GREAT COLLEGE

ACCOUNTING
LEVEL IV
Learning Guide #16
ESTABLISH QUALITY STANDARDS
LG Code: EIS ACO4 M16 LO1-LO7

TTLM Code: EIS ACO4 M16 TTLM 0119V1

LEARNING OUTCOMES:
LO1: Establish quality specifications for product
LO2: Identify hazards and critical control points
LO3: Assist in planning of quality assurance procedures
LO4: Implement quality assurance procedures
LO5: Monitor quality of work outcome
LO6: Participate in maintaining and improving quality at work
LO7: Report problems that affect quality
August, 2019
MODULE TITLE: Establishing Quality Standards
Nominal Duration: 845 Hours
Learning Outcomes:
At the end of this module the trainer will be able to
LO1: Establish quality specifications for product
LO2: Identify hazards and critical control points
LO3: Assist in planning of quality assurance procedures
LO4: Implement quality assurance procedures
LO5: Monitor quality of work outcome
LO6: Participate in maintaining and improving quality at work
LO7: Report problems that affect quality
LO1: Establish quality specifications for product (13 Hrs)
1.1 Market specifications are sourced and legislated requirements identified.
1.2 Quality specifications developed and agreed upon
1.3 Quality specifications are documented and introduced to organization staff / personnel in
accordance with the organization policy
1.4 Quality specifications are updated when necessary
LO2: Identify hazards and critical control points (17 Hrs)
2.1 Critical control points impacting on quality are identified.
2.2 Degree of risk for each hazard is determined.
2.3 Necessary documentation is accomplished in accordance with organization quality
procedures
LO3: Assist in planning of quality assurance procedures (5 Hrs)
3.1 Procedures for each identified control point are developed to ensure optimum quality.
3.2 Hazards and risks are minimized through application of appropriate controls.
3.3 Processes to monitor the effectiveness of quality assurance procedures are developed.
LO4: Implement quality assurance procedures (18 Hrs)
4.1 Responsibilities for carrying out procedures are allocated to staff and contractors.
4.2 Instructions are prepared in accordance with the enterprise’s quality assurance program.
4.3 Staff and contractors are given induction training on the quality assurance policy.
4.4 Staff and contractors are given in-service training relevant to their allocated procedures.
LO5: Monitor quality of work outcome (14 Hrs)
5.1 Quality requirements are identified
5.2 Inputs are inspected to confirm capability to meet quality requirements
5.3 Work is conducted to produce required outcomes
1
5.4 Work processes are monitored to confirm quality of output and/or service
5.5 Processes are adjusted to maintain outputs within specification.
LO6: Participate in maintaining and improving quality at work (10 Hrs)
6.1 Work area, materials, processes and product are routinely monitored to ensure compliance
with quality requirements
6.2 Non-conformance in inputs, process, product and/or service is identified and reported
according to workplace reporting requirements
6.3 Corrective action is taken within level of responsibility, to maintain quality standards
6.4 Quality issues are raised with designated personnel
LO7: Report problems that affect quality (7 Hrs)
7.1 Recognize potential or existing quality problems.
7.2 Identify instances of variation in quality from specifications or work instructions
7.3 Report variation and potential problems to supervisor/manager according to enterprise
guidelines.

2
 INFORMATION SHEET 1
LO1: ESTABLISH QUALITY SPECIFICATIONS FOR PRODUCT (13 Hrs)
1.1. Source of market specifications & legislation
Sourced include:
 Purchasers of the product e.g., processors or end-use customers.
1.1.1. Development and agreement of quality specifications
Specification is a detailed description of the designs and materials used to make a standard.
The specifications characteristics:
 Market specifications are sourced and legislated requirements identified.
 Quality specifications developed and agreed upon
 Quality specifications are documented and introduced to organization staff / personnel in
accordance with the organization policy
 Quality specifications are updated when necessary
1.1.2. Introduction and documentation of quality specifications
Recording of work quality have many importances:
 To set the future working situation n
 To achieve maximum production services
 To have qualified professionals in this frame work of quality standards
 To be competent in the market demand
1.1.3. Quality specifications updating
Specification is a detailed description of the designs and materials used to make a standard.
The specifications characteristics:
 Market specifications are sourced and legislated requirements identified.
 Quality specifications developed and agreed upon
 Quality specifications are documented and introduced to organization staff / personnel in
accordance with the organization policy
 Quality specifications are updated when necessary

