26 replies to this topic

[Brendan Triplett]

Hey all,

 

The more I read the forums and the guidance the more I get lost.  I feel like I am going down a rabbit hole on this and most of the documents look like they are creating redundancies.  Please, someone, pull me out of this rut.

 

Validation v. Verification v. Internal Audit

 

Where I am standing now I see:

 

Validation as making sure I have documentation (scientific) that my CCPs are set against a standard and are being met.

 

Verification as my daily records are being filled out and I am doing scheduled reviews of my system elements.

 

Internal Audits as intermittent interval challenges to the program's elements.

 

I attached my verification schedule, which may be completely off-base the more I read these things.  Anyone that can give me a hand would be appreciated.  Getting fuzzy-eyed staring at the guidance.  

 

Cheers!

Attached Files

•  Verification Schedule.xlsx   30.31KB   227 downloads

Edited by Brendan Triplett, 01 May 2023 - 11:18 AM.

[Scampi]

Depending on the risk level of your process/finished goods--your schedule looks appropriate to me

 

Validation (scientific study of proposed CCP mitigation measures)

 

Verification (a step verifying a process step is functioning as intended at the prescribed frequencies)

 

Internal Audit (i prefer the term reassessment) is as you said---a process of investigation designed to ensure you meet regulatory and GFSI requirements)

[kingstudruler1]

I probably have an opinion that differs from some on this.   

 

I don't believe that the term "validation" is only meant for CCPS.    I believe that most programs should be validated as well.    I would think that we should want to validate different programs to ensure that they are affective at achieving the intended result.   The standard states "Good Manufacturing Practices are confirmed to ensure they achieve the required results", which is just another way to state "validation".   An extreme example of this might be if you are catching 77 mice every month in your facility.   That might mean to me that your program is not effective.   Or, if you receive numerous complaints regarding foreign material, maybe your program is not achieving the intended results and may need to be evaluated.    

 

For verification.   Perhaps it is somewhere else in your food safety program, but I would want to see more detail.    examples - CCP monitoring records are verified (reviewed) within 7 days by X employee.    Verification of sanitation (visual, atp, etc) are reviewed within X days by X employee.  Inspections of incoming materials are verified (reviewed) by X employee and X frequency.  etc.   

 

I believe that there are cases where your internal audit could be used as evidence of verification or validation.   For instance, if you never witness a hand washing "violation" on a monthly inspection, that could be evidence that employees are trained in hand washing and follow handwashing procedures.  (training is effective).   If a certain area of the faciilty is always unclean, your Master cleaning schedule / cleaning program may be ineffective at achieving the required result.  

[jfrey123]

I'm with kingstudruler1 on this.  OP is mostly right in his clinical description of validation, verification and internal audits, but there are circumstances where you will end up self-validating some of your program.  Take SQF's validation definition:

 

SQF Ed 9, Appendix 2: Glossary: 

Validation: That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP food safety (or quality) plan, when properly implemented, will effectively control the hazards (Codex).

 

 

SQF requires us to validate our own programs, in one manner or another:

 

2.5.1 Validation and Effectiveness (Mandatory)

2.5.1.1 The methods, responsibility, and criteria for ensuring the effectiveness of all applicable elements of the SQF Program shall be documented and implemented. The methods applied shall validate that:

i. Good Manufacturing Practices are confirmed to ensure they achieve the required results;

ii. Critical food safety limits are reviewed annually and re-validated or justified by regulatory standards when changes occur; and

iii. Changes to the processes or procedures are assessed to ensure the controls are still effective.

 

Records of all validation activities shall be maintained.

 

So for your facility's food safety/HACCP program, you're going to want some scientific based validation that the measures you've laid out are going to be effective at controlling the hazards you've identified.  But you're also going to want to review your verification activities (daily checks/paperwork), typically during your internal audits, which will combine to validate that the program is working as intended.

