WOLAITA SODO ATVET COLLEGE

Unit of Competence: - Establishing Quality Standards

Module Title: Establishing Quality Standards

LO 1. ESTABLISH QUALITY SPECIFICATIONS FOR PRODUCT

LO2. IDENTIFY HAZARDS AND CRITICAL CONTROL POINTS

LO 3.ASSISTING PLANNING OF QUALITY ASSURANCE PROCEDURES

LO 4. MONITOR QUALITY OF WORK OUTCOME

LO 5. PARTICIPATE IN MAINTAINING AND IMPROVING QUALITY AT

WORKPLACE
 Competence description
This unit covers the knowledge, attitudes and skills required to monitor quality of work,
establish quality specifications for product, participate in maintaining and improving
quality at work, identify hazards and critical control points in the production of quality
product, assist in planning of quality assurance procedures, report problems that affect
quality and implement quality assurance procedures.

LO1. ESTABLISH QUALITY SPECIFICATIONS FOR PRODUCT

1.1 Introduction to quality standards

Quality is the standard of something as measured against other things of a similar kind; the
degree of excellence of something. It is also a distinctive attribute or characteristic possessed by
someone or something.

According to Crosby (1979): "Quality is conformance to requirements or

specifications."
A more general definition proposed by Juran (1974) is as follows: "Quality is
fitness for use."

The quality of a product or service is the fitness of that product or service for meeting or exceeding
its intended use as required by the customer. So, who is the driving force behind determining the
level of quality that should be designed into a product or service? The customer!. Therefore, as
the needs of customers change, so should the level of quality.
A product that possesses features that satisfy customer needs is a quality product. Likewise, one
that possesses features that dissatisfy customers is not a quality product. So the final arbiter on
quality is the customer.

A standard is a document established by consensus and approved by a recognized body that

provides, for common and repeated use, rules, guidelines or characteristics for activities or their
results, aimed at the achievement of the optimum degree of order in a given context.

A ‘standard’ is a result of a particular standardization effect, approved by the

recognized authority. It may take the form of a document containing a set of conditions to be
fulfilled.

Standards have certain qualities. They must be: as explicit and precise as possible; justifiable
and logically sound; acceptable (to the stakeholders); Validated; practicable; and written in
plain language.
Quality standard is a documented process intended to control work resulting in a certain level of
excellence (quality).
The standard’s degree of control is a basis for its selection for achieving that level of quality.

Quality standards are certainly ‘clear and explicit statements about key elements of a given
service’; they say ‘this is how things should be in this service’ and ‘this is what we (the purchaser
and user) have the right to expect’. They can be expressed as statements of how much, how well,
how often or how quickly something happens and can be percentages, numbers, frequencies or
cost.

Quality standards help businesses to function in an ethical way. These standards tell businesses
what minimal requirements are needed in order to ensure the public that the product or service
offered is of high quality.

Many businesses create documents outlining quality assurance standards that employees must
follow. Quality products and services are those that are free from defects and deficiencies.

Companies set their own internal standards that govern company policies, procedures, products
and employee activities. Companies must also adhere to national quality standards, such as those
set by Organization. Failure to adhere to government-imposed safety standards may result in legal
repercussions for a company.

Standardization is the process of formulating and applying the rules for an orderly approach to a
specific activity - for the benefit of all - with the co-operation of all concerned and in particular for
the promotion of optimum overall economy, taking due account of functional conditions and
safety requirements. Standardization is based on the consolidated results of science, technology
and experience. It determines not only the basis for the present but also for future development and
it should keep pace with advances.

There are several aspects of standards. These may include:

 Specifications of products and materials

 Codes of practices
 Standard test methods
 Standard terminologies, symbols, color schemes, nomenclature, notations etc.
 Standard sampling procedures
 Inspection methods
 Criteria for conformity.
There are different levels of standards, which may be listed as:
 • An Individual Standard
• A Company Standard
• An Association Standard
• A National Standard
• An International Standard

1.2. Identifying sources of market specification and requirements for

legislation
Specification refers to detailed description of how something is or should be designed or
made. Specification is exact statement of the particular needs to be satisfied, or essential
characteristics that a customer requires (in a good, material, method, process, service,
system, or work) and which a vendor must deliver. Specifications are written usually in a
manner that enables both parties (and/or an independent certifier) to measure the degree of
conformance.
Sources of market specification
 producer
 buyer/customer/consumer
 technology
 competition

Identifying requirements for legislation

The basis of requirements for legislations is:-

 Design of product
 Type of product
 Type of business organization
 Customer
 Duties, responsibilities of business organization

1.2. Developing, updating quality specification & agreeing up on it

Specifications are most detailed methods of describing requirements. Various types of

design specifications are the detailed descriptions of the materials, parts and components
to be used in making the product. They are verbal and written description that tell the
seller exactly what the buyer wants to purchase.