OPERATION TITLE: Develop quality specifications

PURPOSE: To organization staff / personnel
EQUIPMENT TOOLS AND MATERIALS:
Computer, soft ware, CD-R/RW, DVD/CDRW, printer, pen, paper, flip chart, marker, flash disk
CONDITIONS OR SITUATION FOR THE OPERATIONS:
Existence of quality specifications
PROCEDURE:
1. Identify market specifications sourced and legislated requirements
2. Develop and agree upon quality specifications
3. Document and introduce quality specifications to organization staff / personnel in accordance with the
organization policy
4. Update quality specifications when necessary
PRECAUTIONS:
Document and introduce quality specifications to organization staff / personnel in accordance
with the organization policy
QUALITY CRITERIA:
Update quality specifications when necessary

3
 INFORMATION SHEET 2
LO2: IDENTIFY HAZARDS AND CRITICAL CONTROL POINTS (17 Hrs)
2.1. Impact of critical control points on quality
Hazard Analysis and Critical Control Points (HACCP)
The intent of HACCP is to help prevent known hazards and to reduce the risks that they will
occur at any point in a process through the execution of seven core action:
1. Conduct a Hazard Analysis
2. Determine the Critical Control points
3. Establish Target Levels and Critical Limits
4. Establish System(s) to monitoring Critical Control points
5. Establish an appropriate Corrective Action Plan for each Critical Control points.
6. Establish Procedures to verify that the HACCP system is working effectively
7. Establish Documentation concerning all procedures and keep records of their application.
Because the approach enforces procedural governance and rigorous documentation practices,
HACCP serves not only as a model to assess risk, but also as an effective means to communicate
risk control.
This document presents some core steps in the execution of HACCP. Successful application of
any risk management model requires that tools are used in concert with the quality risk
management process.
Usage:
 The Hazard Analysis and Critical Control Point (HACCP) System:
 Is focused on safety hazards – typical safety hazards include biological, chemical or physical
agents or operations that could lead to illness or injury if not controlled
 Typically, includes an entire process (e.g., for pharmaceutical manufacturing, it typically
encompasses raw material receipt through distribution to the consumer)
 Is implemented through a plan that details the initial analysis and the on-going monitoring
and review. The Plan is a “living” system; not a one-time assessment.
 Generates a “HACCP Control Chart” listing the potential hazards, preventive measures,
critical limits, monitoring systems and corrective actions associated with each Critical
Control Point.
Quality Risk Management Applications
HACCP is well-suited for a variety of applications, including:
 To identify microbiological hazards and their controls in a process

4
  As an input to define Critical Process Parameters and the associated action and alert
limits for those parameters
 As a structure to evaluate, support and communicate the effectiveness of cleaning and
sanitization processes
 To evaluate the impact of operator actions on the quality and safety of a product.
Hazard Analysis and Critical Control Points (HACCP)
Hazard Analysis and Critical Control Point (HACCP) has been defined by the World Health
Organization as “a scientific, rational and systematic approach for the identification, assessment
and control of hazards.1” Originally developed to focus on food safety hazards; the HACCP
system has been successfully applied to other applications and other industries.
The intent of HACCP is to help prevent known hazards and to reduce the risks that they will
occur at any point in a process through the execution of seven core action:
1. Conduct a Hazard Analysis
2. Determine the Critical Control points (CCPs)
3. Establish Target Levels and Critical Limits
4. Establish System(s) to monitoring CCPs
5. Establish an appropriate Corrective Action Plan for each CCP.
6. Establish Procedures to verify that the HACCP system is working effectively
7. Establish Documentation concerning all procedures and keep records of their application.
Because the approach enforces procedural governance and rigorous documentation practices,
HACCP serves not only as a model to assess risk, but also as an effective means to communicate
risk control.
Usage
The Hazard Analysis and Critical Control Point (HACCP) System:
Is focused on safety hazards – typical safety hazards include biological, chemical or physical
agents or operations that could lead to illness or injury if not controlled
Typically, includes an entire process (e.g., for pharmaceutical manufacturing, it typically
encompasses raw material receipt through distribution to the consumer)
Is implemented through a plan that details the initial analysis and the on-going monitoring and
review. The Plan is a “living” system; not a one-time assessment. Generates a “HACCP Control
Chart” listing the potential hazards, preventive measures, critical limits, monitoring systems and
corrective actions associated with each Critical Control Point.
Quality Risk Management Applications
HACCP is well-suited for a variety of applications, including:
 To identify microbiological hazards and their controls in a process
5
  As an input to define Critical Process Parameters and the associated action and alert
limits for those parameters
 As a structure to evaluate, support and communicate the effectiveness of cleaning and
sanitization processes
 To evaluate the impact of operator actions on the quality and safety of a product.
Preliminary Tasks
Define Risk Question and Scope of System
The first step in any risk management effort is to define the overall risk question.
Answering the risk question represents the ultimate goal of the risk assessment.
Examples of risk questions include:
 How often should a manufacturing site be audited to assure GMP compliance?
 What root causes of non-conformances should we prioritize for remediation?
 What are the appropriate back-up inactivation methods that provide an appropriate level of
decontamination in a fermentation suite to inactivate BL2 waste and equipment when the
inactivation autoclave is unavailable?
Assemble the HACCP Team and Define Scope
Because of the complexity and variety of potential hazards with any pharmaceutical product or
process, it is important to assemble a multidisciplinary HACCP team. The scope of the effort
will indicate the type and level of expertise of required HACCP team members. For example, for
an effort focused on patient or consumer safety concerns, a HACCP team should have available
expertise in:
 Active ingredients and associated impurities and degradants
 Operations, including synthesis, manufacturing and packaging processes
 Utilities, including water systems, HVAC and electrical
 Cleaning processes, including detergents and sanitizing agents
 Process changeovers, including manual operations such as clearance practices and
equipment assembly / disassembly
 Microbiological flora inherent in raw materials, products or the environment
The HACCP seven principles:
Principle 1: Conduct a hazard analysis. – Plans determine the food safety hazards and identify
the preventive measures the plan can apply to control these hazards. A food safety hazard is any
biological, chemical, or physical property that may cause a food to be unsafe for human
consumption.