 

For something like your pest control program, there really isn't a validation document you can refer to to justify your program.  You'll need to validate how effective your pest program is by checking the verification records.  You'll trend the data from collection activities, you'll double check your incident logs to verify rodents aren't running amok in your plant, check the internal audit records, and if everything demonstrates you have pests controlled in a satisfactory manner, then you can consider your pest control program validated.

 

The trick lies in documenting your evaluations.  When you take the time review a program from top to bottom, write up what you've checked and what you've discovered.  Get yourself as SQF Practitioner (or whomever carries that role) to sign off on it, include the relevant management team, and when your SQF auditor asks you to show the validation of your xyz program, you can hand them that review to say your company believes the program is under control and working as intended.

[Tony-C]

Hi Brendan,

 

I think your schedule is along the right lines, you should also be carrying out inspections which can assist in verification of GMPs.

 

I find some of the previous SQF Guidance less confusing, from Guidance for Developing, Documenting, Implementing, Maintaining and Auditing an SQF Food Safety System for Manufacturing SQF Code, Edition 8.1–SQF System Elements for Manufacturing:

 

Critical food safety limits are said to be validated because they have been confirmed by scientific analysis. Pre- requisite programs and other food safety controls, however are confirmed by observation, inspection or audit to ensure that they are achieving the desired result.

 

Validation methods for CCP’s or CQP’s must demonstrate that the hazard is adequately controlled. Possible validation for intervention steps used in the processing of product such as a “kill” step, may be one of the following:

• Scientific literature;

• Peer-reviewed published research;

• In-house or laboratory challenge studies;

• Reference to legally defined CCP’s, such as for the pasteurization of milk.

If technology is being used in a manner that is different from that described within literature or research then the supplier must demonstrate how the revised manner of use conforms to the original claim of intervention.

 

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.

• Training of personnel: Interview employees to ensure that job training has been effective and that key points are understood.

• Calibration of equipment: Engage an outside contractor to confirm that equipment is properly calibrated.

• Management of pests and vermin: Trend pest activity information to determine that the program is

effective.

• Premises and equipment maintenance: Trend equipment breakdowns for signs of repeat problems.

• Cleaning and inspection: Perform environmental testing to ensure that microbiological loads are acceptable.

• Water microbiology: Perform water testing to ensure that it meets potability standards.

 

Internal audits are an in-house check to identify gaps or deficiencies in the SQF System and provide a sound basis for deciding on measures for improvement. Internal auditing is a verification method and when used properly, can reduce the uncertainty and risk of external audits.

This element requires the supplier to audit the activities in their System on a regular basis to ensure that everything is running smoothly. Internal audits help the supplier to identify faults in their System so that it can be improved.

 

Kind regards,

 

Tony

[Brendan Triplett]

Thanks everyone for the input on this.  So, my daily checks and walkthrough sheets would be internal audits, or would they be verification activities?  Would the audits have their own form?  Also, my verification schedule is set up to review each of the system elements.  Basically, we are going to review each system element and ensure that we are in compliance either through checking the daily sheets, third part records, or the policy itself for accuracy to the code.  Thoughts?

 

Cheers!

[Brendan Triplett]

Hey all,

 

Looking at the guidance again I can see that SQFI has the checklist that I can use as the internal audit schedule.  It looks an awful lot like the verification schedule that I created for the verification step, just more detailed.

 

I understand the validation is going to be an outside document proving a study for my CCP limits.  I am just confused how the internal audit schedule differs from the verification schedule when they are both checking system elements.  Thoughts?

 

Cheers.

[jfrey123]

Thanks everyone for the input on this.  So, my daily checks and walkthrough sheets would be internal audits, or would they be verification activities?  Would the audits have their own form?  Also, my verification schedule is set up to review each of the system elements.  Basically, we are going to review each system element and ensure that we are in compliance either through checking the daily sheets, third part records, or the policy itself for accuracy to the code.  Thoughts?

 

Cheers!

