, but it makes employees appreciate a
company a little more. Free food has this magic quality that instantly gives your
company credibility with employees.
6.2 Non-conformance in inputs, process, product and/or service is identified and reported
according to workplace reporting requirements
Investigating Non-Conformances
As a food auditor an important part of the job is identifying non-conformances during the
audit process. Unfortunately, many food businesses struggle with what is required to rectify
non-conformances. Any non-conformance identified during an external or internal audit

21
should be seen as an opportunity to really get in and resolve an issue before it escalates to a
point where significant damage can occur to the business.
After an issue or non-conformance has been identified the business should not only seek to
rectify the issue immediately but to also investigate the root cause of the problem. This means
really finding out why the problem occurred in the first place. There are plenty of different
models out there for investigating the cause of non-conformances including Brainstorming,
Root cause analysis, The 5 Whys and Cause & Effect Diagrams.
I really like the 5 Whys model as it reminds me of my kids when they constantly question
why they are not allowed to do something.
The following example shows how the method can be used in a food manufacturing business:
Non-conformance: No paper towel at wash hand basin
Q: Why is there no paper towel supplied to the wash hand basin?
A: Cleaner did not refill
Q: Why did the cleaner not refill?
A: Could not locate any stock
Q: Why was there no stock?
A: Stock had not been ordered
Q: Why had the stock not been ordered?
A: The purchasing officer was not informed that stock was low.
Q: Why were purchasing not informed?
A: The cleaner didn’t know who to tell.
Q: Why didn’t the cleaner know who to tell?
A: They have not been adequately trained in the procedure
As you can see, your questions may not always be limited to “5 Whys” – it could be more or
it could be less. The Band-Aid solution in this case would be to just refill the paper towel
dispenser.
Does your business apply the “Band-Aid” to non-conformances or investigate the root cause?
If you continually receive the same types of customer complaints or the same issues are being
identified for example at each GMP audit that you do, you are most likely not doing anything
or just using a Band-Aid solution.
I challenge you to now have a look at your last GMP inspection that you did and see if:
(1) All the issues that you identified have been rectified
(2) The root cause has been investigated and documented
(3) Suitable controls have been put into place to prevent a re-occurrence of the non-
conformance.
For more information on any of the models used to investigate non-conformances just do a
search using your internet search tool.
Want to learn more about investigating and rectifying non-conformances? Show your interest
by contacting us or leaving a comment.
1 Identifying areas of non-compliance
BS EN ISO 14004 identifies nonconformity as non-fulfilment of a requirement in relation to
the management system or in terms of environmental performance. Nonconformities could be
due to either system performance or environmental performance. System performance
nonconformities might include a failure to establish the environmental objectives or targets
while performance nonconformities might include not achieving operating criteria (for
example waste or emissions targets).
Environmental Management Systems (EMSs)
There are a wide variety of operational tools and systems available to an environmental
officer to help him or her monitor and ensure compliance. A structured system which
monitors and manages the environmental impacts of an organisation’s activities is referred to

