UNIT 9 - QUALITY ASSURANCE

Total Quality Management, TQM, is a method by which management and employees can become involved in the continuous improvement of the production of goods and services. It is a combination of quality and management tools aimed at increasing business and reducing losses due to wasteful practices.

Total Quality Management (TQM) is a management approach that originated in the 1950s and has steadily become more popular since the early 1980s. Total Quality is a description of the culture, attitude and organization of a company that strives to provide customers with products and services that satisfy their needs. The culture requires quality in all aspects of the company’s operations, with processes being done right the first time and defects and waste eradicated from operations.

TQM is a method for reducing errors in production, increasing total production during a given time frame and giving customers greater satisfaction. Although slow to be adopted, TQM is today one of the cornerstones for modern manufacturing, distribution and retail sales businesses.

TQM is defined

As a management philosophy that seeks to integrate all organizational functions (marketing, finance, design, engineering, and production, customer service, etc.) to focus on meeting customer needs and organizational objectives.

The simple objective of TQM is “Do the right things, right the first time, every time.”

TQM is now becoming recognized as a generic management tool, just as applicable to service and public sector organizations. TQM is the foundation for activities, which include:

• Commitment by senior management and all employees
• Meeting customer requirements
• Reducing development cycle times
• Just in time/demand flow manufacturing
• Improvement teams
• Reducing product and service costs
• Systems to facilitate improvement
• Line management ownership
• Employee involvement and empowerment
• Recognition and celebration
• Challenging quantified goals and benchmarking
• Focus on processes/improvement plans
• Specific incorporation in strategic planning

Principles

Total Quality Management,” a term commonly used incorporation and business management. TQM is a customer-focused approach that involves several principles for effective business management and prevents defects and quality issues within a company. These principles include leadership, strategic planning, customer focus, analysis, human resources, process management and seeing business results.

1. Leadership 

Structuring your system of organized leadership within a business will enhance overall management and productivity within a company. Full commitment is needed at the top of the business hierarchy.

2. Strategic Planning

Having a focus and a strong perspective on quality in production and in work levels allows personnel at all ranks to constantly plan for improvements. Awareness of a desire for perfection in workplace operations and an emphasis on consistency, stability and steadiness will help to promote production processes for creating products and managing customer satisfaction. Strategic planning also encompasses quality control.

3. Customer & Market Focus

Understand how your marketing and personnel influence customer satisfaction. Customer and the satisfaction of the customer that makes your attempts worth the effort.

4. Information and Analysis

There should be time set aside to spend measuring business data and the continuity of the level of organization within the company. Information on how a business is performing can help to eradicate bad practices and favouritism. It is important to have a long-term goal for profits, production quotas and growth of the business that all members of the team understand, and to spend less time focused on the short term.

5. Human Resource Focus

Employing the people who will most carry your team toward an overall goal of customer satisfaction is key to the functioning of any business. Prevent problems before they occur by continually evaluating personnel and processes within the company. Evaluation will keep the company from investing resources and time into processes that cause errors and problematic wasted efforts

6. Process Management

Keeping a team focused on the functional operation of work systems and devising plans that help employees to be educated and well-trained in their particular fields will allow for the company to grow and flourish. Have a definitive mission for the company and aim for the continual satisfaction of customers while maintaining motivation and satisfaction in team members.

7. Business Results

Improving different areas of business models will help companies to see overall improvement in customer service within the company, product performance, finances within the business and customer satisfaction Other expected benefits of streamlining efficiency in the workplace include improved organization, better feedback, better performance standards, increased economic growth, increased customer loyalty, brand recognition, improved products and better-offered services.

Time quality work is the first key principle of TQM theory. The principle philosophy for this is, “If we do not have the time to do things right the first time, how will we have the time to do it right a second time?”

RELEVANCE OF MICROBIOLOGICAL STANDARDS FOR FOOD SAFETY

• A microbiological standard is a microbiological criterion that is a part of a law, ordinance, or administrative regulation. 
• A standard is a mandatory criterion. 
• Failure to comply with it constitutes violation of the law, ordinance, or regulation and will be subject to the enforcement policy of the regulatory agency having jurisdiction.

Purposes

Microbiological standards as described above may be used to assess:

1. the safety of a food,

2. adherence to good manufacturing practices,

3. the utility (suitability) of a food or ingredient for a particular purpose, and

4. the keeping quality (shelf-life) of certain perishable foods.

RISK ASSESSMENT

A risk assessment is simply a careful examination of what, in your work, could cause harm to people, so that you can weigh up whether you have taken enough precautions or should do more to prevent harm.

Risk assessment is defined for the purposes of the Codex Alimentarius Commission as

“A scientifically based process consisting of the following steps:

(i) hazard identification,

(ii) hazard characterization,

(iii) exposure assessment, and

(iv) risk characterization.”

Hazard identification is “The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods.”

Hazard characterization is “The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. 

Exposure assessment is “The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant.”

Risk characterization is “The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment.” Hazard identification, hazard characterization, exposure assessment will help to know the adverse health effect.

