21 replies to this topic

[Kellio]

I would like some Ideas in how to create and implement a verification and validation program. Also, to create a verification and validation schedule. Any pointers it will be greatly appretiated.


Thank you in advance. This site has help a non Quality Assurance person like me to be "Food Safety Man" I appretiate the knowledge you share.

[Charles.C]

I would like some Ideas in how to create and implement a verification and validation program. Also, to create a verification and validation schedule. Any pointers it will be greatly appretiated.


Thank you in advance. This site has help a non Quality Assurance person like me to be "Food Safety Man" I appretiate the knowledge you share.

Dear Kellio,

The scope of yr question is quite large.

First suggestion is to consult the downloadable SQF guidance manual, if unavailable for ver 7 (not sure) try for previous version (2000 prob.) which is mostly same IMEX.

SQF is notorious for oddness over this topic so general responses to yr query may be incorrect. SQF's guidance info. is usually accurate albeit sometimes a little confusing.

i can recall seeing some example (probably SQF) schedules here in the past, should repeat again that SQF can be atypical.

Rgds / Charles.C

[CiliaB]

hi K
firstly make a list of all equipment you need to calibrate

make the list with all serial numbers
decide on the frequency of calibration - obviously you will need to ask the manufacture and please ask for the certificate

you have the list , serial numbers and frequency, now you need to have a record sheet to fill in ...
this will be date / equipment / reading / standard/ sign

Edited by Charles.C, 23 February 2013 - 10:26 PM.
various posts combined

[CiliaB]

Sorry I have no idea to copy mine in for you I will see if I can do this.

Validation will be more frequent than calibration
ie scales will be done annually or twice and validation will be done daily before the shift starts.

[Kellio]

Dear Kellio,

The scope of yr question is quite large.

First suggestion is to consult the downloadable SQF guidance manual, if unavailable for ver 7 (not sure) try for previous version (2000 prob.) which is mostly same IMEX.

SQF is notorious for oddness over this topic so general responses to yr query may be incorrect. SQF's guidance info. is usually accurate albeit sometimes a little confusing.

i can recall seeing some example (probably SQF) schedules here in the past, should repeat again that SQF can be atypical.

Rgds / Charles.C

Thank you Charles for your response.

Understood!!!


SQF was hard on us with this verification and validation schedules this year and just want to improve our program. I just want to see what everybody's is doing in this area or industry practices. I just saw a post in this subject which is a good pointer.

To be honest with you, SQF is kind of "wierd" about this kind of programs so I learn to use ISO 22000 templates to pass SQF every year.

Thank you

[Kellio]

hi K
firstly make a list of all equipment you need to calibrate

make the list with all serial numbers
decide on the frequency of calibration - obviously you will need to ask the manufacture and please ask for the certificate

you have the list , serial numbers and frequency, now you need to have a record sheet to fill in ...
this will be date / equipment / reading / standard/ sign

Thank you, I think I will use your comment to start reviewing other PRP's and see how this is going to evolve. Ours was not robust enough. This is a good starting point.

Edited by Kellio, 15 March 2013 - 05:37 PM.

[williamw]

We created a combined document that covered our forms and records list, verification schedule and validation schedule along with frequencies and responsibilities.

Forms/Record(Responsibility) Verification(Responsibility) Validation(Responsibility)


So for example in our Scale/Balance calibration section the first column contains something like: Balance/Scale Calibration Checks- Form xxxx (Daily by assigned QC Tech)

Annual 3rd party calibration records (SQF Practitioner)

The verification column contains something like: Reveiw of Balance/Scale Calibration Check Form (Daily by assigned QC Supervisor)

And the validation column contains: Annual outside 3rd party calibration (SQF Practitioner)

Of course details such as how to perform calibration checks, weights to be used, certification of test weights, certification of outside calibration contractor, etc. are contained in other documents, but this one document covers a lot of the schedules and list required by the standard.

