24 replies to this topic

[SS2010]

Dear Friends,

I have got lil bit of query on here!

SQF 4.5.1.2 & 4.5.2.1 SAYS " the method ,responsibility and criteria for validationg pre-requisite programs and critical food safety and quality limits to ensure they achieve their intended purpose shall be documented and implemented.

So query is how can I validate the PREREQUISITE PROGRAM

The prerequisite program we have

1)Cleaning and sanitation
2)Pest control
3)Allergen control
4)Calibration
5)Approved supplier program
6)GMP/ghp
7)Training
8)Control of physical contamination

Iam veryfying this program BUT HOW CAN I VALIDATE THEM?????


Please guide me by your ideas on each of the prps ...that would be king of yours!!

[esquef]

What's really important to understand is that the SQF Practitioner is responsible for singing off on all policies and documents in the SQF system. The Practitioner doesn't have to write them, but they do have to sign off on them and they are accountable that the policies/documents, etc. do accomplish what they're saying. Here're are a few ideas for you:

1)Cleaning and sanitation

Validation might include micro and/or ATO testing (swabs), visual confirmation, etc.


2)Pest control

An example of validation if you have a contract pest controller would be to check traps after a visit to see if the findings were accurate (for example if he says no mice were forund in traps or no insect infestation was noed during the inspection you woud check all traps and look for signs of insect infestation to see if that
finding was true; or you could do the old trick and put a fake mouse or your business card in one of the traps and see if he finds and reports it.


3)Allergen control

If your written prerequisite allergen program covers items such as segregation, labeling, prevention of cross comtamination, validated SSOP's that show that your sanitation procedures effectively remove all traces of allergens after processing equipment wash downs....



4)Calibration

Proof that a qualified technician callibrated scales, thermometers, etc. (ex. a certificate and/or bill from an outside calibration company)



5)Approved supplier program

Your audits of your suppliers, supplier questionnaires, risk assessments, etc.



6)GMP/ghp

Your written cGMP program that's been validated by the SQF Practitioner by doing walk throughs, proof of training of all employees, etc.



7)Training

Contents of the the training and signatures of attendees of all necessary employee training



8)Control of physical contamination

Written prereq programs that are signed off by the SQF Practioner as being effective in the prevention of physical contamination (this could be cGMP's, cross comtamination prevention policies/programs, etc.



Hope that helps a little!

esquef

Edited by esquef, 24 February 2011 - 04:49 PM.

[Charles.C]

Dear esquef,

I admire yr ingenuity.

One possible objection to the procedures in yr post is that some people (auditors?) might consider them as part of the customary verification procedure.

Does SQF also require this element in addition to validation?

Rgds / Charles.C

[esquef]

Dear esquef,

I admire yr ingenuity.

One possible objection to the procedures in yr post is that some people (auditors?) might consider them as part of the customary verification procedure.

Does SQF also require this element in addition to validation?

Rgds / Charles.C

Thanks for the kind words Charles!

Generally speaking, in SQF Speak (at least as I understand it), Verification means "are we doing what we're saying?", while Validation means "is what we're doing effective?". Does that clear up any confusion I may have created?

[DAVE84]

Well here i have different thinking in validating pest control plan.

To verify plan: i would observe the pest control guy performing task.

To validate: I will check six month records. If i do not have any rodent inside the facility traps, it validates my pest control plan that yes it is working. But if i find few finding of rodents from inside the facility traps, it means that my pest control plan is not working go. I will go ahead and change location of outside traps and will validate it again.

Dave

[Charles.C]

Dear esquef,

After posting my comments, I recalled a previous recent thread where there was also some debate over the SQF concept of validation / verification, a discussion which, from memory, was ultimately inconclusive.

For convenience, I have posted below some extracts from the SQF guidance document / Codex viewpoint.

SQF2000

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

Validation – Do the prescribed procedures work? Is the process as it has been developed effective?
Does it work?

Verification – Are you following the prescribed procedures as they are written, or simply, are you doing what you say that you are doing?

Examples of validation could be studies to prove effectiveness of critical limits as stated in the implementation guidance for Section 6.9.2. Other examples could be verifying product temperature on a scheduled thermal process, microbiological testing of product to ensure desired reduction of product rinse
system and product quality panel reviews for finished product.

Examples of verification of programs could include review of inspection records to ensure all monitoring tasks are completed at the frequency that is defined, ensuring that internal audits occur at the frequency defined.

Codex

Validation: Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.