22
as an Environmental Management System or EMS. As well as overseeing any environmental
impacts, an EMS should also help in the planning, organisation and review of the
environmental performance of a company’s activities. An EMS does not have to be managed
solely by one individual in an organisation; often it will be the joint responsibility of a
number of people, including at least one person at senior director level. There is a wide range
of assistance and guidance available on management and implementation of an EMS from a
variety of external sources. Key term EMS – Environmental Management System – a
structured system which monitors and manages the environmental impacts of an
organisation’s activities.
Many of the environmental regulations looked at in Topic guide 1.1 require an EMS to be in
place in order to gain a permit to carry out activities which may have an environmental
impact.
An effective EMS should: be implemented at a strategic level and integrated into corporate
plans and policies, thus indicating senior-level commitment and ensuring senior management
understand their role in ensuring the success of an EMS identify the organisation’s impacts
on the environment and set clear objectives and targets to improve management of these
environmental impacts and the organisation’s overall environmental performance be designed
to deliver and manage compliance with environmental laws and regulations on an on-going
basis, and will quickly identify any areas of non-compliance and instigate corrective and
preventative action in such cases
 allow for efficient resource management and provide financial benefits
 incorporate approved performance benchmarks that demonstrate the above
 Provide for recording and communication in a transparent manner in reports.
External agencies provide certification of internal EMSs and in turn they are accredited by
the relevant International Standards Organization.
As compliance is measured by checking actual operations and procedures against legal and
regulatory requirements, as well as internal targets, organisations are often unaware of when
exactly they may be in non-compliance with regard to legal and regulatory requirements due
to the changing nature of these benchmarks. Some areas of legal compliance are subject to
frequent amendments and updates, with changes in regulation often following.
In manufacturing, engineering, construction and building services engineering, likely areas of
non-compliance would include energy and fuel use, waste products, transportation and
environmental impacts of activities.
Local authority monitoring of construction work compliance
Every local authority has a well-established system of monitoring and ensuring compliance
with the building regulations. This is referred to as ‘building control’ and monitoring takes
place through local authority appointed building inspectors who visit and inspect building
work as it proceeds. Construction work which does not comply with environmental or other
standards such as structural safety will not be approved and the completed building may
ultimately be unsalable if it does not have a ‘completion certificate’ verifying that
construction has met the building regulations standards. Non-compliance is avoided by
submitting plans and structural information to the building control department in advance and
incorporating advice from the building control officers before and during works.
Role of the HSE in identifying non-compliance
The Health and Safety Executive (HSE) is the enforcing body for health and safety
legislation and regulations in the UK. The HSE has a mandate to inspect any workplace,
including building sites, and it is one of the responsibilities of the contractor to inform the
HSE that work is taking place at a particular address prior to the commencement of the
project. The HSE will inspect any site and provide advice on areas of non-compliance. If

23
there are serious breaches of compliance, or if the site is deemed to be unsafe, then the HSE
has the power to close the site until compliance is met.
General reasons for non-compliance
Assuming that there is an EMS in place and the review stage of the EMS has highlighted
areas of non-compliance, general reasons for non-compliance may include:
 shortcomings in the EMS
 changing business circumstances
 changing economic situation/priorities
 changing operating procedures
 operations in new countries or regions
 new laws or regulations
 industrial action
 health and safety breach – accidents
 natural causes such as unpredictable weather or storms
 Poor initial target setting.

Root causes of non-compliance

A study into environmental non-compliance by the United States Environmental Protection
Agency found that the vast majority of non-compliance events were due to multiple reasons,
the root causes being:
 operator unaware of where a regulation applies
 human error
 operating procedure not followed
 equipment design or installation problem
 procedure not followed by contracted services such as sub-contractors, suppliers and
handlers
 Poor communication between operator and regulatory agencies.
 In addition, a number of contributory factors have been identified, including:
 management failure to identify environmental compliance aspects of processes and
operations
 poor reporting or notification procedures
 contradictory interpretation of regulations
 Insufficient audit programme and routine site and equipment checks.

After identifying areas of, and finding reasons for, non-compliance, the EMS must be
amended to ensure similar breaches do not happen again. This is a natural part of the
development cycle of an EMS and a new system may have a steep improvement curve when
it is first put into place. Reasons for non-compliance must be examined and their root cause
identified and classified according to whether capital, operating or training-based
improvement is required (see the next section). Any contributory factors similar to those
outlined above must also be considered and appropriate amendments made to procedures.
6.3 Corrective action is taken within level of responsibility, to maintain quality standards
Having identified the areas of, and examined the reasons for, non-compliance, the
organisation needs to make recommendations for improvement. This can take place during a
management review of an EMS; this review would take place within the ‘act’ phase of the
‘plan-do-check-act’ system, as set out in ISO 14000.10
Root causes of non-compliance Recommendation for solutions 1 Operator unaware of
where a regulation applies Education and training 2 Human error Education and training 3