 

Based on my understanding of your explanation here, I think your daily checks and walkthroughs would count as verification activities.  You're doing a regular check that the procedures are being followed.  Later checking those records, along with other program elements, would count as an audit of that program.  Personal example:  I've had daily/weekly checks that pest control traps are where they're supposed to be, that door closers function and door seals are intact, and that the PCO came when scheduled, as part of my pest control verification.  Once per quarter, I would review the information from checks, trend the information from captured pests, review incident logs for pest problems, and check my pest control program against the published SQF standard to make sure that the pest control was under control and in compliance with the SQF standard.  This quarterly review is an audit, and if the program is working well over the course of a year to control pests, I would consider that the program has been validated.

 

 

 

To your other post about verification schedule vs internal audit schedule:

• Verification Schedule:  I've built a spreadsheet that outlines all of my programs and lists what verifications/checks we do and how frequently we do them.  ATP tests done daily or after each sanitation run + a startup inspection daily as a verification of sanitation, pest traps checked weekly, storage area inspections done weekly, temperature probes for x area checked every two hours, etc.
• Internal Audit Schedule:  Separate spreadsheet describing all internal audits you perform and their frequency.  GMP audit done monthly to include checking training records are complete, check results from weekly inspections, check program meets standards.  Pest control audit performed quarterly to check PCO performance, trend captures data, review weekly checks, check program meets standards.  So on, so forth.

[Scampi]

Daily checks and walk throughs are MONITORING activities (unless you mean shadowing the monitoring employee) You CANNOT check your own work

 

 

The evaluation of the person completing the monitoring would be a VERIFICATION  as would review documents for completeness and accuracy  (your onsite could/should be part of the internal audit/reassessment)

 

Internal audit is making sure your program meets GFSI element or code requirements

 

Validation---scientific study to support a hypothesis (in food manufacturing---a PC or CCP generally) that is then proved during VERIFICATION

 

 

"Validation: Obtaining evidence that the elements of the HACCP plan are effective. Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine compliance with the HACCP plan."

https://www.foodprot...14-Brackett.pdf

 

Verification means conducting a review to confirm a process was performed correctly. Verification answers the question "How do you know it actually happened?"

Example: A manager in a cookie factory reviews production records to confirm that the cookies were baked to the temperature described in the recipe.

Validation refers to the requirement that a food processor use scientifically proven methods to control a hazard. Validation answers the question "How do you know it works?"

Example: A food safety manager collects scientific research to demonstrate that the cooking temperature used in the recipe is effective in eliminating harmful bacteria in the raw product.

https://www.fdareade...n-vs-validation

Edited by Scampi, 03 May 2023 - 05:32 PM.

[Charles.C]

Hey all,

 

Looking at the guidance again I can see that SQFI has the checklist that I can use as the internal audit schedule.  It looks an awful lot like the verification schedule that I created for the verification step, just more detailed.

 

I understand the validation is going to be an outside document proving a study for my CCP limits.  I am just confused how the internal audit schedule differs from the verification schedule when they are both checking system elements.  Thoughts?

 

Cheers.

Hi Brendan,

 

There are several earlier threads here heavily criticising SQF's requirements concerning Validation (mostly detailed by Myself) and Verification. The continual problem is that a variety of interpretations of Va/Ve exist in the General Literature and within HACCP/GFSI etc etc.

 

SQF claims to base its VA/Ve requirements on "Codex" however its auditorial implementations (notably with respect to Validation) are not compliant to Codex. This misalignment was effectively acknowledged several years ago but the current Guidance afaik remains oblivious to the former.

The practical result is that users of SQF have been obliged to provide appropriate documentation which will be auditorially acceptable. It's as simple as that.

 

It's a sad reflection of the situation that none of the previous Posts mention Codex 2008's Treatise on Validation which afaik is the basis for all subsequent Codex Hygiene-HACCP Revisions..

[Brendan Triplett]

Hi Brendan,

 

There are several earlier threads here heavily criticising SQF's requirements concerning Validation (mostly detailed by Myself) and Verification. The continual problem is that a variety of interpretations of Va/Ve exist in the General Literature and within HACCP/GFSI etc etc.