Validation is performed at the time a control measure or a food safety control system is designed, or when changes indicate the need for re-validation. Validation of control measures is, whenever possible, performed before their full implementation.

Validation of control measures as described in this document is different from monitoring and verification, which both take place after the validated control measures have been implemented.

Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.

Verification is an ongoing activity used to determine that the control measures have been implemented as intended. Verification occurs during or after operation of a control measure through a variety of activities, including observation of monitoring activities and review of records to confirm that implementation of control measures is according to design.

By comparison my opinion for the general case is –

Verification - similar. Both definitions indicate that the activity is undertaken after implementation of the chosen control measures.

Validation – variable. Codex specifies that related activities typically occur before the routine implementation of the CM (no specific reference to prerequisites as far as I could see). The examples in SQF seem to include activities before and after, eg CCP activities are before, prerequisite programs after (eg 4.5.2.1 Guidance document).

Comments

I suspect that SQF’s original designers got themselves into a semantic tangle over the Va/Ve issue, and particularly for words like effective, working (not only SQF of course!). The former can be found within definitions of both verification (eg see the 12 haccp steps flowchart) and validation. A few consequences -

Validation
The interpretation of the word “work(ing) in the two validation definitions given in the guidance document is unclear IMO, ie logically it implies after routine implementation of the CM but this usage then has a problem regarding CCP validation which is invariably before implementation of any CMs).
To avoid further awkward explanation SQF provided highly explicit detail regarding possible options for validating the PRPs.

Verification
Relatively little detail is given on this in the Guidance document, particularly for PRPs. I suspect this is due to the fact that some of the recommended validation procedures given for the PRPs are typically used for verification purposes in other references.
It is possible that SQF place more importance on (their) validation than (their) verification.

Regardless it is at least clear from the Guidance document what they want regarding validation of PRPs which is one point in SQF's favour.
Perhaps less detail is expected for verification aspects where an overlap with validation may occur.

As a side-note I noticed that the SQF (Guidance) definition of CCP is also not the same as Codex, ie -

Process points that “prevent, eliminate, or reduce food safety hazards” are to be designated as critical control points (CCPs). (4.4.3.1)

This is very flexible indeed.

SQF users are of course welcome to comment (maybe correct ) on the above.

Rgds / Charles.C

[SS2010]

Thanks a lot ,

But as per my understanding ,SQF auditors are considering all these activity as a verification activity!!

Thats y m really wondering how can i validate them?

What's really important to understand is that the SQF Practitioner is responsible for singing off on all policies and documents in the SQF system. The Practitioner doesn't have to write them, but they do have to sign off on them and they are accountable that the policies/documents, etc. do accomplish what they're saying. Here're are a few ideas for you:

1)Cleaning and sanitation

Validation might include micro and/or ATO testing (swabs), visual confirmation, etc.


2)Pest control

An example of validation if you have a contract pest controller would be to check traps after a visit to see if the findings were accurate (for example if he says no mice were forund in traps or no insect infestation was noed during the inspection you woud check all traps and look for signs of insect infestation to see if that
finding was true; or you could do the old trick and put a fake mouse or your business card in one of the traps and see if he finds and reports it.


3)Allergen control

If your written prerequisite allergen program covers items such as segregation, labeling, prevention of cross comtamination, validated SSOP's that show that your sanitation procedures effectively remove all traces of allergens after processing equipment wash downs....



4)Calibration

Proof that a qualified technician callibrated scales, thermometers, etc. (ex. a certificate and/or bill from an outside calibration company)



5)Approved supplier program

Your audits of your suppliers, supplier questionnaires, risk assessments, etc.



6)GMP/ghp

Your written cGMP program that's been validated by the SQF Practitioner by doing walk throughs, proof of training of all employees, etc.



7)Training

Contents of the the training and signatures of attendees of all necessary employee training



8)Control of physical contamination

Written prereq programs that are signed off by the SQF Practioner as being effective in the prevention of physical contamination (this could be cGMP's, cross comtamination prevention policies/programs, etc.



Hope that helps a little!

esquef

[SS2010]

Dear Chrles,

I DO AGREE

I read the SQF guideline,

IN GENERAL Validation is to check the effectiveness before the implementation,

whereas SQF guide says :Check the effectivenes after the implementation( in context of PRPS ) and they are considering it Validation...

trouble creator!!