6
 Principle 2: Identify critical control points. – A critical control point (CCP) is a point, step, or
procedure in a food manufacturing process at which control can be applied and, as a result, a
food safety hazard can be prevented, eliminated, or reduced to an acceptable level.
Principle 3: Establish critical limits for each critical control point. – A critical limit is the
maximum or minimum value to which a physical, biological, or chemical hazard must be
controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.
Principle 4: Establish critical control point monitoring requirements. – Monitoring activities
are necessary to ensure that the process is under control at each critical control point
Principle 5: Establish corrective actions. – These are actions to be taken when monitoring
indicates a deviation from an established critical limit. The final rule requires a plant's HACCP
plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions
are intended to ensure that no product injurious to health or otherwise adulterated as a result of
the deviation enters commerce.
Principle 6: Establish procedures for ensuring the HACCP system is working as intended.
– Validation ensures that the plants do what they were designed to do; that is, they are successful
in ensuring the production of a safe product
Verification ensures the HACCP plan is adequate, that is, working as intended. Verification
procedures may include such activities as review of HACCP plans, CCP records, critical limits
and microbial sampling and analysis. FSIS is requiring that the HACCP plan include verification
tasks to be performed by plant personnel. Verification also includes 'validation' – the process of
finding evidence for the accuracy of the HACCP system (e.g. scientific evidence for critical
limitations).
Principle 7: Establish record keeping procedures. – The HACCP regulation requires that all
plants maintain certain documents, including its hazard analysis and written HACCP plan, and
records documenting the monitoring of critical control points, critical limits, verification
activities, and the handling of processing deviation

OPERATION TITLE: Identify critical control points impacting on quality

PURPOSE: To determine degree of risk for each hazard
EQUIPMENT TOOLS AND MATERIALS:
Computer, soft ware, CD-R/RW, DVD/CDRW, printer, pen, paper, flip chart, marker, flash disk
CONDITIONS OR SITUATION FOR THE OPERATIONS:
Existence of hazards and critical control points
PROCEDURE:
1. Acknowledge and greet customer
2. Communicate using appropriate interpersonal skills
3. Maintain sensitivity to customer specific needs
4. Establish relationship with customer
PRECAUTIONS:
Determine degree of risk for each hazard
QUALITY CRITERIA:
Accomplish necessary documentation in accordance with organization quality procedures