 

SQF claims to base its VA/Ve requirements on "Codex" however its auditorial implementations (notably with respect to Validation) are not compliant to Codex. This misalignment was effectively acknowledged several years ago but the current Guidance afaik remains oblivious to the former.

The practical result is that users of SQF have been obliged to provide appropriate documentation which will be auditorially acceptable. It's as simple as that.

 

It's a sad reflection of the situation that none of the previous Posts mention Codex 2008's Treatise on Validation which afaik is the basis for all subsequent Codex Hygiene-HACCP Revisions..

 

Hey Charles,

 

Not incredibly inspiring.  It leads me to think that the element is completely up to interpretation and as long as you can argue your methods to the auditor that it will pass since they are a bit confused on it as well.

 

It ends with me thinking that I will gather documentation from peer reviewed resources to build out my validation.  I will use my verification schedule, daily records, and checklists (checking for completeness and accuracy) to complete my verifications.  I will conduct internal audits, based on the SQF provided checklist, to audit the system elements themselves.

 

 

 

 

 

Daily checks and walk throughs are MONITORING activities (unless you mean shadowing the monitoring employee) You CANNOT check your own work

 

 

The evaluation of the person completing the monitoring would be a VERIFICATION  as would review documents for completeness and accuracy  (your onsite could/should be part of the internal audit/reassessment)

 

Internal audit is making sure your program meets GFSI element or code requirements

 

Validation---scientific study to support a hypothesis (in food manufacturing---a PC or CCP generally) that is then proved during VERIFICATION

 

 

"Validation: Obtaining evidence that the elements of the HACCP plan are effective. Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine compliance with the HACCP plan."

https://www.foodprot...14-Brackett.pdf

 

Verification means conducting a review to confirm a process was performed correctly. Verification answers the question "How do you know it actually happened?"

Example: A manager in a cookie factory reviews production records to confirm that the cookies were baked to the temperature described in the recipe.

Validation refers to the requirement that a food processor use scientifically proven methods to control a hazard. Validation answers the question "How do you know it works?"

Example: A food safety manager collects scientific research to demonstrate that the cooking temperature used in the recipe is effective in eliminating harmful bacteria in the raw product.

https://www.fdareade...n-vs-validation

 

 

Scampi, This is incredibly helpful.  Would you be able to look at my verification schedule?  I have it built for system elements, which I believe is correct, but is it not specific enough to cover each PRPs?

 

Thanks everyone for the assistance.

 

Cheers!

[Brendan Triplett]

The Tip Sheet

 

Tip-Sheet-16-Verification-and-Validation.pdf (sqfi.com)

 

Is talking about verification and validation for CCPs.  Am I led to believe that my verification activities and validation activities are focused on the CCPs only?  As Warehouse Distribution our only identified CCP is time and temperature.  This would make this section much shorter.  Something like:

 

• Validation - Studies to show food safe temperatures for normal foodstuffs and seafood.
• Verification - Review of controls to keep temperature within this range and checking records and systems to ensure they maintain this temperature.
• Internal Audit - The SQF provided system element checklist.

Any thoughts on this?  Thanks.

 

Cheers!

[Brendan Triplett]

The Tip Sheet

 

Tip-Sheet-16-Verification-and-Validation.pdf (sqfi.com)

 

Is talking about verification and validation for CCPs.  Am I led to believe that my verification activities and validation activities are focused on the CCPs only?  As Warehouse Distribution our only identified CCP is time and temperature.  This would make this section much shorter.  Something like:

 

• Validation - Studies to show food safe temperatures for normal foodstuffs and seafood.
• Verification - Review of controls to keep temperature within this range and checking records and systems to ensure they maintain this temperature.
• Internal Audit - The SQF provided system element checklist.

Any thoughts on this?  Thanks.

 

Cheers!

 

The code actually says that the GDPs should be on this as well so I answered my own question.  

 

• GDPs
• CCPs
• Changes to the processes

[Scotty_SQF]

Don't forget your prerequisite programs as well that you defined as part of your HACCP Plan.  Those will need verified and validated as well.  Think Pest Control, Foreign Material control, Sanitation, etc.

