Business and finance

Accounts and budget support level III

Unit of competency፡- APPLY QUALITY STANDARDS

MODULE TITLE: APPLYING QUALITY STANDARDS
Module code: BUF ACB3 21 0812

2011 E.C

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LEARNING OUTCOMES
LO1 Assess own work
LO2 Assess quality of received articles
LO3 Record information
LO4 Study causes of quality deviations
LO5 Complete documentation

TABLE OF CONTENTS

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LO1 Assess own work.............................................................................................................................1

1.1 DEFINITIONS OF Quality.....................................................................................................................1

1.3 What Is A Standard?..........................................................................................................................2

1.4 Types of Standards............................................................................................................................2

1.5 Importance of the Quality Control...................................................................................................3

1.6 Why inspection?................................................................................................................................4

LO2 Assess quality of received articles...................................................................................................7

2.1 HUMAN FACTORS IN PRODUCT QUALITY..........................................................................................7

2.2 Quality Assurance..............................................................................................................................8

2.3 Steps in quality assurance cycle.........................................................................................................9

2.4 What do the laws say?.....................................................................................................................11

LO3 Record information.......................................................................................................................14

3.1 Housekeeping practices...................................................................................................................14

3.2 What is the purpose of workplace housekeeping?..........................................................................14

3.3 Kaizen Principles..............................................................................................................................19

LO4 Study cause of quality deviations..................................................................................................20

4.1 Health Hazard Evaluations...............................................................................................................20

4.2 RISK CONTROL AND INSURANCE.....................................................................................................21

4.3 THE DECISION TO RECALL................................................................................................................21

LO5 Complete documentation..............................................................................................................23

5.1 ALTERNATIVES TO A RECALL............................................................................................................23

5.2 Drafts of Communications Documents............................................................................................25

5.3 Disseminating the Information........................................................................................................25

5.4 Overseeing Product Disposition.......................................................................................................26

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LO1 Assess own work
1.1 Introduction to the module
1.2 Checking complete work with workplace standards
1.3 Completing work activities
1.4 Identifying and isolating final products with company policies and procedures
1.5 Recording and reporting faults and causes

1.1 DEFINITIONS OF Quality

INTRODUCTION
To the wider society quality is smartness and how good something is. This may be a service e.g.
canteen service or a product e g. Wrist watch. A person's judgment about a service or product
depends on what he expects of it or from it.
If a product fulfils the customer’s expectations, the customer will be pleased and consider that
the product is of acceptable or even high quality.
If his or her expectations are not fulfilled, the customer will consider that the product is of low
quality. This means that the quality of a product may be defined as “its ability to fulfill the
customer’s needs and expectations”.
Quality needs to be defined firstly in terms of parameters or characteristics, which vary from
product to product. For example, for a mechanical or electronic product these are performance,
reliability, safety and appearance.
For pharmaceutical products, parameters such as physical and chemical characteristics,
medicinal effect, toxicity, taste and shelf life may be important. For a food product they will
include taste, nutritional properties, texture, and shelf life and so on.
The word “Quality” is often used, but not often defined. You will find a variety of usages in any
dictionary but, for our purposes, a “degree of excellence” is the closest.
Some of the words used to describe quality are:
 Beautiful or attractive
 Durable
 Meeting standards

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  Healthy
 Value for money
Although different words are used to explain quality, we would define it as the extent to which a
product or service satisfies a person or a group i.e. how much satisfaction the person gets from
the service.

1.3 What Is A Standard?

The term standard is used very often but its meaning is not understood by most people.
A Standard is a statement of expected level of quality. It states clearly the inputs required
delivering a service, how things should be done (process) and what the output or outcome should
be. When we compare what is expected in the standards to what we do, we shall be able to
identify any quality gaps and then make plans to improve upon it.

1.4 Types of Standards

In carrying out any health activity there are three stages that are followed. We need inputs
(resources), we should also define clearly how things are going to be done (processes) and know
what results to expect (outcome). Standards must therefore be set for each of the three areas.
I Input Standards
Input or structure standards define the resources that must be supplied for the activities to
be carried out e.g., the physical structure, people, equipment and materials.
II Process Standards
Process standards describe the tasks or steps that must be carried out until the activity is
completed. In the example of outpatient services, the steps include, registration,
III Output/ Outcome Standards
Output/ Outcome standards describe the outputs or results of the activities carried out.
Generally Standards are used to:
 Define quality
 Determine, inputs, processes and outcomes, and
 Develop indicators to monitor quality.
Fixing product specifications

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A specification is the minimum requirement according to which a producer or service provider
makes and delivers the product and service to the customer. In setting specification limits, the
following should be considered:
 The user’s and/or customer’s needs
 Requirements relating to product safety and health hazards provided for in the
statutory and regulatory requirements
 Requirements provided for in national and/or international standards
 The competitor’s product specifications, in order to gain marketing advantages
In designing the product, the capacity of processes and machines should be kept in mind.
It is also necessary to maintain a balance between cost and value realization. The clearer
the specification, the better the possibility of creating and delivering quality products

1.5 Importance of the Quality Control

1 Principles of Quality Control
The following actions should be carried out in principle to realize effective QC:
 Analyze the present situation and identify the problem;
 Make a plan to address the problem;
 Implement the plan to eliminate the problem; and
 Review these sets of action to complete the quality control.
2. How to Implement Quality Improvement Measures
Quality improvement is a corporate goal and as such it should stem from the top most
management level. And as previously stated, this goal should be communicated to all
corporate divisions. In order to achieve optimum level of quality improvement, the
following steps should be considered: first is the necessary.