7
 INFORMATION SHEET 3
LO3: ASSIST IN PLANNING OF QUALITY ASSURANCE PROCEDURES 5 Hrs)
3.1. Developing quality assurance procedures for each critical control points
Quality assurance is the systematic monitoring and evaluation of the various aspects of a
project, service or facility to maximize the probability that minimum standards of quality are
being attained by the production process. Quality assurance cannot absolutely guarantee the
production of quality products. Two principles included in quality assurance are: "Fit for
purpose", the product should be suitable for the intended purpose; and "Right first time",
mistakes should be eliminated. Quality assurance includes regulation of the quality of raw
materials, assemblies, products and components, services related to production, and
management, production and inspection processes.
Quality is determined by the product users, clients or customers, not by society in general. It is
not the same as 'expensive' or 'high quality'. Low priced products can be considered as having
high quality if the product users determine them as such. Implementing Quality assurance/quality
control procedures requires resources, expertise and time. In developing any quality
assurance/quality control system, it is expected that judgments will need to be made on the
following:
 Resources allocated to quality control for different source categories and the compilation
process;
 Time allocated to conduct the checks and reviews of emissions estimates;
 Availability and access to information on activity data and emission factors, including data
quality;
 Procedures to ensure confidentiality of inventory and source category information, when
required;
 Requirements for archiving information;
 Frequency of quality assurance/quality control checks on different parts of the inventory;
 The level of quality control appropriate for each source category;
 Whether increased effort on quality control will result in improved emissions estimates and
reduced uncertainties;
 Whether sufficient expertise is available to conduct the checks and reviews.
In practice, the quality assurance/quality control system is only part of the inventory
development process and inventory agencies do not have unlimited resources. Quality control
requirements, improved accuracy and reduced uncertainty need to be balanced against
requirements for timeliness and cost effectiveness. A good practice system seeks to achieve that
balance and to enable continuous improvement of inventory estimates.
Within the quality assurance/quality control system, good practice provides for greater effort for
key source categories and for those source categories where data and methodological changes
have recently occurred, than for other source categories. It is unlikely that inventory agencies
will have sufficient resources to conduct all the quality assurance/quality control procedures
outlined in this chapter on all source categories. In addition, it is not necessary to conduct all of
these procedures every year. For example, data collection processes conducted by national
statistical agencies are not likely to change significantly from one year to the next. Once the
inventory agency has identified what quality controls are in place, assessed the uncertainty of
that data, and documented the details for future inventory reference, it is unnecessary to revisit
8
 this aspect of the quality control procedure every year. However, it is good practice to check the
validity of this information periodically as changes in sample size, methods of collection, or
frequency of data collection may occur. The optimal frequency of such checks will depend on
national circumstances.
It is recognized that resource requirements will be higher in the initial stages of implementing
any quality assurance/quality control system than in later years. As capacity to conduct quality
assurance/quality control procedures develops in the inventory agency and in other associated
organizations, improvements in efficiency should be expected.
Quality assurance procedures
Good practice for quality assurance procedures requires an objective review to assess the quality
of the inventory, and also to identify areas where improvements could be made. The inventory
may be reviewed as a whole or in parts. The objective in quality assurance implementation is to
involve reviewers that can conduct an unbiased review of the inventory. It is good practice to use
quality assurance reviewers that have not been involved in preparing the inventory. Preferably
these reviewers would be independent experts from other agencies or a national or international
expert or group not closely connected with national inventory compilation. Where third party
reviewers outside the inventory agency are not available, staff from another part of the inventory
agency not involved in the portion of the inventory being reviewed can also fulfill quality

OPERATION TITLE: Minimize hazards and risks

PURPOSE: To monitor the effectiveness of quality assurance procedures
EQUIPMENT TOOLS AND MATERIALS:
Computer, soft ware, CD-R/RW, DVD/CDRW, printer, pen, paper, flip chart, marker, flash disk
CONDITIONS OR SITUATION FOR THE OPERATIONS:
Existence of quality assurance procedures

PROCEDURE:
1. Develop procedures for each identified control point to ensure optimum quality.
2. Minimize hazards and risks through application of appropriate controls.
3. Develop processes to monitor the effectiveness of quality assurance procedures

PRECAUTIONS:
Minimize hazards and risks through application of appropriate controls.

QUALITY CRITERIA:
Develop processes to monitor the effectiveness of quality assurance procedures

assurance roles.