24
Operating procedure not followed Education and training 4 Equipment design or installation
problem Capital investment 5 Procedure not followed by contracted services such as sub-
contractors, suppliers and handlers Improved communication procedures 6 Poor
communication between operator and regulatory agencies Improved communication
procedures
Opportunities for improvement to the EMS
ISO 14004 recommends periodic review of the EMS to ensure that non-compliance does not
occur due to a poor EMS. The standard recommends sources of information to aid
improvement of the EMS. These are:
experience gained from corrective and preventive actions
external benchmarking against best practices
intended or proposed changes applicable to legal requirements and other requirements to
which the organisation subscribes
 results of environmental management system and compliance audits
 results of monitoring of key characteristics of operations
 results of progress towards achieving objectives and targets
 views of interested parties, including employees, customers and suppliers.
ISO 14004 also provides basic practical advice on improving the EMS by:
 establishing a process for evaluating new materials to promote the use of less harmful
materials
 improving an organisation’s process for identifying applicable legal requirements so
that new compliance requirements are identified in a more timely fashion
 improving employee training on materials and handling to reduce an organisation’s
generation of waste and/or introducing waste water treatment processes to allow water reuse
 implementing changes in default settings on reproduction equipment to print two-
sided copies at a printing office
 Redesigning delivery routes to reduce fossil fuel consumption by transportation
companies, and setting objectives and targets to implement fuel substitution in boiler
operations and reduce particulate emissions.
6.4 Quality issues are raised with designated personnel
Ways to Improve Quality
Whether you sell a product or a service, these five steps will help you ensure that you are
constantly improving the way you do business--to the delight of your customers.
Every business owner likes to think that he or she has a commitment to quality. If that were
truly the case, of course, no product would ever disappoint, and no service would result in a
complaint. So how can you improve quality at your company? Here are 5 steps you can take
to put you on the right path
1. Make a commitment.  
 W. Edwards Deming, the father of the quality movement, famously laid out 14 points for
management—chief among them, the notion of "constancy of purpose." Deming argued that
a company's commitment to quality had to come from the top, and it had to be reinforced
over and over again. Unless a business views quality as its single, non-negotiable goal,
workers will inevitably feel the need to make trade-offs and quality will slip.
"Constancy of purpose means that quality decisions are not situational," writes the
operational expert Rebecca A. Morgan. "End of month quality is the same as beginning of
month. It means that the long term benefit of the organization is not sacrificed to hit quarterly
targets."
So are you ready to commit? If you are, you should tell your staff—and then think about how
you will handle the first conflict between your stated objective and a pressing deadline or an
attractive short cut.

25
Track mistakes.
If you are going to commit to quality, first you must define exactly what quality is. For
manufacturers, this process involves statistical quality control, the process of setting a
product's specifications and then sampling a small number of units from the production line
to see how closely they measure up to those specs. Standards are set and, if too much
deviation occurs (or if quality appears to be trending in the wrong direction), the
manufacturing process is altered.
Tracking quality is admittedly more difficult in a service business, and efforts by groups such
as the International Organization for Standardization (known as ISO) to create meaningful
benchmarks beyond manufacturing have had mixed results.
.
3 Invest in training.
An old saw of the quality movement is that any business with a quality control department is
doomed to poor performance, for it has demonstrated to every other employee that quality is
not his or her chief concern. Instead, quality experts recommend that businesses train workers
at all levels to look for ways to improve quality and to ameliorate problems.Whether you
hand train duties to your employees, take them on personally, or some combination of the
two approaches, it's important that you provide workers with a history of the company
through the lens of quality. Let them know what problems you have had in the past, how you
corrected these problems, and where your company stands with respect to its quality goals
today. You should also go over your definition of quality in detail, and show them how you
measure quality (see the previous section.) Finally, train workers to see the connection
between their actions and, more broadly, their work ethic, and the company's overall
performance. By tying individual behaviour to an overall system of work, and then showing
where that system can, on occasion break down, you will be giving workers the information
they need to be good stewards of your business.
Organize quality circles.
Your staff members may roll their eyes at the introduction of such a dated technique, but
organizing employees into quality circles can be an effective way to identify and address
problems. Simply put, quality circles are groups of employees who are encouraged to assess
processes and recommend improvements, all with the goal of promoting quality, efficiency,
and productivity. The concept was developed by Deming in post-war Japan, and made its
way to the United States in the late 1970s. At one point, half of all large corporations had
adopted quality circles, but then interest in them faded.That's a shame. Quality circles, by any
other name, are teams of workers who are given the authority and responsibility for making a
business better. To succeed, experts say that participation in a quality circle should be
voluntary; circles should draw members from all corners of a company; and the circle should
set its own agenda (rather than pursuing a company owner's agenda.)
Once you have invited workers to join a quality circle, provide them with adequate resources
to pursue their analysis, and schedule a time in the future at which they may present their
findings. It is important that you act on their recommendations, even if the group's conclusion
is not necessarily one you would have drawn yourself. Remember, the purpose of the exercise
is less to solve a particular problem than it is to engage workers in the process of finding and
addressing concerns. Moreover, you should be tracking customer complaints or product
defects on a regular basis, so if the circle's recommendations do not produce the desired
result, you'll know it, and be able to act.
Have the right attitude.
Too many people turn the quest to improve quality into something oppressive. No less an
authority than Deming rejected the idea that the quality management had to be dreary and