[Scampi]

I have added system elements into the header of each PRP, and then inserted the elements into an excel spreadsheets with one tab for each element (a handful combined where it makes good sense to do so)

 

I also have a master that combines my regulatory requirements, against the corresponding SQF elements 

 

I perform a very robust annual reassessment (I feel the IA from SQF to be inadequate) that includes reviewing EVERY element on an annual schedule that dictates what is done monthly

 

CCP is re-validated annually

 

Entire program is verified using a summary of key data points

Edited by Scampi, 04 May 2023 - 12:29 PM.

[Brendan Triplett]

Don't forget your prerequisite programs as well that you defined as part of your HACCP Plan.  Those will need verified and validated as well.  Think Pest Control, Foreign Material control, Sanitation, etc.

 

Hey Scotty,

 

These are all part of Module 12 GDPs.  Validating some of these may be difficult.  Scientific information to confirm that pests should stay out of food?  Can the verification that the reports are accurate, and the absence of pests themselves, be a validation of the effectiveness of the program?

 

Cheers

[Charles.C]

Don't forget your prerequisite programs as well that you defined as part of your HACCP Plan.  Those will need verified and validated as well.  Think Pest Control, Foreign Material control, Sanitation, etc.

Hi Scotty,

 

Thks but, unfortunately,  afaik (and just for new potential users of SQF)  the above information is incorrect with respect to Validation although SQF auditors may act otherwise.

 

SQF textually/officially revised their PRP requirements around ver 7.2 due frequent auditorial conflicts. (Documented on this Forum). afail not re-revised since.

[Charles.C]

 

The code actually says that the GDPs should be on this as well so I answered my own question.  

 

• GDPs
• CCPs
• Changes to the processes

 

Hi Brendan,

 

You need to carefully re-read the specific text in 2.5.1 of the Code. (especially note the words "validated, confirmed, effective").

It's only my opinion but, as currently presented, the text might almost be regarded as (unintentional) misinformation..

Understanding of the above requires a look at the historical development of the SQF Code but as is only too obvious old habits sometimes really do "linger on".

 

Regarding the "TIP" I suggest to look at the current validity of the various referred  Sources sprinkled within and at the end of the document.

 

If you wish to see a Valid Codex document on HACCP, I suggest to study the latest (2020) Revision and the Codex Source on Validation referred within.

 

With respect to "Validation" FSIS (2015) introduced their own interpretation which, in a HACCP context, ie -

 

What is HACCP System Validation?
 
Validation is the process of demonstrating that the HACCP system as designed can
adequately control potential hazards to produce a safe, unadulterated product.  
Validation encompasses activities designed to determine whether the entire HACCP
system is functioning as intended.  Validation of a HACCP system involves two
separate elements 1) design and 2) execution.  Under 9 CFR 417.4(a)(1)
establishments are required to assemble two types of supporting documentation
to demonstrate these elements are met:
 
(1)  The scientific or technical support for the HACCP system design (design) - that is
the theoretical principles, expert advice from processing authorities, scientific or
technical data, peer-reviewed journal articles, pathogen modeling programs, or
other information demonstrating that particular process control measures can
adequately prevent, reduce, or eliminate specific hazards; and  
 
(2)  The in-plant validation data (execution) - that is the in-plant observations,
measurements, microbiological test results, or other information demonstrating
the control measures in the HACCP system can perform as expected within a
particular establishment to achieve the intended food safety objective.

 

(1) is designated by FSIS as "Initial Validation" (chronologically set by FSIS at max 90 days after startup).

(2) is designated by FSIS as "ongoing Verification"(chronologically set by FSIS at >90 days after startup)

 

Codex's interpretation of Validation essentially focuses on (1). (minus defined time)

Codex's interpretation of Verification essentiallly focuses on (2) (minus defined time)

 

(afaik) SQF's auditorial interpretation of Validation (despite nominally claimed being "Codex-compliant") accepts (1) and/or(2) thereby blurring the difference between Validation and Verification and generating confusion.