9
 INFORMATION SHEET 4
LO4: IMPLEMENT QUALITY ASSURANCE PROCEDURES (18 Hrs)
4.1. Allocating responsibilities
The Assignment of Responsibilities Section will address each of the Plan’s concepts of operation
and identify one-or-more individuals, agencies or organizations that will be tasked to have the
responsibility to carry out missions in response to each of the concepts of operation.
The Plan must be backed by agency-based standard operating procedures. For each assignment
of responsibility in the Plan, there must be a corresponding standard operating procedure that is
developed, maintained and trained at the agency level.
Only Agencies and Organizations that have assignments of responsibility in this plan should be
listed at the front of the plan.
The jurisdiction should draw resources from a number of sources, including:
 Local emergency responders (fire, law enforcement, emergency medical services, local
health departments, county engineer, county extension, etc.)
 Private and volunteer organizations
 Animal Industry producers and processors
The assignments of responsibility that are offered below are only suggestions. They need to be
thought through and your jurisdiction’s needs and situations must be considered before assigning
responsibilities to any support agency.
It is not intended that the following assignment of responsibility language examples be used in
their entirety as written, rather they are provided as a starting point for developing your Plan’s
assignment of responsibility section.
County Prosecutor
1. Provide legal advice to local/county organizations concerning animal disease issues, including
animal movement restrictions, quarantine orders, animal euthanasia and disposal,
indemnification and human resource issues.
2. Provide a team of personnel to address legal challenges as needed.
County Purchasing Agent
1. Assist in the identification of resource providers and purchasing supplies, equipment and
services.
2. Provide logistical support for responders
3. Coordinate with other local agencies as needed to assist in the movement and positioning of
personnel and supplies.
4. Coordinate with State and Federal agencies for reimbursement from the federal government.
10
4.2. Providing induction and in- service trainings.
Human development puts people's empowerment at the centre of development. It aims to enable
people to use their capabilities and resources to the fullest without destroying the richness of
their cultural and natural environment. It also recognises that not much can be achieved without
the improvement in the status of women and the opening up of opportunities to them.
One of the major factors that have slowed human development is the lack of people's
participation in the design and implementation of policies and programmes that affect their lives.
Unless people become the protagonists of their own development, no amount of investment or
provision of technology will improve standards of living in a sustainable way. The problem,
however, is that the rural and the poor who need to become active actors in their development to
enable them improve their livelihood are often beyond easy reach. They are generally illiterate,
but they have ideas, knowledge and practices shaped by deep-rooted cultural norms, traditions,
experiences and values different from those of development workers. These peculiarities or
differences render the task of involving rural people in the planning and implementation of
development efforts difficult.
4.2. Preparation of instruction & quality assurance program
.Quality assurance is the systematic monitoring and evaluation of the various aspects of a
project, service or facility to maximize the probability that minimum standards of quality are
being attained by the production process. Quality assurance cannot absolutely guarantee the
production of quality products.
Two principles included in quality assurance are: "Fit for purpose", the product should be
suitable for the intended purpose; and "Right first time", mistakes should be eliminated. Quality
assurance includes regulation of the quality of raw materials, assemblies, products and
components, services related to production, and management, production and inspection
processes.
Quality is determined by the product users, clients or customers, not by society in general. It is
not the same as 'expensive' or 'high quality'. Low priced products can be considered as having
high quality if the product users determine them as such. Implementing Quality assurance/quality
control procedures requires resources, expertise and time. In developing any quality
assurance/quality control system, it is expected that judgments will need to be made on the
following:
 Resources allocated to quality control for different source categories and the compilation
process;
 Time allocated to conduct the checks and reviews of emissions estimates;

11
 Availability and access to information on activity data and emission factors, including data
quality;
 Procedures to ensure confidentiality of inventory and source category information, when
required;
 Requirements for archiving information;
 Frequency of quality assurance/quality control checks on different parts of the inventory;
 The level of quality control appropriate for each source category;
 Whether increased effort on quality control will result in improved emissions estimates and
reduced uncertainties;
 Whether sufficient expertise is available to conduct the checks and reviews.
In practice, the quality assurance/quality control system is only part of the inventory
development process and inventory agencies do not have unlimited resources. Quality control
requirements, improved accuracy and reduced uncertainty need to be balanced against
requirements for timeliness and cost effectiveness. A good practice system seeks to achieve that
balance and to enable continuous improvement of inventory estimates.
Within the quality assurance/quality control system, good practice provides for greater effort for
key source categories and for those source categories where data and methodological changes
have recently occurred, than for other source categories. It is unlikely that inventory agencies
will have sufficient resources to conduct all the quality assurance/quality control procedures
outlined in this chapter on all source categories. In addition, it is not necessary to conduct all of
these procedures every year. For example, data collection processes conducted by national
statistical agencies are not likely to change significantly from one year to the next. Once the
inventory agency has identified what quality controls are in place, assessed the uncertainty of
that data, and documented the details for future inventory reference, it is unnecessary to revisit
this aspect of the quality control procedure every year. However, it is good practice to check the
validity of this information periodically as changes in sample size, methods of collection, or
frequency of data collection may occur. The optimal frequency of such checks will depend on
national circumstances.
It is recognized that resource requirements will be higher in the initial stages of implementing
any quality assurance/quality control system than in later years. As capacity to conduct quality
assurance/quality control procedures develops in the inventory agency and in other associated
organisations, improvements in efficiency should be expected.
Quality assurance procedures
Good practice for quality assurance procedures requires an objective review to assess the quality
of the inventory, and also to identify areas where improvements could be made. The inventory
12
may be reviewed as a whole or in parts. The objective in quality assurance implementation is to
involve reviewers that can conduct an unbiased review of the inventory. It is good practice to use
quality assurance reviewers that have not been involved in preparing the inventory. Preferably
these reviewers would be independent experts from other agencies or a national or international
expert or group not closely connected with national inventory compilation. Where third party
reviewers outside the inventory agency are not available, staff from another part of the inventory
agency not involved in the portion of the inventory being reviewed can also fulfill quality
assurance roles.