1.6 Why inspection?

By “inspection” it is usually meant that, at certain stages in the course of production, a
comparison is made between what has actually been produced and what should have been
produced. The standard of reference may be a specification, drawing or a visual quality standard.

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The check made must be appropriate to the job and must be made with suitable measuring
instruments. Inspectors should not waste time checking things that do not matter or fail to do a
check that is important.
Things that is unlikely to go wrong need little checking and those which are difficult to hold
within limits will need a considerable amount of attention. It is a misconception that the
inspector alone is responsible for quality.
Quality results from a combination of quality of the original designs, the methods, equipment
and materials used and the skill and care of the operator. In spite of these, if the job is still
wrong, no amount of inspection will put it right.
Different forms of inspection
According to production flow, the inspection may be divided into:
 Incoming inspection
 In-process inspection
 Final inspection
 Incoming inspection
Incoming inspection concerns goods upon delivery from vendors and/or suppliers. It
consists of inspection of raw materials, components, sub-assemblies and so on.
The aim of incoming inspection is to prevent goods that do not fulfill the quality
requirements from entering the production process. Incoming inspection is one of the
following steps in the control of the quality of supplies:
 A buying specification is prepared, setting out exactly what quality of material
has to be obtained;
 Possible suppliers are checked for their ability and willingness to provide this
quality. This is called “vendor appraisal” or “supplier evaluation”;
 If the results of the vendor appraisal are satisfactory, then the supplier is placed
on an approved list and purchase orders are placed when goods are required;
 When goods are received, they are subjected to some form of goods inward
inspection;

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  The results of the inspection are used to give each supplier a numerical rating,
showing how satisfactory or otherwise his suppliers are. This is called “vendor
rating”;
 The results at every stage are monitored and steps taken to improve or
discontinue unsatisfactory suppliers.
In-process inspection
In-process inspection aims to prevent products of unacceptable quality from being
manufactured. It provides data for making decisions on the product (accept or re work or
reject), as well as on the process (run or stop).
In-process inspection can take the form of:
 First-piece inspection
 Patrol inspection
 Operator inspection
 Last-piece inspection
 Stage inspection
Whenever a production run is started, it is prudent to check the first piece, the first
assembly and so on before the main run commences. Many faults can be detected by
checking the first piece off and this can prevent the whole batch from going wrong.
For example:
First-piece inspection can check whether the machine, jigs, fixtures, moulds, temperature
and so on are correctly set up;
First-piece inspection can discover whether the operator has fully understood his or her
instructions;
First-piece inspection can also identify any discrepancies between the drawing and the
quality plan, which can be investigated to avoid any further damage. While first-off
inspection ensures that the job starts correctly, the purpose of patrol inspection is to help
the operator to make the whole run correctly. From time to time, the patrol inspector
visits the machine or operator and if the quality of the sample checked during the visit is
wrong on any point, then this must be corrected as quickly as possible.

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 If an operator goes wrong, he or she should be told quickly. The operator should be
encouraged to regard the inspector as a friend assisting him in the task of keeping
defective work to a minimum.
Operator inspection means that instead of the inspector, the operator carries out the
inspection at a predetermined time during manufacturing.
Last-piece inspection is carried out on the last item manufactured in the lot. This allows
action to be taken to rectify faults in the machine and/or tools before beginning the next
lot. If these faults are only detected when the next lot has started, there will be a risk of
production delays.
Stage inspection involves inspection of products after every operation or group of
operations. Stage inspection points are located on the shop floor itself, where components
are tendered for inspection. Jobs found to be unacceptable are returned for rectification if
they are rectifiable, otherwise they are scrapped.
Final inspection
Final inspection and/or testing is done after manufacture has been completed, with the
object of making sure that the goods concerned are satisfactory for dispatch to the
customer or maybe to another department for the next operation.
Based on the product specifications, inspection instructions are prepared that lay down
the details of the tests to be carried out, the measuring instruments or test equipment to be
used and the criteria for deciding acceptance of the product with respect to each
characteristic.
Inspection instructions should also include details of the sampling plan such as size of
sample and the criteria of acceptance to be followed. Measuring instruments or test
equipment used for inspection should be calibrated periodically to verify their accuracy.