In a manufacturing firm, when specification is fixed, the final design of a product is also
fixed. Then the products competitiveness and its profit potential is also fixed.
To develop specifications that properly balance product quality characteristics and product
cost, management coordinate the firm technical and business skills. Four approaches can
be used.

I. Early purchasing and supply involvement

II. The formal committee approach

III. The informal approach

IV. The purchasing coordination approach

1. Early purchasing and supplier involvement

Such early involvement optimizes the development of specifications since the technical
and commercial issues are addressed at a point where there is maximum objectivity and
flexibility. This can improve product quality and reliability while comprising
development time and reducing total material cost.

As more and more firms embraces the use of cross-functional terms in the development
new products, early purchasing and supplier involvement becomes an inherent component
of the process that culminates in the development of specifications. Progressive firms find
that this approach is an important element in their quest for quality at realistic costs.

2. The formal committee approach

A specification review committee is established with representatives from design

engineering, production engineering, purchasing, marketing, operations (including
production control), quality and standards. When a new product design proposed all
members of the committee receive copies of all drawings, bills of material and
specification. No design becomes final until it is approved by the committee.

3. The informal approach

This method emphasizes the concept of a buyer’s responsibility to “Challenge materials

request”. At the same time top management urges designers to request advice from buyers
and work with them on all items that may involve commercial considerations. Emphasis
at all times is placed on person-to-person communication and cooperation between
individual buyers and designers.

4. The purchasing coordinator approach

One or more positions are created in the purchasing department for individuals frequently
called materials engineers to serve in a liaison capacity with the design department.

Generally, there are three types of quality specifications;

a. Functional quality specification

 This quality specification defines the function, duty or role of the goods or
services. It nominates what the goods or services are broadly required to do &
defines the task or desired result by focusing on what is to be achieved rather than
how it is to be done. They do not describe the method of achieving the intended
result. This enables suppliers to provide solutions to desire problems.
b. Performance quality specification
These are quality specifications that define the purpose of the goods or services in
terms of how effectiveness it will perform, that is, in capability or performance
terms. Performance is a logical extension of function. Performance quality
specification defines the task or desired result of by focusing on what is to be
achieved. They do not describe the method of achieving the desired result. This
enables suppliers to provide solutions to desire problems.
c. Technical quality specification
These are specifications that defines the technical & physical characteristics of &
or measurements of a products such a physical aspects (for ex- dimension, color&
surface finish), design details, material properties, energy requirements, process,
maintenance requirements & operational requirements. They are used when
functional & performance characteristics are insufficient to define the requirement.

Therefore, these above listed quality specifications should be developed & updated based
on time situation, market competition, and technological changes & agreed up on it with
responsible bodies.

Self-Check 1 Written Test

Directions: Answer all the questions listed below. Illustrations may be

necessary to aid some explanations/answers.

1.What is quality?

2. List and describe the general types of quality specification?

3. What is the relationship between quality and cost? Does it increases cost or increases it?

4. Who is the driving force behind determining the level of quality that should be designed into a
product or service?

5. What is quality standard?

6. List and describe approaches to develop the specification of product?

7. What are sources of market specification?

 LO2. HAZARDS & CRITICAL CONTROL POINTS

2.1. Hazards

Hazards refer to something that can cause damage/illness or something that can
dangerous. A hazard is anything in the workplace that has the potential to harm people.

A hazard is any source of potential damage, harm or adverse health effects on something or
someone under certain conditions at work.

Hazards can include objects in the workplace, such as machinery or dangerous chemicals.

Types of hazards:

A common way to classify hazards is by category:

 Biological hazards - bacteria, viruses, insects, plants, birds, animals, and humans, etc…
And contamination of other animals (like mice, rats, cats) and poor housing/transport
conditions, dirty water affects animal health and food quality.
 Chemical hazards - depends on the physical, chemical and toxic properties of the
chemical. Resulting from residues like antibiotics, pesticides, alkaloids, and other
substances used in animal production.
 Ergonomic hazards - repetitive movements, improper set up of workstation, etc.,
 Physical hazards - radiation, magnetic fields, pressure extremes (high pressure or
vacuum), noise, etc,
 Psychosocial hazards - stress, violence, etc.,
 Safety hazards - slipping/tripping hazards, inappropriate machine guarding, equipment
malfunctions or breakdowns
 Food quality hazards resulting from poor handling of animals, unhealthy or diseased
animals, inappropriate use of dogs, extreme weather conditions, poor loading and
transport conditions, and time off feed.

