• ISO 9000 Quality Management Systems
• Total Quality Management (TQM)
• Table - Elements of TQM
• Table - Guiding principles of successful TQM
• Seven Principles of HACCP
• Table - FDA-specified standard methods for analysis of daily products
  

• Refinement in the presentation to make reading easy and elimination of general inauditable statements such as "consideration shall be given…". Changes have been effected in language to make things clearer, easier in understanding and more easily translatable in different languages.
• The present standard gave an impression that it was applicable to manufacturing situation though it was applied in organizations of different types and sizes, including the service sector. The new standard has no such association with manufacturing industries. It is a broad-based standard applicable to all sectors.
• In the new standards approach has changed from continuous improvement to continual improvement. Continuous improvement remained an implied approach to quality improvement in ISO 9000. However, the concept of continuous improvement is not sustainable, as a straight-line upward progression cannot be achieved. It has to be a designed improvement plan for product, process and system with carefully quantified increase within a stipulated time to continuously meet dynamic needs of customers. It is ladder improvement on identified parameters of quality or process.
  

Total Quality Management (TQM) (Pg 329)

It is defined as "that aspect of the overall management that determines and implements the quality policy and as such is the responsibility of top management." Thus, TQM is an organizational concern and not a domain of any specialist or specific function.

Table 5.2.1 Elements of TQM system (Pg 330)

Table 5.2.2 Guiding principles for successful TQM (Pg 330)

Seven Principles of HACCP (Pg 332)

The five preliminary steps serve as basis for seven principles for HACCP implementation, given below:

Principle 1 — Conduct Hazard Analysis: When conducting the hazard analysis, consideration must be given to the impact of raw materials, ingre-dients, manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, consumer populations at risk and epidemio-logical evidence relative to food safety.

Principle 2 — Determine Critical Control Points (CCPs): A critical control point is a point/step/procedure where a food safety hazard can be prevented, eliminated or reduced to acceptable levels.

Critical limits must be specified for each pre-ventive measure. In some cases more than one critical limit will be elaborated at a particular step.

Principle 3 — Establish Critical Limits for each CCP: A critical limit is the maximum or minimum value to which a physical, chemical or biological hazard must be controlled at its CCP to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard. The critical limits should be specified and validated (if possible) for critical control points.

The critical limits are normally fixed at tolerances given in the regulations, which have to be met or guided by process variations. There is no room for error before the product violates regulatory requirements. Therefore, process variation must be kept in mind while fixing the limit.

Principle 4 — Establish a Monitor System for Each CCP: The monitoring procedures must be able to detect loss of control at the CCP. Further, monitoring should ideally provide this information in time for corrective action to be taken to regain control of the process before there is a need to reject the product arises.

The CCP monitoring system would be effective if:

• Clearly identified personnel are made responsible for monitoring;
• Trained personnel are deployed for monitoring CCPs; and
• It is ensured that personnel understand purpose and importance of monitoring.

Principle 5 — Establish Corrective Actions: Corrective actions must ensure that the CCP has been brought back under control before the deviation leads to a safety hazard. Actions taken must also include proper disposition of the affected product. The corrective actions should include:

• Determining the disposition of non-conforming product,
• Correcting the cause of non-conformity to prevent recurrence,
• Demonstrating that the CCP is once again under control and results are within the critical limits,
• Maintaining records of corrective actions.

Principle 6 — Establish Verification Procedures: Monitoring and auditing methods, procedures and tests, including random sampling and analysis, can be used to determine if the HACCP system is working correctly and effectively. Examples of verification activities include:

• Review of deviations and product dispositions,
• Review of the HACCP system and its records,
• Operations to determine if CCPs are under control, and
• Validation of established critical limits.

Principle 7 — Establish Documentation and Record Keeping: Documentation of HACCP procedures at all steps should be included and assembled in a manual. The types of records that might be retained are as follows:

• HACCP plan,
• Amendment to HACCP plan,
• CCP monitoring records,
• Training records,
• Audit records,
• Meeting records,
• HACCP system procedures.
  

Table 5.3.6 FDA-specified standard methods for analysis of dairy products (Pg 343)