It is necessary to exercise suitable control over the movement of the product through the
inspection area in order to avoid a mix-up of accepted and rejected products. Ways to
exercise such control include:

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  Provision of clear labels (preferably of different colours) for products awaiting
inspection, accepted products, rejected products, products on hold awaiting
the results of tests and/or inspection and so on;
 Separation of accepted and rejected products;
 Review of rejected products for rectification or repair or for sale as seconds;
 The accepted product should only be released to the next process or to the
customer by a person who is authorized to do so.

LO2 Assess quality of received articles

2.1 Chatting materials articles and final products with workplace procedures
2.2 Measuring materials articles and products with workplace procedures
2.3 Identifying and correcting actions

2.1 HUMAN FACTORS IN PRODUCT QUALITY

It is commonly believed that most quality problems are caused primarily by lack of interest or
care on the part of the worker in the production department. However, it is usually not the
worker who can be blamed for this, since the conditions necessary to carry out the work correctly
often do not exist.
For example, instructions may be inadequate, the incoming material may be defective, the
machines may not be capable of producing goods of the required quality, and proper conditions
for conducting inspection of the product are not given to the workers and so on. Unfortunately
the worker has no control over these factors, but they may lead to defective work.
Thus 85 per cent of problems come under management control, whereas 15 per cent are under
worker control. Here too the worker can only be held responsible for the defects if:
 He or she knows what he or she is supposed to do;
 He or she knows the result of his or her own work;
 He or she has the means to influence the result.
The principal objectives of national food control systems are:
 Protecting public health by reducing the risk of food borne illness;
 Protecting consumers from unsanitary, unwholesome, mislabeled or adulterated food;
and

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  Contributing to economic development by maintaining consumer confidence in the food
system and providing a sound regulatory foundation for domestic and international trade
in food.

2.2 Quality Assurance

Is a set of activities that are planned for, carried out systematically or in an orderly manner and continuously to
improve quality of care?
It involves:
I the setting of standards;
II Monitoring to see if there is a gap between what is being done now and what is
expected; and addressing the gap on a regular basis (quality improvement).
There are five basic principles of quality assurance.
1. Quality Assurance is oriented towards meeting the needs and expectations of our customer
2. Quality Assurance focuses on systems and processes
3. Quality Assurance uses data to analyze service delivery
4. Quality Assurance encourages the use of teams in problem solving and quality improvement
5. Quality Assurance uses effective communication to improve Service delivery

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2.3 Steps in quality assurance cycle

1. Plan for Quality

We do planning in our everyday lives and in our facilities also. It is equally important to plan for
QA. Planning for quality is not an individual task but should be done by the whole QA team. It is
the task of this team to carefully plan activities that will facilitate the implementation of QA
activities in your facility. A budget should be prepared with the plans so that resources are
committed for quality assurance. The activities should be well organized, systematically carried
out and properly coordinated.
2. Review Standards
We need standards to check whether our activities meet client and professional expectations.
Standards are usually set at the national level but can be adapted for the lower levels. Protocols
and Guidelines can also help us to improve the quality of our services. Make a list of some of the
guidelines and protocols available at your facility.

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 3. Communicate Standards
Communication plays a very important role in QA. Whatever decision the team takes must be
well understood by all members and properly communicated to other staff. It is important to
communicate these standards set by the facility to all members of staff. For example all
prescribers in the facility should know about existing guidelines and protocols and comply
accordingly.
Each facility has its own effective way to communicate information to the staff. Examples
include meetings and durbars. What other examples do you have?
4. Monitor the Use of Standards
Once we have our standards, protocols and guidelines in place, we then monitor to see whether
we are adhering to them or not. For example, we can always check to see whether the
temperature is taken and recorded for malaria cases. The main aim of monitoring is to check
whether or not we are complying with standards.
5. Identify and Prioritize Problems
In our facilities, some of the problem areas are related to patient satisfaction, poor prescription
habits, infection control practices etc. Since we cannot solve all the problems at the same time,
there will be the need to prioritize.
We can determine the priority problem areas as well as opportunities for improvement. It may be
helpful to first select the simple ones that we have resources to solve. Once we see results of our
activities, we are encouraged to do more.
6. Define the Problem
Once the problem areas have been identified, we try to define them. We state them as problems.
What does this mean? Consider the following two statements about the state
7. Analyze the Problem
Every problem has got its underlying causes. We therefore analyze to find the root causes to the
problem. Simple methods for problem analysis include Brainstorming, But Why and Tree
diagram.
8. Evaluate.
At the end of the agreed period we check to see whether we have achieved our goal.
9. Suggest/Develop Solutions

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After analyzing the problem, the team should suggest ways of correcting the problem. Again,
this can be done through brainstorming to gather a lot of possible solutions. You can also find
out how other facilities have addressed similar problems.
Some problems are easy to solve while others are difficult. The solution you choose should be
practicable and within your available resources (money, material and human)
Once you get to the root causes, it becomes easy to suggest possible solution. Usually the root
causes and the suggested solutions are like the two sides of a coin. In the above example, the
suggested solution is to provide dustbins.
10. Implement Solution.
First develop action plan. The action plan spells out the activities to be undertaken based on the
solutions, persons responsible, time frame for each activity, resources required, expected output
and how monitored.
It is helpful to assign people to specific tasks even though we all work on the problem as a team.
The person responsible should be clear about the task and the time to report to the team.
Remember the saying that everybody's business is nobody's business. Always remember to
make people responsible!