26
involve a lot of negativity. "The prevailing system of management has crushed fun out of the
workplace," Deming moaned in an interview in the 1990s.
This attitude is not necessarily easy to adopt and runs afoul of some of the basic management
practices we take for granted. For example, Deming was not a fan of performance reviews, as
the writer John Case has explained. "If your evaluations are fair, you will determine that half
your workers (by definition) are below average, and you will tell them so," Case writes.
"Result: half the work force is instantly discouraged and demoralized, and any sense of
common purpose is undermined."
Rather than pointing out inadequacy wherever it might be found, Deming believe that the job
of managers was to frame the pursuit of quality as an interesting, noble, and worthwhile goal.
If you are to truly improve quality at your business, whether you manufacture products,
distribute goods, or perform a service for your clients, your first step (and also the hardest) is
to resist the temptation to dwell on your company's flaws and instead rally your team around
the cause of rooting them out
7. Report problems that affect quality
7.1 Recognize potential or existing quality problems.
Quality affects a company in a variety of ways, from productivity and profitability to
customer satisfaction and public perception. In addition, quality affects the overall operating
costs of a company. Focusing on quality helps keep a company strong in all areas.
Productivity
Poor quality costs company money in terms of productivity problems. If a company uses low-
quality parts, systems break down, regardless of any high-quality parts also used. Low-
quality parts can cause mechanical breakdowns, as well as work slowdowns or even
stoppages.
Profitability
Quality increases profitability. When employees are engaged in a work environment in which
teamwork is emphasized and where quality products are the goal, the work environment
flows more smoothly than one in which quality is an afterthought.
Customer Satisfaction
Quality has a direct bearing on customer satisfaction. If a company produces a quality
product, satisfied customers will rank that company higher in surveys than companies that
fail to provide quality products or services. In addition, dissatisfied customers are more vocal
in their criticisms of a company with quality problems. Various websites will rank different
companies according to customer satisfaction and quality products. Poor companies may get
an initial sale of a product or service but it will not create repeat customers.
Costs
Quality directly affects costs in a business. While using less expensive parts and equipment
might cut costs in the short term, the long-term effects might be far more expensive. For
example, using certain software that costs less might save a company money in the short
term, but that software might be more complicated than more expensive software or lack
customer service. In that case, employees will take longer to understand how to use the
software. On top of that, if a problem arises with the software, the lack of customer support
means it takes longer to accomplish the job, thereby costing the company more money than if
it had used a more expensive, higher quality software product.
What Businesses Can Do
Focusing on quality can help a business maintain a satisfied customer base. In turn, this
means the business might continue turning a profit. If a business is not profitable, examining
the quality of the product or service is an important step to finding a solution. When focusing
on quality, it must be a team effort, with everyone within the company committed to
implementing any quality changes managers’ mandate. Although the initial cost might seem