If i would be the auditor then i will definitely consider those element as a verification and raise Major CAR

M afraid if i will get audtor and she/he will consider these activity as a verification then can get CAR which i dont want..........

so guys please gimme solution....

kind regards
ss

Dear esquef,

After posting my comments, I recalled a previous recent thread where there was also some debate over the SQF concept of validation / verification, a discussion which, from memory, was ultimately inconclusive.

For convenience, I have posted below some extracts from the SQF guidance document / Codex viewpoint.

SQF2000









Codex








By comparison my opinion for the general case is –

Verification - similar. Both definitions indicate that the activity is undertaken after implementation of the chosen control measures.

Validation – variable. Codex specifies that related activities typically occur before the routine implementation of the CM (no specific reference to prerequisites as far as I could see). The examples in SQF seem to include activities before and after, eg CCP activities are before, prerequisite programs after (eg 4.5.2.1 Guidance document).

Comments

I suspect that SQF’s original designers got themselves into a semantic tangle over the Va/Ve issue, and particularly for words like effective, working (not only SQF of course!). The former can be found within definitions of both verification (eg see the 12 haccp steps flowchart) and validation. A few consequences -

Validation
The interpretation of the word “work(ing) in the two validation definitions given in the guidance document is unclear IMO, ie logically it implies after routine implementation of the CM but this usage then has a problem regarding CCP validation which is invariably before implementation of any CMs).
To avoid further awkward explanation SQF provided highly explicit detail regarding possible options for validating the PRPs.

Verification
Relatively little detail is given on this in the Guidance document, particularly for PRPs. I suspect this is due to the fact that some of the recommended validation procedures given for the PRPs are typically used for verification purposes in other references.
It is possible that SQF place more importance on (their) validation than (their) verification.

Regardless it is at least clear from the Guidance document what they want regarding validation of PRPs which is one point in SQF's favour.
Perhaps less detail is expected for verification aspects where an overlap with validation may occur.

As a side-note I noticed that the SQF (Guidance) definition of CCP is also not the same as Codex, ie -

This is very flexible indeed.

SQF users are of course welcome to comment (maybe correct ) on the above.

Rgds / Charles.C

[Charles.C]

Dear SS2010,

Well, one possibility as presented by Codex and illustrated for both validation / verification of the cleaning process (Example3) is via this rather neat (IMO) route –

If review and analysis of the validation results indicate that the SSOPs are capable of consistently delivering results that comply with the established microbiological criteria during 3-4 weeks of the validation period, then the cleaning and disinfection protocols can be considered validated.
This same protocol with a reduced rate of testing can be used as an ongoing verification activity that the SSOPs are being implemented properly.

Full details are given in the Codex attachment below.

Codex also use a similar approach for metal detectors (Example 4)

I have no idea whether the above logic is acceptable to SQF auditors but the general idea seemed very reasonable to me. Plus at least the method is "respectably" validated.

 Codex, guidelines for validation of FS control measures.pdf   170.26KB   938 downloads

Rgds / Charles.C

PS - I don't wish to appear over-critical of SQF since their provision of a free Standard / Guidance material is very generous indeed but I also noticed this chunk regarding validation of metal detectors -

Metal detectors, x-ray, color sorters (if used for defects or foreign material) must be validated to ensure
that they can effectively detect a foreign object within the packaged product that is passed through the
device. Validation is not the passing of wands through the device to ensure that it is working, this is verification. An example of a means for validation of a metal detector would be the placing of a piece of metal within the package of product.

I really don't get the logic.

[Dale P]

I really don't get the logic.

That makes two of us.
The only reasoning for that guidance I can come up with is that the passing of the test wand verifies that it is working (I can see that), and the placing a metal piece in the package (and testing) is a form of simulated production conditions, which (although also verifies) validates that the intended result is achieved.

[Tony-C]

I really don't get the logic.

Mmmmm. That is because to quote Spock ...."That is illogical Captain". IMO Validation is objective evidence that the control measures and limits are effective in controlling the hazard. Verification is demonstrating that they are operationally effective.

I do think the wording in the SQF Code doesn't help and makes the subject a little bit more confusing.

The SQF Guidance does try and clarify their expectations:

Verification is the proving that you are doing what you say that you are doing. Validation is the proving that what you are doing is working and effective. Examples of verification of programs could include review of inspection records to ensure all monitoring tasks are completed at the frequency that is defined, ensuring that internal audits occur at the frequency defined.
Examples of validation could be internal studies to prove effectiveness of critical limits as stated in the implementation guidance for Section 6.9.2. Other examples could be verifying product temperature on a scheduled thermal process, microbiological testing of product to ensure desired reduction of product rinse system and product quality panel reviews for finished product.