2.4 What do the laws say?

This manual cannot begin to thoroughly cover state and local food safety ordinances, since they
vary widely. However, most follow the basic guidelines of the federal food safety laws.
The big difference is that, in most jurisdictions, health department personnel have the right to
unannounced inspections of food facilities, to check the following items and conditions:
• Food protection—whether containers are properly stored, sealed an labeled.
• Proper food temperatures during storage, preparation, holding and serving.
• Safe handling of food and ice; correct use and sanitation of utensils and food contact surfaces
to prevent cross-contamination.
• Hygiene practices of employees, and restriction of any infected or ill employee from working
with food.
• Construction and installation of equipment for maximum safety.
• Adequate ventilation, especially in cooking and dishwashing areas.

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• Safe water temperatures of dishwashing machines.
 Safe water sources; adequate hot and cold running water.
• Proper disposal of sewage and wastewater.
• Adequate numbers of toilets sinks and separate hand-washing sinks.
• Clean, covered interior trash receptacles, and exterior dumpster facilities that are properly
constructed and enclosed.
• Insect, rodent and animal control (with written records available for inspection).
• Floors, walls, ceilings washable and in good repair; working floor drains in food preparation
areas; lighting adequate and fixtures shielded in case of bulb breakage.
• Toxic items (like cleaning materials) properly labeled and stored.
• Proper storage of clean and soiled linens, dishtowels, etc.
• A no-smoking policy, or designated smoking areas, which must be clearly marked.
• If a grease trap is used, its clean-out records must be available to inspectors.
• Emergency procedures (Heimlich maneuver, etc.) must be posted prominently in many food
ser-vice work areas, along with any permits the city, county or state requires of the particular
type of business
By law, the recall communication MUST include the following details:
• The complete identity of the product, along with labels, brand name and code number
information.
• That the product is being recalled.
• That “further distribution or use of any remaining product should cease immediately.”
• That this customer should notify any of its own customers, down the line, if they
received any of the products.
• Specific instructions for what to do with the product.
It should also include a “ready means” for the customer to report back to the company.
The FDA’s suggestions are:
• A self-addressed, postage-paid postcard, or...
• A phone number for customers to call, collect or toll-free

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The lead regulatory agency contacts the company to gather the following information.
Depending on the circumstances, the lead agency may already have some of this information on
file before contacting the firm:
1. Product Identity
• Product name, including all brand names and generic names.
• Product code numbers (e.g., lot/unit numbers, expiration dates, use-by dates, UPC codes).
• Product description (e.g., powder, liquid, ready-to-eat, expected shelf-life, packaging type and
size).
2. Manufacturer Identity
• Firm name, address, city, state, zip code.
• Most responsible individual for firm: name, title, phone, fax, email address.
• Recall contact: name, title, phone, fax, email address.
• Contact for the public: name, title, phone, fax, email address.
3. Reason for the recall
• Explanation of cause of problem and date or time it occurred.
• Explanation of how and when the problem was discovered.
• Explain whether the problem affects all products in the lot or quantity being recalled or
only a portion of the products being recalled. (If it’s a portion, provide as accurate a
quantity as possible).
• If firm received a positive microbiological sample laboratory result, get a copy of the
confirmed result.
• If firm received complaints associated with the problem, they must provide date(s) of
complaint(s), with descriptions that include details of injury or illness, lot numbers, code
dates, etc.
• If recall is due to presence of a foreign object, describe the size, composition, hardness
and/or sharpness of the object.
• If recall is due to presence of a chemical contaminant, explain level of contamination,
and provide labeling, list of ingredients and the Material Safety Data Sheet for the
contaminant.

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 • If recall is the result of a labeling issue, the company must provide and identify the
correct and incorrect label(s), description and formulation.
4. Firm’s assessment of the health risk associated with the product deficiency, including
any supporting data or information.
5. Volume of product being recall
• Total quantity produced.
• Date(s) produced.
• Quantity distributed.
• Quantity on hold by recalling firm and its distribution centers.
• Description of product quarantine procedures and conditions.
• Estimate amount of product remaining in the marketplace at: distributor level, retail
level, and consumer level.