Keep in mind that this covers a lot more than calibration, so we have sections for each prerequisite program and CCP and include all of the records, validation, verification and basic responsibilities associated with each program area.

[Charles.C]

Dear kellio,

You might find this extracts from the 1997 NACMCF document of interest -
( http://www.ifsqn.com...dpost__p__59279 )

Examples of Verification Activities

Verification procedures may include:
Establishment of appropriate verification schedules.
Review of the HACCP plan for completeness.
Confirmation of the accuracy of the flow diagram.
Review of the HACCP system to determine if the facility is operating according to the HACCP plan.
Review of CCP monitoring records.
Review of records for deviations and corrective actions.
Validation of critical limits to confirm that they are adequate to control significant hazards.
Validation of HACCP plan, including on-site review.
Review of modifications of the HACCP plan.
Sampling and testing to verify CCPs.

Verification should be conducted:
Routinely, or on an unannounced basis, to assure CCPs are under control.
When there are emerging concerns about the safety of the product.
When foods have been implicated as a vehicle of foodborne disease.
To confirm that changes have been implemented correctly after a HACCP plan has been modified.
To assess whether a HACCP plan should be modified due to a change in the process, equipment, ingredients, etc.

Verification reports may include information on the presence and adequacy of -
The HACCP plan and the person(s) responsible for administering and updating the HACCP plan.
The records associated with CCP monitoring.
Direct recording of monitoring data of the CCP while in operation.
Certification that monitoring equipment is properly calibrated and in working order.
Corrective actions for deviations.
Sampling and testing methods used to verify that CCPs are under control.
Modifications to the HACCP plan.
Training and knowledge of individuals responsible for monitoring CCPs.
Validation activities.

(I'm certain nobody does all the above!)

And a schedule -  Verification (inc.Validation) Schedule.png   21.61KB   203 downloads

Rgds / Charles.C







-

[jenky]

Like williamw, we also combined our verification and validation schedule into one document. For each program, we list the verification/validation activity with the frequency and person responsible. We recently had our first SQF audit, and our auditor was satisfied with this approach. Additionally, for validation, we followed the Codex Guidelines:  Codex - Validation of FS control measures.pdf   170.26KB   402 downloads.

Good luck!

[Charles.C]

Like williamw, we also combined our verification and validation schedule into one document. For each program, we list the verification/validation activity with the frequency and person responsible. We recently had our first SQF audit, and our auditor was satisfied with this approach. Additionally, for validation, we followed the Codex Guidelines:  Codex - Validation of FS control measures.pdf   170.26KB   402 downloads.

Good luck!

Dear Jennifer,

In view of the well-documented confusions between Codex Va/Ve and SQF, i congratulate you on not having encountered any problems.
Maybe SQF auditors are beginning to ignore some of the idiosyncrasies of their own standard.
(eg, for comparison, this thread - http://www.ifsqn.com...dpost__p__56516 )

Rgds / Charles.C

[Kellio]

We created a combined document that covered our forms and records list, verification schedule and validation schedule along with frequencies and responsibilities.

Forms/Record(Responsibility) Verification(Responsibility) Validation(Responsibility)


So for example in our Scale/Balance calibration section the first column contains something like: Balance/Scale Calibration Checks- Form xxxx (Daily by assigned QC Tech)

Annual 3rd party calibration records (SQF Practitioner)

The verification column contains something like: Reveiw of Balance/Scale Calibration Check Form (Daily by assigned QC Supervisor)

And the validation column contains: Annual outside 3rd party calibration (SQF Practitioner)

Of course details such as how to perform calibration checks, weights to be used, certification of test weights, certification of outside calibration contractor, etc. are contained in other documents, but this one document covers a lot of the schedules and list required by the standard.

Keep in mind that this covers a lot more than calibration, so we have sections for each prerequisite program and CCP and include all of the records, validation, verification and basic responsibilities associated with each program area.

Thank you williamm for your info. This is really good information and I will use it to improve my porgram.

