HACCP Team nagging questions: But how do I know it works?
Quality professionals know there are two types of procedures,Validation and Verification, to help insure products are what they say they are and that they are safe. The U.S. FDA defines them as follows (Link to Source):
Validation: That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.
Verification: Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.
In my experience Validation is done when a product is being developed prior to its release to market. Verification tests the product to insure what is being shipped is what the Validation process has shown it to be, for example that a food product contains the ingredients in the amounts specified and other properties such as taste, color, texture, etc. are also within control limits defining the process, a person would feel comfortable feeding it to their family members. Without proper Validation before products ship the validation is done in the field at the customer’s location. This may be acceptable in certain instances, for example if the customer needs the product before it is fully validated in order to begin developing their product. High tech companies often ship prototypes to developers to develop a new electronic device. In the food industry a supplier developing a new type of flavor agent or an additive may be asked to ship a pilot run with limited validation to a baker in order for the baker to try the product in their products to see if it is suitable for their process or to develop a new product. The product is not intended for sale to the consumer but may be if validation is complete and results acceptable.
Russian Proverb: Доверяй, но проверяй
Pronunciation: doveryai, no proveryai Translation: Trust but Verify
Verification Procedures as defined above do not include the monitoring of Critical Control Points and Critical Control Procedures as defined in the Monitoring Procedures. HACCP Verification Procedures are not quality testing at the end of the process since an effective HACCP plan is intended to be sufficient to eliminate hazards.Validation as applied to the HACCP process can be accomplished during regular reviews of the HACCP process to insure that the HACCP Plan is being followed correctly and to review CCP monitoring and corrective action records. The table below provides an example from the U.S. FDA regarding Verification Procedures. (Link Above) In this table Independent Expert(s) are defined as “other than those writing the plan” and may include “additional technical expertise as well as laboratory and plant test studies.”
|Verification Activities Scheduling||Yearly or upon HACCP system change||HACCP Coordinator||Plant Manager|
|Initial Validation of HACCP Plan||Prior to and during initial implementation plan||Independent Expert(s)||HACCP Team|
|Subsequent Validation of HACCP Plan||When critical limits changed, significant changes in process, equipment changed, after system failure, etc.||Independent Expert(s)||HACCP Team|
|Verification of CCP monitoring as described in the plan (e.g., monitoring of patty cooking temperature)||According to HACCP plan (e.g., once per shift)||According to HACCP Plan (e.g., Line Supervisor)||According to HACCP Plan (e.g., Quality Control)|
|Review of monitoring, correction action records to show compliance with the plan||Monthly||Quality Assurance||HACCP Team|
|Comprehensive HACCP system verification||Yearly||Independent Expert(s)||Plant Manager|
US FDA Verification Procedures Example
As in ISO quality processes, the FDA notes that, “a periodic comprehensive verification of the HACCP system should be conducted by an unbiased, independent authority. Such authorities can be internal or external to the food operation. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as on-site review of all flow diagrams and appropriate records from operation of the plan.” A review of the findings will be used to make changes to improve or eliminate deficiencies in the HACCP Plan and other steps. The FDA site provides a list of Examples of Verification Activities (Appendix G) that one may find helpful (Link to Source).
I don’t know why no one has written HACCP for Dummies, but it doesn’t seem to exist, possibly because of the many stages the food production, processing, and distribution, each requiring a separate discussion. Since HACCP has many elements of Quality Control processes and procedures, Quality Control for Dummies which is in print may be an option and will come in handy for a future piece. A web search will reveal many other resources on the web to help get started. As in the previous steps and as in ISO processes, procedures are to be developed that match current practices and insure the desired results, and because of that the team will need need to customize or modify its processes to match their operation’s capabilities without compromising HACCP ideals.
Verification is the step that the HACCP Team can use to understand if their plan works or not. Regular review of the process is critical to insure that the process evolves to meet changes in an organization’s personnel, process changes especially due to changes in raw material supplies, and changes in the business itself. Without regular verification the HACCP Plan will be another dust collector sitting on someone’s shelf only to be rediscovered after bad things happen. A good night’s sleep depends on diligence when it comes to food safety.
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