LO3 Record information

3.1 Recording basic information in the quality performance
3.2 Maintaining records of work quality

3.1 Housekeeping practices

Effective housekeeping can eliminate some workplace hazards and help get a job done safely and
properly. Poor housekeeping can frequently contribute to accidents by hiding hazards that cause
injuries. If the sight of paper, debris, clutter and spills is accepted as normal, then other more
serious health and safety hazards may be taken for granted.

Housekeeping is not just cleanliness. It includes keeping work areas neat and orderly;
maintaining halls and floors free of slip and trip hazards; and removing of waste materials (e.g.,
paper, cardboard) and other fire hazards from work areas. It also requires paying attention to
important details such as the layout of the whole workplace, aisle marking, the adequacy of
storage facilities, and maintenance. Good housekeeping is also a basic part of accident and fire
prevention.

Effective housekeeping is an ongoing operation: it is not a hit-and-miss cleanup done

occasionally. Periodic "panic" cleanups are costly and ineffective in reducing accidents.

3.2 What is the purpose of workplace housekeeping?

Poor housekeeping can be a cause of accidents, such as:

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  tripping over loose objects on floors, stairs and platforms
 being hit by falling objects
 slipping on greasy, wet or dirty surfaces
 striking against projecting, poorly stacked items or misplaced material
 cutting, puncturing, or tearing the skin of hands or other parts of the body on projecting
nails, wire or steel strapping

To avoid these hazards, a workplace must "maintain" order throughout a workday. Although this
effort requires a great deal of management and planning, the benefits are many.

What are some benefits of good housekeeping practices?

Effective housekeeping results in:

 reduced handling to ease the flow of materials

 fewer tripping and slipping accidents in clutter-free and spill-free work areas
 decreased fire hazards
 lower worker exposures to hazardous substances (e.g. dusts, vapours)
 better control of tools and materials, including inventory and supplies
 more efficient equipment cleanup and maintenance
 better hygienic conditions leading to improved health
 more effective use of space
 reduced property damage by improving preventive maintenance
 less janitorial work
 improved morale
 improved productivity (tools and materials will be easy to find)

How do I plan a good housekeeping program?

A good housekeeping program plans and manages the orderly storage and movement of
materials from point of entry to exit. It includes a material flow plan to ensure minimal handling.
The plan also ensures that work areas are not used as storage areas by having workers move
materials to and from work areas as needed. Part of the plan could include investing in extra bins
and more frequent disposal.

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Housekeeping order is "maintained" not "achieved." Cleaning and organization must be done
regularly, not just at the end of the shift. Integrating housekeeping into jobs can help ensure this
is done. A good housekeeping program identifies and assigns responsibilities for the following:

 clean up during the shift

 day-to-day cleanup
 waste disposal
 removal of unused materials
 inspection to ensure cleanup is complete

Do not forget out-of-the-way places such as shelves, basements, sheds, and boiler rooms that
would otherwise be overlooked. The orderly arrangement of operations, tools, equipment and
supplies is an important part of a good housekeeping program.

The final addition to any housekeeping program is inspection. It is the only way to check for
deficiencies in the program so that changes can be made.

What are the elements of an effective housekeeping program?

Dust and Dirt Removal

In some jobs, enclosures and exhaust ventilation systems may fail to collect dust, dirt and chips
adequately. Vacuum cleaners are suitable for removing light dust and dirt. Industrial models
have special fittings for cleaning walls, ceilings, ledges, machinery, and other hard-to-reach
places where dust and dirt may accumulate.

Special-purpose vacuums are useful for removing hazardous substances. For example, vacuum
cleaners fitted with HEPA (high efficiency particulate air) filters may be used to capture fine
particles of asbestos or fiberglass.

Dampening (wetting) floors or using sweeping compounds before sweeping reduces the amount
of airborne dust. The dust and grime that collect in places like shelves, piping, conduits, light
fixtures, reflectors, windows, cupboards and lockers may require manual cleaning.

Compressed air should not be used for removing dust, dirt or chips from equipment or work
surfaces.

Employee Facilities

Employee facilities need to be adequate, clean and well maintained. Lockers are necessary for
storing employees' personal belongings. Washroom facilities require cleaning once or more each
shift. They also need to have a good supply of soap, towels plus disinfectants, if needed.

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If workers are using hazardous materials, employee facilities should provide special precautions
such as showers, washing facilities and change rooms. Some facilities may require two locker
rooms with showers between. Using such double locker rooms allows workers to shower off
workplace contaminants and prevents them from contaminating their "street clothes" by keeping
their work clothes separated from the clothing that they wear home.

Smoking, eating or drinking in the work area should be prohibited where toxic materials are
handled. The eating area should be separate from the work area and should be cleaned properly
each shift.

Surfaces

Floors: Poor floor conditions are a leading cause of accidents so cleaning up spilled oil and other
liquids at once is important. Allowing chips, shavings and dust to accumulate can also cause
accidents. Trapping chips, shavings and dust before they reach the floor or cleaning them up
regularly can prevent their accumulation. Areas that cannot be cleaned continuously, such as
entrance ways, should have anti-slip flooring. Keeping floors in good order also means replacing
any worn, ripped, or damaged flooring that poses a tripping hazard.

