15 replies to this topic

[chipollinij]

SQF 4.5.2 requires the validation of Pre-requisite programs and records of all validation activities.

 

4.5.2.1 The methods, responsibility and criteria for validating Pre-requisite Programs and critical food safety limits to ensure they achieve their intended purpose shall be documented and implemented.

4.5.2.2 Records of all validation activities shall be maintained.

Can someone provide examples of these validations.

thank you

[Simon]

Surely someone can provide a simple example or two.

[Tony-C]

Methods for validating the effectiveness of specific prerequisite programs :
Observing employees during internal audit to ensure that they are meeting the requirements of your program
Interviewing employees to ensure that job training has bee effective and that key points are understood.
Using an external contractor to confirm that equipment is properly calibrated.
Trending pest activity information to determine that the program is effective.
Environmental testing to ensure that microbiological loads are acceptable.
Validating the effectiveness of a metal detector by inserting a test piece into a product and confirming that the product is rejected.

Validation methods for CCP’s must demonstrate that the hazard is adequately controlled - sources could be:
Scientific literature
Peer-reviewed published research
In-house or laboratory challenge studies
Reference to legally defined CCP’s such as for the pasteurization

There is an example on this website here

Regards,

Tony

[esquef]

Surely someone can provide a simple example or two.

Here's an example od a pre-requisite program validation:

 Glass Policy Validation.docx   49.07KB   1055 downloads

[Tony-C]

And here

Regards,

Tony

[SZY]

One example for validation schedule:

Labeling

Australian and New Zealand Food Standard Code

· Standard 1.2 Labeling and Other Information Requirements

Edited by SZY, 24 June 2011 - 05:30 AM.

[Tony-C]

Here's an example od a pre-requisite program validation:

 Glass Policy Validation.docx   49.07KB   1055 downloads

For some reason it looks very familiar!

Anyway I've tidied it up for you

 Glass Policy Validation amended.docx   24.78KB   648 downloads

Regards,

Tony

[GMO]

I'm not familiar with SQF but in the HACCP sense; anything where you're 'ensuring the effectiveness' once something is in operation is verification; validation is more about pre adoption trials, literature etc etc. So for the above examples I would say the following:

Observing employees during internal audit to ensure that they are meeting the requirements of your program - Verification
Interviewing employees to ensure that job training has bee effective and that key points are understood. - Verification
Using an external contractor to confirm that equipment is properly calibrated. - Possibly validation, on the fence on that one
Trending pest activity information to determine that the program is effective. - Verification
Environmental testing to ensure that microbiological loads are acceptable. - Verification
Validating the effectiveness of a metal detector by inserting a test piece into a product and confirming that the product is rejected. - Monitoring

So my suggestions for validating the above examples will be the following, and I'm by no means certain these are perfect examples; it's a tricky topic validating PRPs:

Internal audit - Train all auditors to an approved training package supplied by a company who has experience in training auditors and test the auditors at the end of the programme, then implement a shadowed auditing with new auditors until they have completed 2 audits for example. The training package, test results and shadowed audits would then be your validation.

Implement training programmes using trained competent staff to deliver the programmes, the content based upon a suitable text or texts (this could include standards, etc) and test the staff at the training programme. Again the source material reference and the testing would be your validation.

Calibration - as is, perhaps with some evidence from the manuals about why you chose your calibration frequency.

Pests - I would have some kind of risk assessment as the validation; that might sound a bit about face but you need to be able to justify what pest control you have chosen, the frequency of audit and the type and number of bait points etc to ensure the site is safe from pests as that is the validation part. (Ie you're chosing your pest control cover as to what you think your risks are.)

Cleaning - you need to do cleaning trials which are monitored then a high level of inspection and swabbing after them (as a trial exercise which you then write up) to ensure the methods used are effective. This would be your validation in conjunction with chemical specs etc. A lower level of environmental swabbing would then be verification.

Metal detection - the validation for this could be two fold; the specification and initial set up by the contractor (to say it can be effective and I've proven it is), and then some evidence for why you chose the test piece size you did (I often use the FDA hard and sharp contaminants document for this.)

For me, validation is about "why am I going to do this" so it must be an activity which could be achieved prior to that PRP, CCP etc being put into place. It might involve practical trials if there is no literature out there to support it but generally these are things you can do without being in full production, otherwise HACCP wouldn't work from day 1.

[Tony-C]

I'm not familiar with SQF

True you are not familiar with the SQF code and whilst I understand your comments - the examples given were from SQF Implementation Guidance

[GMO]

True you are not familiar with the SQF code and whilst I understand your comments - the examples given were from SQF Implementation Guidance

Fair enough! They just have a very funny interpretation of validation then!

[Tony-C]

Fair enough! They just have a very funny interpretation of validation then!

Yep a different tack on verification and validation but I don't mind that as they do a good job of explaining what they are looking for. And a big plus - the SQF 2000 Code is free.

Edited by Tony-C, 26 June 2011 - 09:13 AM.

[chipollinij]

Thank you everyone for your responses. The certification body auditing my plants interprets validation in a unique way. Regulatory requirements are not enough and I must establish criteria (critical limits0 for each prerequisite program. We use a checklist that covers all elements and subelements of the sqf system including section 6 prerequisite programs, however the CB does not feel this is complete. Verification of statements of your GMP's in the plant is not consider validation. Any comments??
Thanks again

[Sean Archer]

CB auditors are completely right.
You can use checklists for verifying your PRP but not for validation. Validation is related to "Why" whereas verification is concerned in "How". Therefore, validation records shall include methods of validation, acceptance criteria and revalidation period. As an example, cleaning validation can be practiced since there is some information in the internet to begin with.

Normally, a PRP includes "What/Where", "Who", "When", "How" and "reference SOP" coloumns. So you have to validate all the coloumns under a bullet of your PRP.

[esquef]

CB auditors are completely right.
You can use checklists for verifying your PRP but not for validation. Validation is related to "Why" whereas verification is concerned in "How". Therefore, validation records shall include methods of validation, acceptance criteria and revalidation period. As an example, cleaning validation can be practiced since there is some information in the internet to begin with.

Normally, a PRP includes "What/Where", "Who", "When", "How" and "reference SOP" coloumns. So you have to validate all the coloumns under a bullet of your PRP.

Quoting from the SQF 2000 Guidance document (4.5 Verification):

Verification is the proving that you are doing what you say you are doing.
Validation is the proving that what you are doing is working and effective.

Sounds easy but it's tricky (and potentially expensive) when you're trying to validate and verify a pre-requisite program like Allergen Control.

[mgourley]

It seems that SQF has not done any favors by basically mashing together verification and validation.
GMO is absolutely correct from a Codex perspective re validation and verification.

[esquef]

It seems that SQF has not done any favors by basically mashing together verification and validation.
GMO is absolutely correct from a Codex perspective re validation and verification.

That's absolutely true!!!!