OPERATION TITLE: Allocate responsibilities for staff and contractors

PURPOSE: To Implement quality assurance procedures
EQUIPMENT TOOLS AND MATERIALS:
Computer, soft ware, CD-R/RW, DVD/CDRW, printer, pen, paper, flip chart, marker, flash disk
CONDITIONS OR SITUATION FOR THE OPERATIONS:
 Existence of instructions
 Existence of in-service training
PROCEDURE:
1. Allocate responsibilities for carrying out procedures to staff and contractors.
2. Prepare instructions in accordance with the enterprise’s quality assurance program.
3. Give induction training for staff and contractors on the quality assurance policy.
4. Give staff and contractors in-service training relevant to their allocated procedures
PRECAUTIONS:
Give induction training for staff and contractors on the quality assurance policy.
QUALITY CRITERIA:
Give staff and contractors in-service training relevant to their allocated procedures

INFORMATION SHEET 5
LO5: MONITOR QUALITY OF WORK OUTCOME (14 Hrs)
5.1. Identification of quality requirements& process adjustment
The purpose is to:
 Increase awareness of the business, cultural, demographic, and legal frameworks for
understanding and managing diversity.
 Support managers, supervisors, human resource professionals, and other staff in their
efforts to respect, appreciate, and value individual differences.
 Increase agencies’ understanding of how diverse quality can:
- improve organizational performance,
- help prevent unlawful discrimination or harassment incidents,
- improve workplace relations,
- build more effective work teams,
- improve organizational problem solving, and

13
 - improve customer service.
 Identify helpful tools and strategies to obtain, retain, strengthen, and fully utilize a diverse,
high-quality workforce.
 Designing and implementing a diversity program
 Sustaining commitment
5.2. Work process monitoring
Among the factors affecting the processing and productivity of standards work area has the main
role so to achieve maximum production n the area must be safe to operate the required process.

OPERATION TITLE: Identify quality requirements

PURPOSE: To maintain outputs within specification
EQUIPMENT TOOLS AND MATERIALS:
Computer, soft ware, CD-R/RW, DVD/CDRW, printer, pen, paper, flip chart, marker, flash disk
CONDITIONS OR SITUATION FOR THE OPERATIONS:
 Existence of inputs
 Existence of work processes
PROCEDURE
1. Identify quality requirements
2. Inspect inputs to confirm capability to meet quality requirements
3. Conduct work to produce required outcomes
4. Monitor work processes to confirm quality of output and/or service
5. Adjust processes to maintain outputs within specification
PRECAUTIONS:
Monitor work processes to confirm quality of output and/or service
QUALITY CRITERIA:
Adjust processes to maintain outputs within specification

Materials also have a great role in the processing and production of well define and neat product.

INFORMATION SHEET 6
LO6: PARTICIPATE IN MAINTAINING AND IMPROVING QUALITY AT WORK (10
Hrs)
6.1. Work area, materials, processes and product monitoring
Materials include:
 swabs and plastic bags/containers to collect specimens, plastic or rubber disposable
gloves, bucket, scrubbing brush, gauze, cotton and plasters
 aluminum foils, gowns, apron, rubber boots, disinfectants, antiseptics, scalpel blade,
saline water, distilled water, stationeries, tap water, alcohol, and soap, detergents,
protective eyewear, overall, cleaning reagents cleaning materials
6.2. Non-conformance in inputs, process, product
Monitoring product process requires critical evolution before the raw materials are selected after
the evaluation of the product it can achieve maximum level of product standards.