Walls: Light-coloured walls reflect light while dirty or dark-coloured walls absorb light.
Contrasting colours warn of physical hazards and mark obstructions such as pillars. Paint can
highlight railings, guards and other safety equipment, but should never be used as a substitute for
guarding. The program should outline the regulations and standards for colours.

Maintain Light Fixtures

Dirty light fixtures reduce essential light levels. Clean light fixtures can improve lighting
efficiency significantly.

Aisles and Stairways

Aisles should be wide enough to accommodate people and vehicles comfortably and safely.
Aisle space allows for the movement of people, products and materials. Warning signs and
mirrors can improve sight-lines in blind corners. Arranging aisles properly encourages people to
use them so that they do not take shortcuts through hazardous areas.

Keeping aisles and stairways clear is important. They should not be used for temporary
"overflow" or "bottleneck" storage. Stairways and aisles also require adequate lighting.

Spill Control

The best way to control spills is to stop them before they happen. Regularly cleaning and
maintaining machines and equipment is one way. Another is to use drip pans and guards where
possible spills might occur. When spills do occur, it is important to clean them up immediately.

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Absorbent materials are useful for wiping up greasy, oily or other liquid spills. Used absorbents
must be disposed of properly and safely.

Tools and Equipment

Tool housekeeping is very important, whether in the tool room, on the rack, in the yard, or on the
bench. Tools require suitable fixtures with marked locations to provide orderly arrangement,
both in the tool room and near the work bench. Returning them promptly after use reduces the
chance of being misplaced or lost. Workers should regularly inspect, clean and repair all tools
and take any damaged or worn tools out of service.

Maintenance

The maintenance of buildings and equipment may be the most important element of good
housekeeping. Maintenance involves keeping buildings, equipment and machinery in safe,
efficient working order and in good repair. This includes maintaining sanitary facilities and
regularly painting and cleaning walls. Broken windows, damaged doors, defective plumbing and
broken floor surfaces can make a workplace look neglected; these conditions can cause accidents
and affect work practices. So it is important to replace or fix broken or damaged items as quickly
as possible. A good maintenance program provides for the inspection, maintenance, upkeep and
repair of tools, equipment, machines and processes.

Waste Disposal

The regular collection, grading and sorting of scrap contribute to good housekeeping practices. It
also makes it possible to separate materials that can be recycled from those going to waste
disposal facilities.

Allowing material to build up on the floor wastes time and energy since additional time is
required for cleaning it up. Placing scrap containers near where the waste is produced encourages
orderly waste disposal and makes collection easier. All waste receptacles should be clearly
labelled (e.g., recyclable glass, plastic, scrap metal, etc.).

Storage

Good organization of stored materials is essential for overcoming material storage problems
whether on a temporary or permanent basis. There will also be fewer strain injuries if the amount
of handling is reduced, especially if less manual materials handling is required. The location of
the stockpiles should not interfere with work but they should still be readily available when
required. Stored materials should allow at least one metre (or about three feet) of clear space
under sprinkler heads.

Stacking cartons and drums on a firm foundation and cross tying them, where necessary, reduces
the chance of their movement. Stored materials should not obstruct aisles, stairs, exits, fire

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equipment, emergency eyewash fountains, emergency showers, or first aid stations. All storage
areas should be clearly marked.

Flammable, combustible, toxic and other hazardous materials should be stored in approved
containers in designated areas that are appropriate for the different hazards that they pose.
Storage of materials should meet all requirements specified in the fire codes and the regulations
of environmental and occupational health and safety agencies in your jurisdiction

3.3 Kaizen Principles

Kaizen is the practice of continuous improvement. Kaizen was originally introduced to the West
by Masaaki Imai in his book Kaizen: The Key to Japan’s Competitive Success in 1986. Today
kaizen is recognized worldwide as an important pillar of an organization’s long-term competitive
strategy. Kaizen is continuous improvement that is based on certain guiding principles:

 Good processes bring good results

 Go see for yourself to grasp the current situation
 Speak with data, manage by facts
 Take action to contain and correct root causes of problems
 Work as a team
 Kaizen is everybody’s business
 And much more!

One of the most notable features of kaizen is that big results come from many small changes
accumulated over time. However this has been misunderstood to mean that kaizen equals small
changes. In fact, kaizen means everyone involved in making improvements. While the majority
of changes may be small, the greatest impact may be kaizen that are led by senior management
as transformational projects, or by cross-functional teams as kaizen events.

5S of Kaizen

5S is a productivity method whose name is derived from the five first letters of Japanese words:
Seiri, Seiton, Seiso, Seiketsu and Shitsuke. The method was originally intended to organize a
workspace for efficiency. Let’s examine each ‘S’ and determine what it means.