[Kellio]

We created a combined document that covered our forms and records list, verification schedule and validation schedule along with frequencies and responsibilities.

Forms/Record(Responsibility) Verification(Responsibility) Validation(Responsibility)


So for example in our Scale/Balance calibration section the first column contains something like: Balance/Scale Calibration Checks- Form xxxx (Daily by assigned QC Tech)

Annual 3rd party calibration records (SQF Practitioner)

The verification column contains something like: Reveiw of Balance/Scale Calibration Check Form (Daily by assigned QC Supervisor)

And the validation column contains: Annual outside 3rd party calibration (SQF Practitioner)

Of course details such as how to perform calibration checks, weights to be used, certification of test weights, certification of outside calibration contractor, etc. are contained in other documents, but this one document covers a lot of the schedules and list required by the standard.

Keep in mind that this covers a lot more than calibration, so we have sections for each prerequisite program and CCP and include all of the records, validation, verification and basic responsibilities associated with each program area.

Thank you williamm for your info. This is really good information and I will use it to improve my program.

[Kellio]

Like williamw, we also combined our verification and validation schedule into one document. For each program, we list the verification/validation activity with the frequency and person responsible. We recently had our first SQF audit, and our auditor was satisfied with this approach. Additionally, for validation, we followed the Codex Guidelines:  Codex - Validation of FS control measures.pdf   170.26KB   402 downloads.

Good luck!

Thank you for sharing this information. I browsed it and it is good stuff. Your comments are greatly appreciated.



Thanks

[Kellio]

Dear kellio,

You might find this extracts from the 1997 NACMCF document of interest -
( http://www.ifsqn.com...dpost__p__59279 )

Examples of Verification Activities

Verification procedures may include:
Establishment of appropriate verification schedules.
Review of the HACCP plan for completeness.
Confirmation of the accuracy of the flow diagram.
Review of the HACCP system to determine if the facility is operating according to the HACCP plan.
Review of CCP monitoring records.
Review of records for deviations and corrective actions.
Validation of critical limits to confirm that they are adequate to control significant hazards.
Validation of HACCP plan, including on-site review.
Review of modifications of the HACCP plan.
Sampling and testing to verify CCPs.

Verification should be conducted:
Routinely, or on an unannounced basis, to assure CCPs are under control.
When there are emerging concerns about the safety of the product.
When foods have been implicated as a vehicle of foodborne disease.
To confirm that changes have been implemented correctly after a HACCP plan has been modified.
To assess whether a HACCP plan should be modified due to a change in the process, equipment, ingredients, etc.

Verification reports may include information on the presence and adequacy of -
The HACCP plan and the person(s) responsible for administering and updating the HACCP plan.
The records associated with CCP monitoring.
Direct recording of monitoring data of the CCP while in operation.
Certification that monitoring equipment is properly calibrated and in working order.
Corrective actions for deviations.
Sampling and testing methods used to verify that CCPs are under control.
Modifications to the HACCP plan.
Training and knowledge of individuals responsible for monitoring CCPs.
Validation activities.

(I'm certain nobody does all the above!)

And a schedule -  Verification (inc.Validation) Schedule.png   21.61KB   203 downloads

Rgds / Charles.C







-

Charles,

Thank you for sharing this information and for your time. This is great information. I will put it to use right away. I am beginning to have a better and a clear idea how this works. I will adapt to our operation.

Thanks.

[Setanta]

I am afraid I need to request assistance here are well. In our audit, we got dinged on Validation. We produce frozen foods under SQF Category 20 Recipe Foods Manufacture.

Here is what the auditor wrote."The following non-conformances were identified: 1. Premises and Equipment Maintenance is not included in the food safety fundamentals or pre-requisite programs and there was no documented validation on file for the program. 2. The verification and validation activities described in the verification and validation schedule and the Training SOP's 2.9.1 and 2.9.2 do not match. 3. A documented validation demonstrating that the program is effective has not been completed for the following programs (Training, Calibration, Personnel Practices and Waste Management). 4. Calibration and Waste Management are not included on the verification/validation schedule."