14
The most basic quality control technique is to inspect the results of your production or service-
delivery process to make sure it conforms to customer requirements. In quality control terms,
conforming means that an item meets customer specifications, and nonconforming means it
doesn’t. You inspect your product or service by measuring one or more of its properties and
comparing the measurements to customer specifications.
Although inspection can ensure that 100 percent of the products or services you deliver to your
customers are good, it can be a very expensive process, especially for high-volume, low-value
items.
Describe the Product, Intended Use and Process
The HACCP team should first define the product(s) associated with the HACCP System.
Because each product has a unique set of process steps and associated hazards, it is important
that all products are defined through physical, chemical and biological characteristics. It is also
important to consider the intended use of a product. If a product requires another device or
another component as part of administration or use by the patient or consumer, it will be
necessary to identify the hazards associated with that process.
At this early stage in the HACCP initiative, it may be helpful to group products by their
characteristics, or by their intended use. Grouping helps to consolidate the assessment and
management of risks and streamline the effort. Grouping can be done if the processes and
intended use of a set of products are consistent. In cases where variations exist, the HACCP team
may still choose to group products and assume the worst-case based on scientific rationale
It is at this point that the HACCP team will define the process. The process should be sufficiently
detailed to highlight hazards and control points. It should depict:
 Process steps and equipment, whether manual or automated
 Direct process control elements, including online instrumentation, logic, manufacturing
procedures and testing and inspection controls
 Indirect process controls including operator gowning, maintenance, cleaning and storage
 Quality controls supporting raw material and finished product release.
 As with products, the HACCP team may choose to group similar process elements to
simplify the effort.
6.3. Corrective action & level of responsibility, to maintain quality standard
A corrective action is a term that encompasses the process of reacting to product problems
customer complaints or other nonconformities and fixing them. The process includes:
• Reviewing and defining the problem or nonconformity
• Finding the cause of the problem
• Developing an action plan to correct the problem and prevent a recurrence
15
• Implementing the plan
• Evaluating the effectiveness of the correction.
Corrective and preventive action
Corrective and preventive action (CAPA, also called corrective action / preventive action) is
a concept within good manufacturing practice. Corrective and preventive action focuses on the
systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent
their recurrence (for corrective action) or to prevent occurrence (for preventive action). To
ensure that corrective and preventive actions are effective, the systematic investigation of the
failure incidence is pivotal in identifying the corrective and preventive actions to be undertaken.
Corrective and preventive action is part of the overall quality management system.
 Clearly identified sources of data which identify problems that will be investigated.
 Root cause analysis to identify the cause of a discrepancy or deviation and suggest
corrective actions to potentially prevent recurrence of a similar problem, or preventive
action to ensure that discrepancies do not occur.
 Remedial corrections of a problem which is identified.
A common misconception is that the purpose of preventive action is to avert the occurrence of a
similar potential problem. This process is all part of corrective action, because it is a process of
determining such similarities that should take place in the event of a discrepancy.
Preventive action is any proactive methodology used to determine potential discrepancies before
they occur and to ensure that they do not happen (thereby including, for example, preventive
maintenance, management review or other common forms of risk aversion). Corrective and
preventive actions both include investigation, action, review, and further action if so required.
Investigations to root cause may conclude that no corrective or preventive actions are required,
and additionally may suggest simple corrections to a problem with no identified systemic root
cause. When multiple investigations end in no corrective action, a new problem statement with
expanded scope may be generated, and a more thorough investigation to root cause performed.
Implementation of Corrective & preventive actions is the path towards improvement &
effectiveness of Quality Management system. Corrective actions are nothing but the action/s
based on the problem identification. The problem or a non-conformance can be identified
internally through staff suggestions, management reviews, document reviews or internal audits.
Customer complaints / suggestions, customer rejections, non-conformities raised in customer /
third party audits & recommendations by the auditors are the external sources which lead to find
the root cause of the problem.
Corrective action is a reaction to any of the cause/non-conformance mentioned above & can be
divided in two phases of action: 1) Identification of root cause: for this purpose TQM tools such

16
as fish-bone or cause & effects analysis can be practiced. Your CAPA would be appropriate &
effective if & only if you have identified the root cause of problem. 2) Taking necessary actions:
in order to address the root cause takes necessary immediate action/s.
Preventive action is prediction of problem & trying to avoid the occurrence (fail safe) through
self-initiated action/s & analysis related with your processes / products. This can be initiated with
the help of active participation of staff members / workers through improvement teams,
improvement meetings, management review, customer feedback & deciding own goals quantized
in terms of business growth, reducing rejections, utilizing the equipment’s effectively etc.
Root cause analysis (RCA) is a class of problem solving methods aimed at identifying the root
causes of problems or events. The practice of root cause analysis is predicated on the belief that
problems are best solved by attempting to address, correct or eliminate root causes, as opposed to
merely addressing the immediately obvious symptoms. By directing corrective measures at root
causes, it is more probable that problem recurrence will be prevented. However, it is recognized
that complete prevention of recurrence by one corrective action is not always possible.
Conversely, there may be several effective measures (methods) that address the root cause of a
problem.
General principles of root cause analysis
1. The primary aim of RCA is to identify the root cause(s) of a problem in order to create
effective corrective actions that will prevent that problem from ever recurring, otherwise
addressing the problem with virtual certainty of success. ("Success" is defined as the
near-certain prevention of recurrence.)
2. To be effective, RCA must be performed systematically, usually as part of an
investigation, with conclusions and root causes identified backed up by documented
evidence. Usually a team effort is required.
3. There may be more than one root cause for an event or a problem, the difficult part is
demonstrating the persistence and sustaining the effort required to develop them.
4. The purpose of identifying all solutions to a problem is to prevent recurrence at lowest
cost in the simplest way. If there are alternatives that are equally effective, then the
simplest or lowest cost approach is preferred.
5. Root causes identified depend on the way in which the problem or event is defined.
Effective problem statements and event descriptions (as failures, for example) are
helpful, or even required.
6. To be effective, the analysis should establish a sequence of events or timeline to
understand the relationships between contributory (causal) factors, root cause(s) and the
defined problem or event to prevent in the future.
7. Root cause analysis can help to transform a reactive culture (that reacts to problems) into
a forward-looking culture that solves problems before they occur or escalate. More
importantly, it reduces the frequency of problems occurring over time within the
environment where the RCA process is used.
8. RCA is a threat to many cultures and environments. Threats to cultures often meet with
resistance. There may be other forms of management support required to achieve RCA
effectiveness and success. For example, a "non-punditry" policy towards problem
identifiers may be required.