 

 FSIS Compliance Guidelines,Validation.pdf   973.7KB   55 downloads

(afaik still valid but I'm not a FSIS user)

[Scotty_SQF]

Hi Scotty,

 

Thks but, unfortunately,  afaik (and just for new potential users of SQF)  the above information is incorrect with respect to Validation although SQF auditors may act otherwise.

 

SQF textually/officially revised their PRP requirements around ver 7.2 due frequent auditorial conflicts. (Documented on this Forum). afail not re-revised 

Understood, however, I have been through several audits now since that version and have been asked about those.  Normally handled through use of the internal auditing.  In fact, this year I was asked 'You are validating your PRP's through the use of the Internal audit I assume?'.  So, other SQF users should be aware at the very least it may come up during an audit.

[Charles.C]

Understood, however, I have been through several audits now since that version and have been asked about those.  Normally handled through use of the internal auditing.  In fact, this year I was asked 'You are validating your PRP's through the use of the Internal audit I assume?'.  So, other SQF users should be aware at the very least it may come up during an audit.

Hi Scotty,

 

I suggest that a polite response could be something like "Yes,  I am using  recorded  PRP data to confirm (verify?) that the associated  PRPs are effective. (as implied in the Code).

 

As stated in another SQF "TIP", Internal audits are a Verification Tool. 

I also find it sort of (conceptually) unbelievable that the word "Review" appears nowhere in the TIP for Ve/Va.

 

I confess that I had (intentionally?) forgotten that, as illustrated anew in Brendan's current OP, "Verification" has always been such a documentation  Monster for SQF. and seemingly remains so. A simple case of an "Immovable Object". Hopefully Validation has become less entrenched but maybe just wishful thinking.

 

@Brendan - Sorry if yr OP got diverted somewhat from Verification into Validation. This was prompted by my noticing an (interpretive) clash between Va and Ve as illustrated in the use of Internal Audits/Trend Analyses/Reviews in these (apparently) SQF compliant  documents  -

 

 SQF - Validation and Effectiveness.pdf   1.52MB   182 downloads

 SQF - Validation and Verification for Prerequisites.xls   37.5KB   126 downloads

 

(Personally,for Validation, I would have thought it simpler to avoid Philosophical meanderings by simply  "Creating" a "Preliminary" Pilot study (equivalent  to FSIS) using existing data if available or generated if not and then simply apply the "SQF Validation Procedure" to demonstrate Effectiveness. Needs criteria for "effectiveness" of course, eg low/no mice in mouse-traps, etc)

Edited by Charles.C, 09 May 2023 - 02:27 AM.
revised

[Brendan Triplett]

Hey Charles,

 

Thanks for a look at the files.  These look like they are Internal Audits that, once signed off on, act as validation of the PRP.  I am assuming that this type of template could be used for an internal audit of all portions of the food safety program/system?  Verifying step for this would be verifying that the daily walkthroughs and logs are filled out correctly?  This would actually make the entire process a bit easier to wrap my head around if you confirm this.

 

Cheers!

[Charles.C]

Hey Charles,

 

Thanks for a look at the files.  These look like they are Internal Audits that, once signed off on, act as validation of the PRP.  I am assuming that this type of template could be used for an internal audit of all portions of the food safety program/system?  Verifying step for this would be verifying that the daily walkthroughs and logs are filled out correctly?  This would actually make the entire process a bit easier to wrap my head around if you confirm this.

 

Cheers!

Hi Brendan,

 

I should note that I am not a user of SQF so the following comments should be regarded as speculation. Actual users are only too welcome to correct misinterpretations.

As you will have seen from my Post 18, IMO, SQF have created their own interpretation of Va/Ve albeit referenced to Codex's Definitions.

I believe that your above evaluation is basically accurate although SQF carefully avoids specific use of the phrase "Validation of PRPs" for reasons such as already elaborated on this Forum.