There are some good post explaining validation/verification on the forums, try reading this again from Charles.

Regards,

Tony

[Tony-C]

That makes two of us.
The only reasoning for that guidance I can come up with is that the passing of the test wand verifies that it is working (I can see that), and the placing a metal piece in the package (and testing) is a form of simulated production conditions, which (although also verifies) validates that the intended result is achieved.

Yes but for me validation would be that say for example being able to reject a 4mm Stainless Steel bit of metal in your product is an acceptable control measure and limit.

SQF takes this view:

An example of a means for validation of a metal detector would be the placing of a piece of metal within the package of product (Product would be properly labeled to ensure it does not enter market). All types of packaging and sizes of product that are passed through the device must be validated. Any new packaging or size of product must be validated.

Which as you have pointed out would be interpreted as verification by some people. It doesn't really matter whether you call it validation or verification, it is something that needs to be done.

Regards,

Tony

[chipollinij]

Dear esquef,

I admire yr ingenuity.

One possible objection to the procedures in yr post is that some people (auditors?) might consider them as part of the customary verification procedure.

Does SQF also require this element in addition to validation?

Rgds / Charles.C

[chipollinij]

Correct, Auditors consider this verification. SQF requires the validation process to be separate from verification..

[John Antecki]

I see the age old Verification /Validation, definition debate is still going strong!

Enough verification can, provided the results are of a positive nature meaning , no outrageously increased trends are proven through the verification, will validate the effectiveness of PRP's.

I generally do these tasks, which can be a bit different from PRP to PRP, for validation.

• Criteria is taken from .gov site, including verification frequency, research, research, research (This is called initial validation)
• Visual inspection, internal audits
• Verify historical documentation of PRP's, CL's
• Trend analysis - using excel
• Write a Validation report detailing the findings.

Hope i can help..

John>

[Charles.C]

Dear John,

Enough verification can, ......verification, will validate the effectiveness of PRP's.

I believe you are trying to prove that there is no difference between Va and Ve.?
(or perhaps that verification should be nested within validation, ie the reverse of the traditional American philosophy )

Maybe we should ban both words and replace them by "Proof of Effectiveness" (POE) where this requires adequate scientific / chronological evidence for both.

Rgds / Charles.C

[Katja]

SQF is very confusing in its interpretation of verification and validation, the best help has been the SQF guidebook which gives you ways to validate your prerequisite programs. for example
cleaning and inspection: perform environmental testing to ensure that microbial load are acceptable.
Allergen control: validate the effectiveness of cleaning programs using rapid allergen testing methods,
personnel practices: observe employees during internal audit to ensure they are meeting the requirements of your program
pest control: trend pest activity information to determine if program is effective

What i did was a combination of historical data and trend analysis from non-conformities noted duirng audits or monitoring records. Soi i trended pest activity from monitoring records over past years and i added the information from complaints register in regards to pest activity. Pest activity trended was minimal and what we do must be effective because we had no valide complaints from customers.
I observed compliance and asked questions to operators in regards to personal hygiene practices. The answers were correct and with the added information collevcted from non-conformities form past years specifically linked to personal hygiene indicate that the training and practices are effective.

Its difficult and sometimes you have to find round-about ways to prove that what you do is effective.
good luck

[Urban Explorer]

I've attached our prerequisite verification / validation table which gives some examples of how we say what we do, etc.

I hope this may help you a little bit, plus all the extra great advice noted above.

Attached Files

•  Prereq Verification Table.xls   49.5KB   1053 downloads

[Charles.C]

SQF is very confusing in its interpretation of verification and validation, the best help has been the SQF guidebook which gives you ways to validate your prerequisite programs. for example
cleaning and inspection: perform environmental testing to ensure that microbial load are acceptable.
Allergen control: validate the effectiveness of cleaning programs using rapid allergen testing methods,
personnel practices: observe employees during internal audit to ensure they are meeting the requirements of your program
pest control: trend pest activity information to determine if program is effective

What i did was a combination of historical data and trend analysis from non-conformities noted duirng audits or monitoring records. Soi i trended pest activity from monitoring records over past years and i added the information from complaints register in regards to pest activity. Pest activity trended was minimal and what we do must be effective because we had no valide complaints from customers.
I observed compliance and asked questions to operators in regards to personal hygiene practices. The answers were correct and with the added information collevcted from non-conformities form past years specifically linked to personal hygiene indicate that the training and practices are effective.