17
Taking Corrective Action
Once you document a problem with respect to not doing what you said you were going to do or
not meeting objectives, you must resolve it. Take action as quickly as possible. Make sure
assigned responsibilities for actions and schedules are clear so that correction occurs in a timely
manner.
Employees in the facility may recognize the need for corrective action and provide good ideas
for solving problems. Find ways to get them involved in the improvement process. It’s important
to determine whether a lapse is temporary or due to some flaw in the procedures or controls. For
this reason, communicate any findings to employees and provide any follow-up training for
changes in the procedures that may result. The following is a checklist to help complete
corrective action. Have you:
 Identified the problem(s)?
 Identified the cause(s)?
 Come up with a solutio n for each?
 Implemented the solution(s)?
Here are some things to think about to expedite the determination of your facility’s corrective
and preventive action process:
 Combine some elements of your management review and corrective action processes if
you can. Facilities that do use a portion of their management review meetings to review
nonconformities, discuss causes and trends, identify corrective actions, and assign
responsibilities.
 Don’t go overboard with bureaucracy—simple methods often wo rk quite effectively.
The amount of planning and documentation needed for corrective and preventive actions
will vary with the severity of the problem and its potential environmental impacts.
 Be sure that your corrective and preventive action process specifies responsibilities and
schedules for completion. Once you document a problem, the facility must be committed
to resolving it in a timely manner. Review your progress regularly and follow up to
ensure that actions taken are effective.
 Make sure your actions are based on good information and analysis of causes. While
many corrective actions may be “common sense,” you need to look beneath the surface to
determine why problems occur.
 Rule of thumb: Corrective actions should: (1) resolve the immediate problem; (2)
consider whether the same or similar problems exist elsewhere in the organization; and
(3) prevent the problem from recurring. The corrective action process also should define
the responsibilities and schedules associated with these three steps.
 Find ways to get employees involved in the system improvement process (for example,
via suggestion boxes, contests, or incentive programs). Initially, most EMS problems
may be identified by your internal auditors. However, over the long run, many problems
and good ideas may be identified by the people doing the work.

18
OPERATION TITLE: Identify non-conformance in inputs, process, product and/or services
PURPOSE: To take corrective action
EQUIPMENT TOOLS AND MATERIALS:
Computer, soft ware, CD-R/RW, DVD/CDRW, printer, pen, paper, flip chart, marker, flash disk
CONDITIONS OR SITUATION FOR THE OPERATIONS:
Existence of compliance with quality requirements
Existence of quality issues
PROCEDURE:
1. Monitor work area, materials, processes and product to ensure compliance with quality
requirements
2. Identify and report non-conformance in inputs, process, product and/or service
3. Take corrective action within level of responsibility, to maintain quality standards
4. Raise quality issues with designated personnel
PRECAUTIONS:
Take corrective action within level of responsibility, to maintain quality standards
QUALITY CRITERIA:
Raise quality issues with designated personnel

INFORMATION SHEET 7
LO7: REPORT PROBLEMS THAT AFFECT QUALITY 7 Hrs)
7.1. Recognizing and reporting quality variation and problems
Recording of work quality have many importance:
 To set the future working situation
 To achieve maximum production services
 To have qualified professionals in this frame work of quality standards
 To be competent in the market demand

OPERATION TITLE: Recognize potential or existing quality problems

PURPOSE: To identify instances of variation in quality
EQUIPMENT TOOLS AND MATERIALS:
Computer, soft ware, CD-R/RW, DVD/CDRW, printer, pen, paper, flip chart, marker, flash disk
CONDITIONS OR SITUATION FOR THE OPERATIONS:
Existence of report variation and potential problems
PROCEDURE:
1. Recognize potential or existing quality problems.
2. Identify instances of variation in quality from specifications or work instructions.
3. Report variation and potential problems to supervisor/manager according to enterprise
guidelines.
PRECAUTIONS:
Identify instances of variation in quality from specifications or work instructions.
QUALITY CRITERIA:
Report variation and potential problems to supervisor/manager according to enterprise
guidelines.

19