So I have clarified Premises and Equipment Maintenance in our Food Safety Fundamentals. For verification, I have our Plant Manager reviewing our Work Orders monthly, both Corrective and Preventative. And for Validation I have added a Work Order Status showing the number of corrective and preventative WOs generated and the percentages finished in a time frame from Nov 2012 to Apr 2013, completed by the Maintenance Mgr.

I have changed the errors in 2.9.1 and 2.9.2 to match each other and to match the V&V schedule. We have training for new hires during the first week of their employ and we have employee training, with testing, annually. Our weights are verified from the supplier and are calibrated annually. Our scales are calibrated annually. Our thermometers are calibrated weekly and the NIST thermometer is calibrated annually.

I have added this to the Validation schedule for Waste Management.

Verification
Trash removed/Line leads or back ups/Twice Daily or when needed There is a form this is documented on.

Validation
Review premises for proper disposal and cleanliness and use internal audits to keep areas clean and to standard/QA Manager and Plant Manager/Monthly GMP walkthrough

Calibration and Waste Mgmt are on the V&V schedule.


And I am still getting this rejected for "The items you have described for validation would only constitute verification. Validation demonstrates that the program(s) are effectvie at achieving the intended purpose over time. For example, periodic swabbing results that show there is no micorbial growth after sanitation demonstrates that the sanitation program is effective."


What more can I add to our programs? Any advice gratefully accepted!
Thank you!
Setanta

Edited by Setanta, 23 April 2013 - 02:24 PM.

[jenky]

Setana -

Here's how we approached verification / validation for our Waste Management pre-requisite program:


Verification - Visual inspection during pre-op and operational checks, monthly facility inspection, and internal audit (twice per year)

Validation - Evidence that our waste management practices meet federal regulations and industry standards (have CFR 110 GMPs on file). Evidence that no customer complaints or non-conformances are related to failures in waste management practices in past 12 months. Evidence that waste management inspections are performed timely for past six months and deficiencies are effectively corrected.
We used a similar approach with all our of pre-requisite programs. We have a validation report for each pre-requisite program with all of the supporting evidence attached. Our auditor was satisfied with this for all of our pre-requisite programs.


Hope this helps. Good luck.

Jennifer

[Setanta]

I have some changes already submitted to the auditor, if those aren't satifactory, I will certainly add your suggestions!

Thank you!

[Charles.C]

Dear Setanta,

Must initially state that I am not SQF user. In the following comments I have assumed that for Ve-Va, ver.7 is conceptually unchanged as compared Guidance info. for Ver.6, 2008. If otherwise, you may have to disregard / amend some or all of the following opinions.

I’m not sure if this was a first time audit (and no pre-audit). It would be rather surprising if the conceptual aspects of NCs now mentioned. had been previously audit passed with no problems.

Whatever, it looks like you have unluckily fallen foul of the (known) SQF Va/Ve syndrome (ca. bug).

I have extracted the (I think) relevant pages from ver6 Guidance –

 SQF Guidance ver6, 2008, Ve-Va.pdf   87.72KB   160 downloads

IMO and as discussed elsewhere here at some length, the offered “definitions” of (particularly) Va are a semantic mess and essentially mismatched to their stated references.
But regardless, I presume you are simply obliged to follow the practical requirements as stated in the Guidance to be compliant.

I suspect that the auditor’s validation NC revolves around the word “effective”. The data / evidence you have provided (ie as stated in yr post) have been considered insufficient, quite possibly in the context of external supporting refs (yr text does look potentially inadequate [by SQF standards anyway] if not further expanded). For example, can compare the evidential comments in the following post (JenniferB).

I imagine other SQF users have surely encountered similar problems ???

Rgds / Charles.C

[Setanta]

We have been SQF Level II certified for 3 years. This very same V&V schedule did not have this issue last September with the same auditor.