27
expensive, the overall costs of ensuring delivery of quality products and services might prove
to be less than expected.
Major Factors that Affect the Quality of Manufactured Products
The term quality as applied to manufactured products may be defined as that characteristics
or combination of characteristics which distinguishes one article from another, or the goods
of one manufacturer from those of their competitors, or one grade of product from another
when both are turned out by the same factory.
Image source: verotechsolutions.net
Quality is dual: on the one hand it serves to identify the article and on the other, it is
equivalent to the degree of perfection. It is not absolute and can only be judged or realized by
comparison with some pre-determined standard(s).
When such a standard(s) has (have) been specified, then the quality of the product can be
described as “better or worse” or “higher or lower” than the established quality
specification(s). In other words, quality is a variable and, when the permissible limits of
variability have been stated, quality can be adequately defined for all practical purposes.
Factors Affecting Quality:
The factors affecting quality are:
1. Money
2. Materials
3. Management
4. People
5. Market
6. Machines and Methods.
1. Money:
Most important factor affecting the quality of a product is the money involved in the
production itself. In the present day of tough and cut throat competition, companies are
forced to invest a lot in maintaining the quality of products.
2. Materials:
To turn out a high quality product, the raw materials involved in production process must be
of high quality.
3. Management:
Quality control and maintenance programmes should have the support from top management.
If the management is quality conscious rather than merely quantity conscious, organisation
can maintain adequate quality of products.
4. People:
People employed in production, in designing the products must have knowledge and
experience in their respective areas.
5. Market:
Market for the product must exist before quality of the product is emphasized by
management. It is useless to talk about the quality when the market for the product is lacking.
For example, there is no demand for woolen garments in the hot climates (e.g., Southern part
of India).
6. Machines and Methods:
To maintain high standards of quality, companies are investing in new machines and
following new procedures and methods these days.
7.2 Identify instances of variation in quality from specifications or work instructions.
There are different types of specifications, which generally are mostly types of documents,
forms or orders or relates to information in databases. The word Specification merely refers
to the act of "To state explicitly or in detail" or "to be Specific". A specification may refer to
a type of technical standard

28
Using the word "specification" without additional information to what kind of specification
you refer to is confusing and considered bad practice within systems engineering.
A Requirement specification is a set of documented requirements to be satisfied by a
material, design, product, or service.
A Functional specification is closely related to the requirement specification and may show
functional block diagrams.
A Design or Product specification describes the features of the solutions for the
Requirement Specification, referring to the designed solution or final produced solution.
Sometimes the term specification is here used in connection with a data sheet (or spec sheet).
This may be confusing. A data sheet describes the technical characteristics of an item or
product as designed and/or produced. It can be published by a manufacturer to help people
choose products or to help use the products. A data sheet is not a technical specification as
described in this article.
A "In-service" or "Maintained as" specification, specifies the conditions of a system or
object after years of operation, including the effects of wear and maintenance (configuration
changes).
Specifications may also refer to technical standards, which may be developed by any of
various kinds of organizations, both public and private. Example organization types include a
corporation, a consortium (a small group of corporations), a trade association (an industry-
wide group of corporations), a national government (including its military, regulatory
agencies, and national laboratories and institutes), a professional association (society), a
purpose-made standards organization such as ISO, or vendor-neutral developed generic
requirements. It is common for one organization to refer to (reference, call out, cite) the
standards of another. Voluntary standards may become mandatory if adopted by a
government or business contract.
In engineering, manufacturing, and business, it is vital for suppliers, purchasers, and users of
materials, products, or services to understand and agree upon all requirements. [2] A
specification is a type of a standard which is often referenced by a contract or procurement
document. It provides the necessary details about the specific requirements.
A product specification does not necessarily prove a product to be correct or useful. An item
might be verified to comply with a specification or stamped with a specification number: This
does not, by itself, indicate that the item is fit for any particular use. The people who use the
item (engineers, trade unions, etc.) or specify the item (building codes, government, industry,
etc.) have the responsibility to consider the choice of available specifications, specify the
correct one, enforce compliance, and use the item correctly. Validation of suitability is
necessary.
Specification need
Specifications are needed to avoid errors due to lack of compatibility, for instance, in
interoperability issues.
For instance, when two applications share Unicode data, but use different normal forms or
use them incorrectly, in an incompatible way or without sharing a minimum set of
interoperability specification, errors and data loss can result.In one specific instance, the
combination of OS X errors handling composed characters, and the samba file- and printer-
sharing software (which replaces decomposed letters with composed ones when copying file
names), has led to confusing and data-destroying interoperability problems.[21][22]
Applications may avoid such errors by preserving input code points, and only normalizing
them to the application's preferred normal form for internal use.
Such errors may also be avoided by with algorithms normalizing both strings before any
binary comparison.