2.1 Identifying Critical Control Points Impacting on Quality

Critical control point is specific point, procedure, or step in food manufacturing at which
control can be exercised to reduce, eliminate, or prevent the possibility of a food safety
hazard.

A Critical Control Point (CCP) is defined as a factor, practice, procedure, process or location
that can be controlled in order to prevent, control, eliminate or reduce a hazard, or minimize the
likelihood of its occurrence.

Hazard analysis critical control point/HACCP is a management system in which food

safety is addressed through the analysis and control of biological, chemical, and physical hazards
from raw material production, procurement and handling, to manufacturing, distribution and
consumption of the finished product. 

There are seven principles of HACCP that need to be used and implemented in any food
industry throughout the world. These principles include the following:
 a) Hazard Analysis
This process includes recognizing any hazards to food safety in a particular manufacturing
program. A plan should be put into place to prevent any danger from those hazards, which could
include biological or chemical contamination.

b) Critical Control Points

The second principle is to recognize critical control points. These would be points in the
manufacturing of the food that could pose the most risk. All hazards must be found and managed
during this process.

c) Critical Limits
Control points will need critical limits. These limits, which include both minimums and
maximums, must be followed. Any breaks in limits will need to be addressed and handled.

d) Critical Control Monitoring

This monitoring standard is set into place to ensure all critical control points are noted and
watched for any changes that could lead to risk. Critical limits will also be monitored during this
principle.

e) Corrective Action
There should be a plan for specific corrective actions should a hazard arise at a critical control
point. This could include a critical limit minimum not being met, or alternatively, a critical limit
maximum being overtaken. Corrective actions should be used immediately to avoid any injury or
illness to humans from the hazard.

f) Procedures
A set of procedures should be set forth in order to ensure HACCP is always followed and
implemented correctly in the food manufacturing workplace. All employees involved in the
process should be able to verify the steps for which they are responsible.

g) Record Keeping
Any food manufacturing or packaging facility should keep verifiable and accurate records. This
should include details of their own HACCP plan as well as their own established critical control
points and critical limits. If corrective action has to be taken, then this should be documented as
well

2.3 Determining Degree of Risk for each Hazard

Risk is the chance or probability that a person will be harmed or experience an adverse
health effect if exposed to a hazard. It may also apply to situations with property or
equipment loss.

 Factors that influence the degree of risk include:

 how much a person is exposed to a hazardous thing or condition,

 how the person is exposed (e.g., breathing in a vapor, skin contact), and
 How severe are the effects under the conditions of exposure.

 Procedures for controlling hazard & risk

Step 1 – Identify hazards

Identifying hazards involves finding all of the foreseeable hazards in the workplace and
understanding the possible harm that the hazards may cause.

Step 2 – Assess risks

Risk assessment is a process for developing knowledge and understanding about hazards and risks
so that sound decisions can be taken about control. A formal risk assessment is unnecessary if the
knowledge and understanding already exist. However, there will be many times when a risk
assessment is the best way of building knowledge and understanding.

Risk assessment assists in determining:

 what levels of harm can occur

 how harm can occur
 the likelihood that harm will occur.

Step 3 – Control hazards and risks

Duty-holders are required to ensure health and safety by controlling risks.
Arriving at appropriate controls involves:
 Identifying the options for controls. A control option may be a single control or it
may be made up of a number of different controls that together provide
protection against a risk.
 Considering the control options and selecting a suitable option that most
effectively eliminates or reduces risk in the circumstances.
 Implementing the selected option.

Methods for Controlling Hazards

The best way to protect workers is to remove or eliminate the hazard from the workplace using
the following hazard control methods:

Substitution:  Substitute dangerous chemicals, equipment or work methods with safer and less
hazardous ones to eliminate the hazard altogether.  Example: Replace the open-topped manual
skinner used for skinning pieces of meat with an automated skinner.  The manual skinner exposes
workers to the hazards of amputations and skinning of the hands and forearms, while the automatic
skinner feeds the meat on a conveyor belt to an enclosed blade.

Engineering Controls:  Engineering controls are used to make changes to the work environment,
machine or piece of equipment, often reducing the hazard at the source.  Example: Exhaust
ventilation can be used to remove a harmful substance such as carbon dioxide (dry ice) from the
air.

