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Validating our foreign material control program

validation foreign material control foreign material physical contamination complaints

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#1 sbarzee


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Posted 29 October 2015 - 04:18 AM

We are SQF level 2 certified, and I need to validate our foreign material control program. This is not the metal detector CCP validation, but validation of our entire foreign control program (glass, wood, plastic, etc.).
I'm basing the validation on a review of our customer complaints for the year. I'm assuming even just one customer complaint that implicates our process deems the program unvalidated, at least for that kind of contaminant. Does anyone have any other validation methods or suggestions? Is my assumption a good assumption, or might it be acceptable to establish a limit or target for the number of physical contamination complaints vs. product produced annually? For example, if complaints are not repeat complaints of the same lot, and only represent 0.005% of total product, then the program is deemed validated. Hmmm...that sounds like a critical limit question. I'm confusing myself, but if anyone has any ideas. I'd appreciate your input.

#2 Tony-C


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Posted 29 October 2015 - 05:09 AM

Hi sbarzee,


A good question, and an area where there is confusion between validation and verification. From the SQF Code/Implementation Guidance:


2.5.2 Validation & Effectiveness (M) The methods, responsibility and criteria for ensuring the effectiveness of pre-requisite programs, and validating critical food safety and quality limits to ensure they achieve their intended purpose shall be documented and implemented. The methods applied shall ensure that:
i. Pre-requisite programs are confirmed to ensure they achieve the required result.
ii. Critical limits are selected to achieve the designated level of control of the identified food safety hazard(s) or threat to the achievement of food quality; and
iii. All critical limits and control measures individually or in combination effectively provide the level of control required. Records of all validation activities shall be maintained.
2.5.2 Implementation Guidance
Confirmation of the effectiveness of pre-requisite programs and validation of critical food safety and quality limits is vital to ensuring that the programs and limits achieve their intended purpose, resulting in the production of safe, quality food.
Validation involves testing over and above daily monitoring to ensure that established food safety and quality limits are effective, i.e. achieve the desired results, so that the supplier can have confidence that the product and process are safe. Validation methods will vary depending on the risk to finished product safety. For hazards assessed as high risk, the critical limits must be re-validated annually.
Critical food safety and quality limits are said to be validated because they have been confirmed by scientific analysis. Pre-requisite programs and other food safety and quality controls, however are confirmed by observation, inspection or audit to ensure that they are achieving the desired result.
This is a mandatory element.
The SQF practitioner is responsible for documenting and implementing the methods, responsibility and criteria for confirming the effectiveness of pre-requisite programs and validating critical food safety and quality limits to ensure they achieve their intended purpose. The supplier must demonstrate how the validation methods ensure that the selected critical limits achieve the level of control required for the targeted food safety hazard or threat to product quality. The supplier must also have documentation showing that the methods and control measures provide the level of control needed.
Some potential methods for confirming the effectiveness of specific pre-requisite programs are listed below. The implementation of these specific methods is not necessarily required, but confirmation of the effectiveness of the program is required. This is not an exhaustive list, but provides some examples:
• Personnel practices: Observe employees during the internal audit or daily operational inspection to ensure they are meeting the requirements of the supplier’s program.
• Personnel processing practices: Observe employees during the internal audit or daily operational inspection to ensure they are meeting the requirements of the program.


So firstly verification can be conducted by audits/observation/inspection/records that all items are in good condition and there are no risks etc. Validation as described above is more or less the same but I would follow your path and look to demonstrate compliance in finished product by complaint history and relevant non-conforming product records (foreign body related). I don't believe you need to set a finite number (these would be set in objectives) but based on complaint history you should have some idea of typical levels of complaints. I would conduct an analysis and report on your findings, following up on justified foreign body complaints/NCs to ensure the root cause was analysed and corrections/corrective actions taken. Trends showing improvement in performance and that there is not a common theme of regular foreign body contamination are what as an auditor I would want to see demonstrated.





Also tagged with one or more of these keywords: validation, foreign material control, foreign material, physical contamination, complaints

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