Its difficult and sometimes you have to find round-about ways to prove that what you do is effective.
good luck

Dear Katja,

The problem is simple - a variety of substantially different "official" interpretations of Va/Ve exist. For example, IMO, most of your SQF "validations" as stated above would be regarded by Codex as "Verifications". ISO 22000 does not even require you to "validate" (their) prerequisites.

All variations may well be correct within their own implementations. The sadder aspect is that it means that users may have to be prepared to create a new (opposite?) set of responses for different standards.

Rgds / Charles.C

PS Traditionally, the USA (HACCP) approach to the VA/Ve aspects has i think been to include validation as a subset of verification. This does appear to now be changing somewhat. Not sure that it matters really.

[John Antecki]

Touche' Charles,
I do not mean that they are the same.
What i was getting at is that the verification is one of many methods to provide validation.. It has worked perfectly on my last two implementations. Unfortunately a lot of small companies don't have accredited lab on site. Making the traditional methods financially unreachable.
Validation
Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre
determined specifications and quality attributes." (FDA 1987).

Sounds like documented verification in a controlled environment.

I Do like you POE idea though!!

John.

Dear John,



I believe you are trying to prove that there is no difference between Va and Ve.?
(or perhaps that verification should be nested within validation, ie the reverse of the traditional American philosophy )

Maybe we should ban both words and replace them by "Proof of Effectiveness" (POE) where this requires adequate scientific / chronological evidence for both.

Rgds / Charles.C

[bacon]

As Charles and John Antecki have mentioned (as well as many other people have commented on) the different uses of Verification vs. Validation per Codex, HACCP/FDA and SQF....

Please note on page 23 of SQF Code (issue 7)

"1.9 SQF Guidance Documents":

"The guidance documents are available to assist the supplier, but are not auditable documents. Where there is a
divergence between the guidance document and the SQF Code, the SQF Code prevails."


It appears that SQF noticed their inconsistency with their references on page 36:

b) References
The SQF Code makes reference to the current edition of the CODEX Alimentarius Commission Guidelines for the
Application of the Hazard Analysis and Critical Control Point (HACCP) System and the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF) Hazard Analysis and Critical Control Point Principles and Application
Guidelines, adopted August 14, 1997.


So, if one references ones definition source, one has a solid defense.

Cheers

Edited by baron, 17 September 2012 - 05:38 PM.

[Tony-C]

It appears that SQF noticed their inconsistency with their references on page 36:

b) References
The SQF Code makes reference to the current edition of the CODEX Alimentarius Commission Guidelines for the
Application of the Hazard Analysis and Critical Control Point (HACCP) System and the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF) Hazard Analysis and Critical Control Point Principles and Application
Guidelines, adopted August 14, 1997.

So, if one references ones definition source, one has a solid defense.

Cheers

 

Indeed and in 2.5.1 Implementation Guidance:
'Definitions of validation and verification differ slightly from standard to standard.
The GFSI Guidance Document version 6.2 defines validation as “an activity to obtain evidence that a requirement is controlled effectively” and verification as “a confirmation through the review of effective evidence that requirements have been fulfilled.” SQF uses the Codex definition.'

[Charles.C]

I guess it's basically a simple question -

 

Dear "SQF",

 

As per the (update) procedure in yr Standard’s own glossary, have you implemented the Codex "GUIDELINES FOR THE VALIDATION OF FOOD SAFETY CONTROL MEASURES (CAC/GL 69 – 2008)"  yet ?

 

Rgds / Charles.C

[Tomato Country Girl]

Well here i have different thinking in validating pest control plan.

To verify plan: i would observe the pest control guy performing task.

To validate: I will check six month records. If i do not have any rodent inside the facility traps, it validates my pest control plan that yes it is working. But if i find few finding of rodents from inside the facility traps, it means that my pest control plan is not working go. I will go ahead and change location of outside traps and will validate it again.

Dave

Good analogy that is my understanding as well and I attended the Verification vs Validation class at last year's SQF Conference.

[Charles.C]

Good analogy that is my understanding as well and I attended the Verification vs Validation class at last year's SQF Conference.

Dear Tomato Girl,

 

Thks for the interesting input.

 

Some users of the SQF standard here have recently experienced inconsistencies in the way SQF auditors are handling the assessment of Va and Ve, particularly Va.

 

It is possible IMO that this is due to the SQF Standard’s interpretation of Validation being rather different to most other current Food reference texts. The result is "auditor confusion".

 

Yr post may partially  validate this hypothesis.

 

Rgds / Charles.C