 Seiri - Sorting. Keep the necessary in work area, dispose or keep in a

distant storage area less frequently used items, discard unneeded items.
 Seiton - Systematic Arrangement for the most efficient and effective
retrieval. There should be a place for everything and everything should be
in its place. The place for each item should be clearly labeled or
demarcated. Items should be arranged in a manner that promotes efficient

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 workflow, with equipment used most often being the most easily
accessible. Workers should not have to bend repetitively to access
materials.
 Seiso – Shining. Clean the workspace and all equipment, and keep it clean,
tidy and organized. After the first thorough cleaning when implementing
5S, daily follow-up cleaning is necessary in order to sustain this
improvement. A “Shining” work environment will lead to great efficiency
gains.
 Seiketsu - Standardizing. Work practices should be consistent and
standardized. Work stations for a particular job should be identical. All
employees doing the same job should be able to work in any station with
the same tools that are in the same location in every station. Everyone
should know exactly their responsibilities.
 Shitsuke – Sustaining. Once the previous 4 S's have been established, they
become the new way to operate. Maintain focus on this new way and do
not allow a gradual decline back to the old ways. The effect of continuous
improvement (Kaizen) leads to less waste, better quality and faster lead
times.

LO4 Study cause of quality deviations

4.1 Investigating and reporting causes of devastations
4.2 Recommending suitable preventive actions on workplace standards

4.1 Health Hazard Evaluations

Once the data has been collected, the Health Hazard Evaluation Committee can be
assembled by the lead agency to review the documentation and decide on a recall
classification. This evaluation takes into account, but is not limited to, the following
factors:
 The nature of the violation or defect—adulterated product, misbranded
product, improperly labeled product, etc.
 Whether any illnesses or injuries have already occurred from the use of
the product.
 The likelihood that illnesses or injuries may result.
 Whether any existing conditions could contribute to a situation that could
expose humans to a health hazard, and the types of illnesses or injuries
that may result.

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  An assessment of the hazard to particular segments of the population—
children, elderly, expectant mothers, persons with compromised immune
systems, etc.—and the degree of seriousness of this hazard to these
specific population segments.
 An assessment of both immediate and long-term consequences of the
hazard

4.2 RISK CONTROL AND INSURANCE

Now you should have a very thorough idea of what might happen, even if it never does.
When you’ve identified these risks, you can decide how to reduce or eliminate them.
Prioritize the list—as high, medium or low risk—and tackle the highest risks first. You
are looking for effective risk control measures.
An “effective” measure is one that reduces ANY of these three factors:
• The probability of a problem.
• The severity of a problem.
• The exposure to a problem.

4.3 THE DECISION TO RECALL

Ironically, the two biggest questions in a product crisis don’t seem as complex as they
actually are:
1. Should there be a recall in the first place?
2. What should be recalled?
Even when health inspectors are telling you they have some serious concerns about one
of your products, a recall notification will not necessarily follow. Remember, the FDA
and FSIS prefer that the action be voluntary.
This means a responsible company will determine in advance, as much as possible,
under what circumstances a recall will take place. An agency may not have been the
source of the information in the first place—it may be problems that your own
employees, or consumer complaints, have brought to your attention.

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 A product should be recalled if there is credible evidence that shows it has caused any
illness, due to suspected contamination or another unsafe condition. No matter what the
circumstances, the decision to recall must always be made quickly.
So, when a complaint first comes to your attention, you should be able to pinpoint the
source of the complaint or notification, and to confirm the credibility of that source.
1. If the information comes from health inspectors or a federal agency, listen carefully to
what they say.
2. Take notes. You have the right to ask for and/or expect:
• Courteous treatment.
• An explanation of the process or findings that linked this product to particular problems
or illnesses.
• A specific time period for the records they are requesting.
• A minimal number of individuals or agencies requesting the same information from
you.
• Access to supervisors or managers of the agency if a field investigator cannot answer
your questions.
• Copies of paperwork, from news releases to the agency’s inspections, lab reports, etc.
Ask if the inspector or agency is making a specific recommendation to recall, or any
other recommendations. You will usually receive these in writing, soon after the initial
telephone or personal con-tact. Tell them you will notify your Recall Team immediately
before a decision is made—then do it.
2. If the information comes from a member of the public who has called or written to
make a complaint:
• You should get as much information as possible from the complainant. This includes:
a) All contact information.
b) Exactly what they feel the problem is with the food (chemical taste, “off” odor,
allergic reaction, and object in the food).
c) Exact product details (name of product, size of package, code numbers, whether they
still have any of it left—in that container, or others like it that are unopened).
d) Details of how the product was stored and handled after purchase.