29
However errors due to file name encoding incompatibilities have always existed, due to a
lack of minimum set of common specification between software hoped to be inter-operable
between various file system drivers, operating systems, network protocols, and thousands of
software packages.
Formal specification
A formal specification is a mathematical description of software or hardware that may be
used to develop an implementation. It describes what the system should do, not (necessarily)
how the system should do it. Given such a specification, it is possible to use formal
verification techniques to demonstrate that a candidate system design is correct with respect
to that specification. This has the advantage that incorrect candidate system designs can be
revised before a major investment has been made in actually implementing the design. An
alternative approach is to use provably correct refinement steps to transform a specification
into a design, and ultimately into an actual implementation, that is correct by construction.
Statistical process control
Statistical process control (SPC) is a method of quality control which uses statistical
methods. SPC is applied in order to monitor and control a process. Monitoring and
controlling the process ensures that it operates at its full potential. At its full potential, the
process can make as much conforming product as possible with a minimum (if not an
elimination) of waste (rework or scrap). SPC can be applied to any process where the
"conforming product" (product meeting specifications) output can be measured. Key tools
used in SPC include control charts; a focus on continuous improvement; and the design of
experiments. An example of a process where SPC is applied is manufacturing lines.

Objective analysis of variation

SPC must be practiced in 2 phases: The first phase is the initial establishment of the process,
and the second phase is the regular production use of the process. In the second phase, a
decision of the period to be examined must be made, depending upon the change in 4 - M
conditions (Man, Machine, Material, Method) and wear rate of parts used in the
manufacturing process (machine parts, jigs, and fixture)
Understanding Process Variation
It is well established that there exist eight dimensions of quality:
1. Conformance
2. Performance
3. Features
4. Reliability
5. Durability
6. Serviceability
7. Aesthetics
8. Perceived quality
Each dimension can be explicitly defined and is self-exclusive from the other dimensions of
quality. A customer may rate your service or product high in conformance, but low in
reliability. Or they may view two dimensions to work in conjunction with each other, such as
durability and reliability.
This article will discuss the dimension of conformance and how process variation should be
interpreted. Process variation is important in the Six Sigma methodology, because the
customer is always evaluating our services, products and processes to determine how well
they are meeting their critical to quality’s (CTQs); in other words, how well they conform to
the standards.
Understanding Conformance

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Conformance can simply be defined as the degree to which your service or product meets the
CTQs and predefined standards. For the purpose of this article, it should be noted that your
organization’s services and products are a function of your internal processes, as well as your
supplier’s processes. (We know that everything in business is a process, right?)
Here are a few examples:
1. You manufacture tires and the tread depth needs to be 5/8 inch plus or minus 0.05
inch.
2. You approve loans and you promise a response to the customer within 24 business
hours of receipt.
3. You write code and your manager expects less than five bugs found over the life of
the product per thousand lines of code written.
4. You process invoices for healthcare services and your customers expect zero errors on
their bills.
A simple way to teach the concept of how well your service or product conforms to the CTQs
is with a picture of a target. A target, like those used in archery or shooting, has a series of
concentric circles that alternate color. In the center of the target is the bullseye. When
services or products are developed by your organization, the bullseye is defined by CTQs, the
parts are defined by dimensional standards, and the materials are defined by purity
requirements. As we see from the four examples above, the conformance CTQs usually
involve a target dimension (the exact center of the target), as well as a permissible range of
variation (center yellow area).
Figure 1: Targeting Process Variation

In Figure 1, three pictures help explain the variation in a process. The picture on the left
displays a process that covers the entire target. While all the bullets appear to have hit the
target, very few are in the bulls eye. This is an example of a process that is centered around
the target, but very seldom meets the CTQs of the customer.
The middle picture in Figure 1 displays a process that is well grouped on the target (all the
bullets hit the target in close proximity to each other), but is well off target. In this picture –
like in the first picture – almost every service or product produced fails to meet the customer
CTQs.
The far right picture in Figure 1 displays a process that is well grouped on the target, and all
the bullets are within the bulls eye. This case displays a process that is centered and is within
the tolerance of the customer CTQs. Because this definition of conformance defines “good
quality” with all of the bullets landing within the bulls eye tolerance band, there is little
interest in whether the bullets are exactly centered. For the most part, variation (or dispersion)
within the CTQ specification limits is not an issue for the customer.
Relating the Bulls eye to Frequency Curves
In the real-world, we seldom view our processes as bulls eyes (unless you work at a shooting
range). So how can you determine if your process is scattered around the target, grouped well
but off the bulls eye, or grouped well on the bulls eye? We can display our data in frequency
distributions showing the number (percentage) of our process outputs having the indicated
dimensions.
Figure 2: Targeting Process Variation With The Process Capability Ratio