HACCP

Hazard Analysis and Critical Control Point (HACCP) is an internationally recognized system for reducing the risk of safety hazards in food.

Hazard Analysis and Critical Control Points or HACCP is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level.

HACCP Basic Principles:-

HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles:

Principle 1: Conduct a hazard analysis.

The application of this principle involves listing the steps in the process and identifying where significant hazards are likely to occur. The HACCP team will focus on hazards that can be prevented, eliminated or controlled by the HACCP plan. A justification for including or excluding the hazard is reported and possible control measures are identified.

Principle 2: Determine the critical control points (CCPs).

A critical control point (CCP) is a point, step or procedure at which control can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels. The HACCP team will use a CCP decision tree to help identify the critical control points in the process. A critical control point may control more that one food safety hazard or in some cases more than one CCP is needed to control a single hazard. The number of CCP’s needed depends on the processing steps and the control needed to assure food safety.

Principle 3: Establish critical limits.

A critical limit (CL) is the maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate, or reduce to an acceptable level the occurrence of a food safety hazard. The critical limit is usually a measure such as time, temperature, water activity (Aw), pH, weight, or some other measure that is based on scientific literature and/or regulatory standards.

Principle 4: Establish monitoring procedures.

The HACCP team will describe monitoring procedures for the measurement of the critical limit at each critical control point. Monitoring procedures should describe how the measurement will be taken when the measurement is taken, who is responsible for the measurement and how frequently the measurement is taken during production.

Principle 5: Establish corrective actions.

Corrective actions are the procedures that are followed when a deviation in a critical limit occurs. The HACCP team will identify the steps that will be taken to prevent potentially hazardous food from entering the food chain and the steps that are needed to correct the process. This usually includes identification of the problems and the steps taken to assure that the problem will not occur again.

Principle 6: Establish verification procedures.

Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. The HACCP team may identify activities such as auditing of CCP’s, record review, prior shipment review, instrument calibration and product testing as part of the verification activities.

Principle 7: Establish record-keeping and documentation procedures.

A key component of the HACCP plan is recording information that can be used to prove that the food was produced safely. The records also need to include information about the HACCP plan. A record should include information on the HACCP Team, product description, flow diagrams, the hazard analysis, the CCP’s identified, Critical Limits, Monitoring System, Corrective Actions, Recordkeeping Procedures, and Verification Procedures.

Implementing HACCP in 12 steps:-

1. Assemble a HACCP team with the appropriate product-specific knowledge and expertise to develop an effective Food Safety Plan. The team should comprise individuals familiar with all aspects of the production process, plus specialists with expertise in specific areas, such as engineering or microbiology. It may be necessary to use external sources of expertise in some cases.
2. Describe the product in full detail, including composition, physical/chemical structure, microbial/static treatments, packaging, storage conditions, and distribution methods.
3. Identify the intended/expected use of the product by the end user. It is also important to identify the consumer target groups. Vulnerable groups, such as children or the elderly, may need to be considered specifically.
4. Construct a flow diagram that provides an accurate representation of each step in the manufacturing process—from raw materials to end product—and may include details of the factory and equipment layout, ingredient specifications, features of equipment design, time/temperature data, cleaning and hygiene procedures, and storage conditions.
5. Perform an on-site confirmation of the flow diagram to confirm that it is aligned with actual operations. The operation should be observed at each stage and any discrepancies between the diagram and normal practice should be recorded and amended. It is essential that the flow diagram is accurate since the hazard analysis and identification of Critical Control Points (CCPs) rely on the data it contains.
6. Conduct a hazard analysis for each process steps to identify any biological, chemical, or physical hazards. This assessment also includes rating the hazard using a risk matrix, determining if the hazard is likely to occur, and identifying the preventive controls for the process step.
7. Determine Critical Control Points (CCPs)—those areas where previously identified hazards may be eliminated. The final HACCP Plan will focus on the control and monitoring of the process at these points.
8. Establish critical limits and develop processes that limit risk at CCPs. More than one critical limit may be defined for a single step. Criteria used to set critical limits must be measurable and include rating and ranking of hazards for each step of the flowchart.
9. Monitor CCPs and develop processes for ensuring that critical limits are followed. Monitoring procedures must be able to detect loss of control at the CCP and should provide this information in time to make appropriate adjustments so that control of the process is regained before critical limits are exceeded. Where possible, process adjustments should be made when monitoring results indicate a trend towards a loss of control at a CCP.
10. Establish preplanned corrective actions to be taken for each CCP in the HACCP plan that can then be applied when the CCP is not under control. If monitoring indicates a deviation from the critical limits for a CCP, action (e.g., proper isolation and disposition of affected product) must be taken that will bring it back under control.
11. Establish procedures for verification to determine whether the HACCP system is working correctly. Verification procedures should include detailed reviews of all aspects of the HACCP system and its records. The documentation should confirm that CCPs are under control and should also indicate the nature and extent of any deviations from the critical limits and the corrective actions taken in each case.
12. Establish proper documentation and recordkeeping for all HACCP processes to ensure that the business can verify that controls are in place and are being properly maintained.