Least Effective Hazard Controls  

Work Practice and/or Administrative Controls.  Work practice controls change the way
workers do their jobs to reduce exposure to hazards.  Administrative controls address how
the work is structured, such as work pace and breaks.  Example: Rotating workers to
reduce the amount of time they are exposed to the hazard and providing training.

I. Personal Protective Equipment (PPE).

  PPE is the least effective way to protect workers from workplace hazards because if the
equipment fails, workers are exposed to the hazard. PPE includes respirators, face and eye
protection, hearing protection, gloves, and protective clothing.
PPE, work practice controls, and administrative controls are considered the least effective
hazard controls.  These methods don’t get rid of the hazard.  Rather, they provide
protection and reduce exposure, but the hazardous condition still remains.  These controls,
however, are always going to be necessary in the meatpacking, poultry and food
processing industries.  Example:  Metal mesh gloves are often the only way to protect
workers from knife cuts, but the hazard of exposure to sharp knives is still

Step 4 – Check controls

Common methods used to check the effectiveness of controls are:

 inspecting the workplace

 consulting employees
 testing and measuring
 using available information analyzing records and data.
 LO3. ASSISTING PLANNING OF QUALITY ASSURANCE
PROCEDURES

Introduction

Quality assurance is a way of preventing mistakes or defects in manufactured products and

avoiding problems when delivering solutions or services to customers. It comprises administrative
and procedural activities implemented in quality system so that requirements and goals for a
product or activity will be fulfilled. It is also the systematic measurement , comparison with a
standard , monitoring of processes an associated feedback loop that confers error prevention.

QA includes management of quality of raw materials, assemblies, products and components,

services related to production and management , production and inspection process.

3.1 Developing Procedures for each Identified Control Point

3.2 Developing Processes to Monitor the Effectiveness of Quality Assurance Procedures

Quality assurance activities do not control quality, they establish the extent to which quality will
be, is being or has been controlled. All quality assurance activities are post-event activities and off-
line and serve to build confidence in results, in claims, in predictions, etc.

Instead of measuring the quality of products, it is necessary to measure the quality of the business
and by doing so are able to assure management and customers of the quality of products and
services.

The following steps can obtain an assurance of quality:

1. Acquire the documents that declare the organization’s plans for achieving quality
2. Produce a plan that defines how an assurance of quality will be obtained, i.e. a quality assurance
plan.

3.Organize the resources to implement the plans for quality assurance.

4. Establish whether the organization’s proposed product or service possesses characteristics that
will satisfy customer needs.
5.Assess operations, products and services of the organization and determine where and what the
quality risks are.

6 .Establish whether the organization’s plans make adequate provision for the control, elimination
or reduction of the identified risks.
7. Determine the extent to which the organization’s plans are being implemented
and risks contained.
8. Establish whether the product or service being supplied has the prescribed characteristics.

In judging the adequacy of provisions you will need to apply the relevant standards, legislation,
codes of practice and other agreed measures for the type of operation, application and business.
These activities are quality assurance activities and may be subdivided into design assurance,
procurement assurance, manufacturing assurance etc. Auditing, planning, analysis, inspection and
test are some of the techniques that may be used.

LO 4: MONITOR QUALITY OF WORK OUTCOME

4.1 Identifying Quality Requirements

The quality requirements are defined in terms of:

a) Quality factors

b) Quality criteria

c) Quality metrics

A) 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 or
not.

B) 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 or not.

C) Quality Metrics

The quality metrics document the indicators to be used to measure service and
product quality.

4.2. Inspecting Inputs to confirm capability to meet quality requirements

An inspection is, most generally, an organized examination or formal evaluation exercise.

Inspections may be a visual inspection or involve sensing technologies such as ultrasonic testing,
accomplished with a direct physical presence or remotely such as a remote visual inspection and
manually or automatically such as an automated optical inspection.

The term inspection refers to the activity of checking products, whereas audit applies to
analyzing manufacturing processes and/or systems. The quality inspector usually follows a pre-
established checklist that is based on the product specifications. Inspected products can be the
components used for production, semi-finished goods, or (most often) finished goods before
shipment to a customer.

To decrease quality risk, the inputs can be inspected prior to production.

Samples are randomly taken and checked.