The minor changes I sent in were what the auditor was looking for. I also added the documentation of the Waste Management system by sending in billing statements.

Thank you for the thoughtful replies!
S.

[Charles.C]

We have been SQF Level II certified for 3 years. This very same V&V schedule did not have this issue last September with the same auditor.

The minor changes I sent in were what the auditor was looking for. I also added the documentation of the Waste Management system by sending in billing statements.

Thank you for the thoughtful replies!
S.

Dear Setanta,

Now I'm curious . So what were the minor changes ?

This very same V&V schedule did not have this issue last September with the same auditor.

Something odd going on for sure ??? No caviar for lunch this time ?

Rgds / Charles.C

[Setanta]

Charles:

Re: same V&V, that was my thought! I know auditors are not infalible, but really !

For the Waste Management Verification we listed our trash pick up done at midshift, end of shift or as needed. This is documented on the Mid-Shift Sanitation Form. We also listed the scheduling of the trash compactor pick ups as verification.

For Validation, of the same category we lsited the GMP walk-through done by me and added Validation of the trash pick up by the Plant Manager by a review of the monthly billing to the manifests.

Lastly, some of the general language was cleaned up. But since she couldn't tell us what was wrong with that section, it made for a 'fun' psychic event. "is this the problem?" "Is THIS the problem?"

[Charles.C]

Dear Setanta,

Thks for comments.

Taking Waste Management as an example, I deduce that yr response to the validation requirement is based on 3 features mentioned in the previously posted SQF6 / Va-Ve pdf, namely –

(a) Examples of validation could be internal studies to prove effectiveness ……

(b) 12. Waste management and disposal: Monitor these areas as part of self inspection.
© Validation – Do the prescribed procedures work? Is the process as it has been developed effective? Does it work?

In other words, your waste management program (WMP) / SOP is being validated via a documented, “internal study” demonstrating that (i) evidence of a monitoring scheme which includes the WMP exists, and that (ii) the monitoring scheme shows the WMP is capable of generating satisfactory “results”, ie is effective. (effective IMO could mean many things depending on the actual program, eg BOD control)

The contents of your "first" (unsatisfied) / "second" (accepted) validation schemes as already posted appear to be –

(1) Review premises for proper disposal and cleanliness and use internal audits to keep areas clean and to standard / QA Manager and Plant Manager/Monthly GMP walkthrough

(2) we listed the GMP walk-through done by me and added Validation of the trash pick up by the Plant Manager by a review of the monthly billing to the manifests.

Comments

The scope of the Validation is inevitably determined by the specific SOP text. And perhaps the auditor’s interpretation of “effective”.

The use of the word “review” in yr earlier post could trigger an auditor’s criticism due to the activity being classified as a “Verification”, (eg see pg 32 of pdf). This probably does follow Codex logic. (In contrast, the appearance of the words “over time” in yr quoted auditor’s definition of Va is classic SQF, Codex non-compatibility !). However the word "review" apparently failed to trigger in the accepted scheme. So

I deduce yr SOP for “waste management control” includes a formal “trash pick-up step” but this was not covered in the initial validation. I guess related evidence would be a reasonable auditorial expectation.

I would hv thought it might have been necessary to (further) demonstrate, eg by a completed monitoring form (or forms if “over time”), that the relevant area was actually clear of waste , ie the control was (hygienically) effective but this maybe depends on the nature of the “waste” referred, and the specific SOP text. This aspect seems covered in Jennifer’s approach. So maybe you dodged one there. (maybe suggests auditors are uncertain between each other as to the degree of detail required).

Of course, none of the above explains why there were no negative comments in previous audits. Maybe the auditor has recently had an epiphany or you added a few more over-creative sentences.
But I prefer the “disappointment” theory (hence reluctance to elaborate).

The PRP aspect does (now) seem better handled by ISO22000, ie only Codex-Ve required. Unfortunately some other ISO items are much less benevolent.

A requested return to the previous version at the next audit may stretch your tolerance limits.

Rgds / Charles.C