I have added 2 more attachments below which may help to understand SQF's handling of Va/Ve and which also illustrate some difficulties incurred. The 1st is a Consultant's analysis addressing the requirements of Sections 2.5.1 - 2.5.2 of SQF9  and the 2nd is the same section material as appeared in SQF 8.1. I have added a red rectangle around one line of 1st attachment to emphasise what, I believe, is a key element of the analysis.

I agree with Tony's earlier comment that the Guidance material in 8.1 is more informative than than that for ver9 so have included 2nd attachment.

It is interesting to note that some "activities" which SQF/8.1 categorised within "Validation/Effectiveness" are now included as "Verification" in SQF's Tip16 for Ver 9. ,eg  Cleaning  and  inspection:  Perform  environmental  testing  to  ensure  that microbiological loads are acceptable. I think this is because the text  for some  "activities" listed in Tip 16  may need "tweaking".

 Analysis of SQF9, Section 2.5.1 and 2.5.2.pdf   1.08MB   59 downloads

 SQF Manufacturing Guidance, 8.1, Section 2.5.pdf   520.37KB   43 downloads

 

IMO  SQF's interpretation of Va/Ve is inferior to say, FSIS, but "It is what it is".

[kingstudruler1]

Hey Charles,

 

Thanks for a look at the files.  These look like they are Internal Audits that, once signed off on, act as validation of the PRP.  I am assuming that this type of template could be used for an internal audit of all portions of the food safety program/system?  Verifying step for this would be verifying that the daily walkthroughs and logs are filled out correctly?  This would actually make the entire process a bit easier to wrap my head around if you confirm this.

 

Cheers!

 

 

Brendan 

 

Most of the verification and validation matrix / programs I create are almost identical to the "sqf verification and validation of prerequisites" that Charles posted in #20.   

 

If I were you, I would use the SQFI checklist as the internal audit.   

 

I would then create a verification / validation matrix that covers the required clauses from the SQF standard.   Much like "sqf verification and validation of prerequisites" mentioned above.  The internal audit could be a source of validation in the matrix.   However, there are probably other sources of validation that you can use as well.  In many cases, I use more than one.  

 

I would probably use a different verification task in most cases than those listed.   in many cases, all you need to do is review the record.

 

For instance.   Line 1 - Raw material/packaging controls and receiving (Id just call this whole thing the approved supplier program and not break it up).   For verification, I would review incoming records to verify we are receiving from an approved supplier, that temperature is checked, etc.  for validation, I think the product testing is fine.   You could also use the ongoing monitoring of suppliers.   even customer complaints.  

[Brendan Triplett]

Kingstud,

 

Were you able to take a look at my OP with the verification schedule?  I am thinking that I should add PRPs to that as recommended.  I am also thinking that you are right; in that I will use the SQF checklist as the internal audit and I will use the sheets that Charles sent me for the verification/validation.  Then I will also have documented peer reviewed info for the CCP validation.  Thoughts?

 

Cheers

[Brendan Triplett]

lol so the SQF - Validation and Effectiveness.pdf that Charles sent is for "Validating" not for verifying.  So, I would have to add the elements in it to the verification schedule, if not already there, and then validate them and the CCP limits.

 

I am going to talk myself through this to try and get some self-clarity.  Anyone please correct me if I am wrong.

 

1. Internal Audits - Pretty simple - I am going to use the SQF provided checklist.
2. Verification - I will use the verification schedule, that I have in OP, and the daily records to verify that the activities are being completed.  Some of the elements do not have records to check but I have methods in my verification schedule that give guidance on how to check those items.  I can put records of all of those checks in our meeting minutes and maintain the other sheets in our files.
3. Validation - I can use the Validation Sheets that Charles sent me for each PRP but also for each major section, not already created by the sheets, as validation paperwork for each major system element group (ie. Management Commitment 2.1, Document Control 2.2, Food Safety System 2.4, etc.).

This is a pretty serious document-heavy part of the process.  BUT  maybe this is it.  Let me know what you all think.  Thanks.

 

Cheers!