31
One can easily see the direct relationship of Figure 2 to Figure 1. In Figure 2, the far left
picture displays wide variation that is centered on the target. The middle picture shows little
variation, but off target. And the far right picture displays little variation centered on the
target. Shaded areas falling between the specification limits indicate process output
dimensions meeting specifications; shaded areas falling either to the left of the lower
specification limit or to the right of the upper specification limit indicate items falling outside
specification limits.
Interpreting Process Variation
Most Black Belts have little time to completely understand the variation of their process
before they move into the Improve phase of DMAIC (Define, Measure, Analyze, Improve,
Control). For instance, do the critical X‘s of your process have a larger impact on variation
(spread) or central tendency (centering)? Segmentation or subgrouping the data can help you
find the correct critical X. Hypothesis testing will help you prove that it is so.
7.3 Report variation and potential problems to supervisor/manager according to enterprise
guidelines.
Consumers can play an important public health role by reporting to FDA any adverse
reactions or other problems with products the agency regulates. FDA is responsible for
ensuring that foods are safe, wholesome, and correctly labeled. It also oversees medicines,
medical devices (from bandages to artificial hearts), blood products, vaccines, cosmetics,
veterinary drugs, animal feed, and electronic products that emit radiation (such as microwave
ovens and video monitors), ensuring that these products are safe and effective.
Why should I report?
The testing that helps to establish the safety of products, such as drugs and medical devices,
is typically conducted on small groups before FDA approves the products for sale. Some
problems can remain unknown, only to be discovered when a product is used by a large
number of people.
When problems with FDA-regulated products occur, the agency wants to know about them
and has several ways for the public to make reports. Timely reporting by consumers, health
professionals, and FDA-regulated companies allows the agency to take prompt action. The
agency evaluates each report to determine how serious the problem is, and, if necessary, may
request additional information from the person who filed the report before taking action.
Product Problems
Product problems should be reported to the FDA when there is a concern about the quality,
authenticity, performance, or safety of any medication or device. Problems with product
quality may occur during manufacturing, shipping, or storage. They include:
 suspect counterfeit product;
 product contamination;
 defective components;
 poor packaging or product mix-up;
 questionable stability;
 device malfunctions; and
 labeling concerns.

32
 With drugs, a pharmacist is often the first to recognize a product quality problem. Nurses are
often the first to recognize a problem with a medical device. Report these suspicions to FDA
through MedWatch.
Examples
 A physician reported to her hospital pharmacist that she suspected the epoetinalfa
administered to a patient might be counterfeit due to unusual local reaction to the
injection. The pharmacist, after inspecting the vial, label, and packaging, noted
differences in the quality of the packaging between the suspect sample and other lots.
A Med Watch report was submitted to FDA. Subsequent investigations determined
that the product was counterfeit and contaminated with bacteria.
 A customer returned to the pharmacy after purchasing a bottle of a liquid antacid and
complained about the foul odour coming from the product when it was opened. The
pharmacist took note of the terrible odour and also observed that the plastic bottle
container was distended. The customer was given a similar product to replace this
antacid. Next, the pharmacist checked the storeroom stock and checked the lot
numbers of the affected product. Then the FDA was contacted to relay this drug
product quality concern and to provide the necessary facts to investigate this
production lot.
 While stocking a box of 15 cc bottles of Syrup of Ipecac, a pharmacy technician
noticed that one translucent bottle labelled as Syrup of Ipecac had a much brighter
colour than the rest. FDA was immediately contacted through its voluntary reporting
program. Within one day an investigation was underway. It was discovered that the
translucent product was not Syrup of Ipecac but another agent, that while not toxic
would not produce the desired effect of Syrup of Ipecac if used to treat a case of
poisoning. The investigation of this labelling mix-up resulted in the product being
recalled.
 A pharmacist observed that a 5cc unit bottle of diphenhydramine syrup made a
rattling noise when shaken. After removing the seal, it became obvious that the noise
was caused by loose glass fragments floating in the syrup. Recognizing the life-
threatening nature of this product if swallowed, FDA was contacted. An FDA
investigator picked up the samples and initiated an investigation at the manufacturer.
The results revealed a problem with the production of glass bottles. This report
resulted in a nationwide recall of the product.
 A nurse noted a frayed cable leading to the pendant (hand control) of a hospital bed.
An investigation showed that the wiring was faulty and had a tendency to fray at its
point of entry into the pendant housing.
The product variation is a change of the product properties in timing. I.e. a "old"
product is changed and replaced by a new. The "old" product is no longer continued
to produce thereafter.