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 e) Name and address of the store where it was purchased, and date of purchase.
f) Date and time the product was consumed.
g) Amount of product that was consumed.
h) Has this person ever consumed this product before?
I) did others consume it too, and do they have the same complaint?
j) Names and ages of the people who are affected.
k) Symptoms, in the order that they appeared, and approximate time they began.
l) Name and contact information for any physician they may have consulted about this
incident.
m) Name and contact information of any other agency they may have contacted to report
this incident.
• Some experts say it is very important to cover yourself legally by asking the person to
fill out a form that lists everything they have eaten in the previous three days, and return
it to you. See a sample of this form, as well as a questionnaire for phone-in complaints, in
Appendix 1.
• Use this information to begin (or continue) your own, internal investigation and testing.
The second big question, about what should be recalled, refers to exactly which
product(s) are affected. The answer may be:
• Particular lots or batches.
• Items made between certain production dates.
• Items made at a certain plant.
• Items that contain a certain ingredient, often an allergen.
• Products that have been mislabeled.
• Items with faulty packaging.
• Products that may be contaminated

LO5 Complete documentation

5.1 Recording information on quality and other indictors of production performance
5.2 Recording all production processes and outcomes

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5.1 ALTERNATIVES TO A RECALL
A company’s first reaction is usually to try to limit a recall to include as small an amount
of product as possible, to minimize disruption, financial losses and negative publicity.
Government agencies will insist on scientifically valid reasons for this kind of limitation,
so be ready to justify your decision, whatever it is. Of course, there are other options
short of a recall.
They are:
Correction — an action taken to modify a product to cause it to conform to applicable
regulations so that it may remain in distribution. Corrective action includes repairing, re-
labeling or making an adjustment to a product. With agency approval, a product might
even be destroyed under the “Correction” banner.
Product withdrawal (or market withdrawal) – The act of removing a product from
distribution when it violates federal or state law in a minor or technical way (not posing a
health-related risk), or when it doesn’t meet the manufacturer’s own specifications or
quality standards, It does not include products that have been contaminated or
adulterated.
In a withdrawal, you can notify your consignees (usually wholesale distributors and
retailers) to remove certain products from distribution, and to replace them with new
stock that you provide.
You can have your own sales force or sales brokers perform the removal and replacement
duties.
Stock recovery — the act of removing a product from potential distribution before it has
left the direct control of the manufacturer. It may be in your own warehouse, or on
wholesalers’ shelves, but has not been released to the public. Your company simply
places a “hold” on the merchandise, so it does not leave your direct control.
Commodity Hold and Release – This system is unique to USDA commodity (bulk)
foods given to large foodservice customers, like school districts, which has a completely
different set of rules than other types of product retrievals.

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 A school district, for example, is notified to “hold” (stop using and isolate any remaining
stock) a product for up to 10 calendar days while the USDA investigates the claim that it
might be unsafe. It may be determined to be safe (and “released” for use), or it may be
recalled.
The State Distributing Agency that distributes commodity foods serves as the
clearinghouse for information during a hold-and-release investigation.

5.2 Drafts of Communications Documents

As facts are determined, the Recall Plan must specify who should be contacted and what
information should be dispersed. This includes everyone from employees, to consignees,
to state and federal authorities, to the news media.
It is absolutely critical that the team designates a single spokesperson who can handle
inquiries from the press and the public, to ensure that a consistent message is being
delivered. Your attorney should brief this person before speaking publicly, so as not to
say anything that might later turn out to be legally damaging.
With so much to disseminate and so little time, it is smart to have “sample documents”
ready, that can be easily adapted to the circumstances. You’ll find examples of some of
these in the appendices for this manual.
Always ask your attorney to read your document drafts before they are used!
a) A form for noting complaints and/or threats that come in by phone.
b) A telephone script for calling consignees (distributors, wholesalers, retailers) to inform
them of the recall.
c) A fax (that can either precede or follow) the initial phone call to consignees,
confirming the recall information.
d) A letter on company letterhead, restating the recall information and providing specific
details for destruction or return of the product.
e) A news release for newspapers, radio and/or television stations.
f) A Recall Effectiveness Check, which can be done by letter, phone or in person.

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 g) A Recall Status Report, which the FDA or FSIS will want to see. It is a written update
of progress during a recall. (See the “During a Recall” chapter for details on what it must
contain.)

5.3 Disseminating the Information

Also think about other groups and institutions that might need to know about recalls.
Anyone who might have received the food, or who might receive complaints or
questions, should be notified.
Depending on the product and the situation, this may include:
• Food banks
• State agencies
• Trade associations (for restaurants, caterers, etc.)
• Consumer groups
• Military bases
• School districts
• Hospitals, nursing homes, Senior Citizen Centers
• The state Medical Association

5.4 Overseeing Product Disposition

What to do with recalled product is a question that should be resolved jointly by the
agency and the recalling company. Remember that reconditioning is only an option if it
brings the product into compliance with the law. Methods may include:
• Cleaning
• Reprocessing
• Repackaging
• Relabeling
• Over stamping
• Sorting
• Segregating

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