An experienced inspector examines the sample/prototype to make sure that

 the raw materials meet the specified standards

"Garbage in, garbage out”: a factory usually cannot turn defective inputs (components, or raw
materials) into good products. And the problems are much harder to detect once the materials are
embedded in the final product. Thus, to decrease quality risks, the inputs can be inspected prior to
production. Some samples can be taken randomly and checked visually (or sent to a laboratory for
tests). Also, the buyer should clearly define what inputs are acceptable before he gives any order.

LO 5: PARTICIPATE IN MAINTAINING AND

IMPROVING QUALITY AT WORKPLACE
5.1 Routinely Monitoring Work Area, Materials, Processes and Product
Workers who handle livestock should be regularly monitored to ensure they remain
competent at this task.

 In order to comply with the quality requirement workers should:

 Monitor work environment temperatures,
 Know the effects of heat stress,
 Monitor the level of the hazardous substance in workplace,
 Introduce and monitor the quality specifications.

5.2 Identifying and Reporting Non-conformance in inputs, process,

product and/or service
Non-conformance means any failure to comply with a documented quality system/QS
procedure or requirement.

 Internal indicators of product problem/ non-conformance:

a) staff suggestions,
b) management reviews,
c) document reviews or internal audits
d) verification of purchased products.
  External indicators of product problem/non-conformance:
a) customer complaints,
b) suggestions,
c) customer rejections,
d) warranty claims,
e) external audits’ recommendation.

5.3. Taking Corrective and Preventive action

Corrective and preventive action (CAPA, also called corrective action / preventive

action, or simply corrective action) are set of actions which are required to be taken and
implemented in an organization at levels of manufacturing, documentation, procedures or
systems in order to rectify first and then eliminate the re-occurrence nonperformance
identified after systematic evaluation and analysis of root cause of the nonperformance, in
manufacturing, documentation or in system, here nonconformance may be a market
complaint or customer complaint or a failure of a machinery or a quality management
system, or misinterpretation of a written instructions to carry out a work. Corrective and
preventive action is designed by team including quality assurance personnel and the personnel
involved in at the actual observation point of non-conformance, and is required to be
systematically implemented and observed for its ability to eliminate further recurrence of such
non-confirmation in future.

Corrective actions are implemented in response to customer complaints, unacceptable

levels of product non-conformance, issues identified during an internal audit, or adverse or
unstable trends in product and process monitoring Preventive actions are implemented in
response to the identification of potential sources of non-conformity.

Corrective action refers to identification and elimination of the causes of a problem, thus
preventing their recurrence

Corrective action is: 1) Identification of root cause 2) Taking necessary actions. The
effectiveness of the corrective action taken has to be verified periodically through a
systematic approach of PDCA (Plan - Do - Check - Act) cycle.

6. Report problems that affect quality

6.1. Investigating and reporting cause of deviations

Some of the most challenging quality problems are those which are connected with defect
investigation in spite of careful planning and proper process control, certain defects may still be
revealed during assembly or in final inspection. To prevent these defects from recurring, they have
to be investigated to find the underlying causes, so that efforts can be made for its elimination.
The defects may be broadly grouped into two classes, namely, sporadic and chronic. A sporadic
defect generally signifies that some new factor has entered into the process, and unless this factor
is identified and eliminated, the process will remain out of control. Therefore, such defects have to
be investigated on priority. On the other hand, chronic defects are the various types of defects
which have been occurring in a certain percentage of the product, due to unknown causes. As these
defects also cause losses to the company, their incidence has to be minimized, where possible.
Generally, chronic defects comprise a large number of different types of defects of varying
magnitude.

6. 2. Causes of Quality Deviations

1. Design and Specification

a) Vague or insufficient manufacturing particulars or illegible drawing prints

b) Impracticable design or incompatible component and assembly tolerance.

c) Obsolete drawing being used.

2. Machinery and equipment

a) Inadequate process capability

b) Incorrectly designed tooling

c) Worn tools

d) Non-availability of measuring equipment

e) Poor maintenance of machines

f) Equipment affected by environment condition such as temperature, humidity etc;

3. Materials

a) Use of untested materials.

b) Mix-up of materials

c) Substandard material accepted on concession because of the non-availability of

correct material

4. Operating and supervisory staff

a) Operator does not possess adequate skill for operating the process equipment.

b) Operator does not understand the manufacturing drawing or instructions relating

to the process.

c) Machine setter does not know how to correctly set the machine.

d) Careless operator and inadequate supervision

 e) Undue rush by the operator to achieve quantity targets

5. Process control and inspection

a. Inadequate process controls

b. Non availability of proper test equipment

c. Test equipment out of calibration

d. Vague inspection /testing instructions

e. Inspectors do not possess the necessary skill