Summary
 Implementing a quality control program has numerous benefits for your business. By setting
a high standard to work toward, you raise your chances of producing a perfect product and
thus increasing customer satisfaction.
 There are different types of specifications, which generally are mostly types of documents,
forms or orders or relates to information in databases.

33
 The word Specification merely refers to the act of "To state explicitly or in detail" or "to be
Specific". A specification may refer to a type of technical standard
 Critical control point (CCP) is the point where failure of standard operation procedure
(SOP) could cause harm to customers and to the business, or even loss of the business itself.
 A hazard is defined as a "Condition, event, or circumstance that could lead to or contribute to
an unplanned or undesirable event." Seldom does a single hazard cause an accident or a
functional failure.
 More often an accident or operational failure occurs as the result of a sequence of causes. A
hazard analysis will consider system state, for example operating environment, as well as
failures or malfunctions.
 While in some cases, safety or reliability risk can be eliminated; in most cases a certain
degree of risk must be accepted.
 In order to quantify expected costs before the fact, the potential consequences and the
probability of occurrence must be considered.
 Assessment of risk is made by combining the severity of consequence with the likelihood of
occurrence in a matrix. Risks that fall into the "unacceptable" category (e.g., high severity
and high probability) must be mitigated by some means to reduce the level of safety risk.
 A hazard control program consists of all steps necessary to protect workers from exposure to
a substance or system, the training and the procedures required to monitor worker exposure
and their health to hazards such as chemicals, materials or substance, or other types of
hazards such as noise and vibration.
 A legal limit or guideline (such as an exposure limit) should never be viewed as a line
between "safe" and "unsafe". The best approach is to always keep exposures or the risk of a
hazard as low as possible.
assignment
Multiple choice questions
1. _______ is a set of documented requirements to be satisfied by a material, design, product, or
service.
A. Requirement specification
B. Functional specification
C. Design or Product specification
D. In-service" or "Maintained as" specification
2. _______ specifies the conditions of a system or object after years of operation, including the
effects of wear and maintenance (configuration changes).
A. Requirement specification
B. Functional specification
C. Design or Product specification
D. In-service" or "Maintained as" specification
3. ______-is the point where failure of standard operation procedure (SOP) could cause harm to
customers and to the business, or even loss of the business itself.
A. Requirement specification
B. Functional specification
C. Design or Product specification
D. In-service" or "Maintained as" specification
E. Critical control point (CCP)
4. choosing a hazard control method may involve:
A. Evaluating and selecting temporary and permanent controls.
B. Implementing temporary measures until permanent (engineering) controls can be put in place.
C. Implementing permanent controls when reasonably practicable.
D. All of the above

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5. What are the main ways to control a hazard?
A. Elimination (including substitution):
B. Engineering Controls
C. Administrative Controls:
D. Personal Protective Equipment:
E. Where are controls used?
F. All of the above
6. Controls are usually placed:
A. At the source (where the hazard "comes from").
B. Along the path (where the hazard "travels").
C. At the worker.
D. All of the above
7. The basic types of engineering controls are:
A. Process control.
B. Enclosure and/or isolation of emission source.
C. Ventilation.
D. All of the above
8. Examples of personal hygiene practices include:
A. Washing hands after handling material and before eating, drinking or smoking.
B. Avoiding touching lips, nose and eyes with contaminated hands.
C. No smoking, drinking, chewing gum or eating in the work areas - these activities should be
permitted only in a "clean" area.
D. Not storing hazardous materials in the same refrigerator as food items.
E. All of the above
9. Safety procedures.
A. Use of tools and equipment for fabrication/production/ manufacturing works
B. Workplace environment and handling of material safety,
C. Following occupational health and safety procedures designated for the task
D. Respect the policies, regulations, legislations, rule and procedures
E. All of the above
10. The inputs to the quality assurance process are likely to include the following:
A. Quality management plan
B. Quality metrics
C. Process improvement plan
D. Work performance information
E. Approved change requests
F. Quality control measurements
G. All of the above

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