12 replies to this topic

[steve@padrinofoods.com]

Anyone have any ideas on how to validate the other items in Module 11 besides employee practices?  Any feedback would be appreciated!

 

We had a minor for 2.5.1.1 Validation.  The auditor said that we "did not address all elements of Good Manufacturing Practices in Module 11,"  and she said that although we looked at employee practices GMP's we did not address other GMP's in Module 11   Thanks,

 

 

[G M]

Anyone have any ideas on how to validate the other items in Module 11 besides employee practices?  Any feedback would be appreciated!

 

We had a minor for 2.5.1.1 Validation.  The auditor said that we "did not address all elements of Good Manufacturing Practices in Module 11,"  and she said that although we looked at employee practices GMP's we did not address other GMP's in Module 11   Thanks,

 

 

2.5 SQF System Verification

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.

 

Have a schedule for reviewing your safety programs with a frequency and who is responsible for doing it, and have some basic documentation stating which parts are reviewed and when.

 

Likely this is something you are doing, if not more often at least in preparation for the audit.  I would have to guess the procedure and record of completion is just missing.

[Scampi]

I have a daily GMP inspection record 

 

it looks not only at employees but

 

visitors

doors closed tightly

maintenance staff activities

how raw/finished goods and chemicals are stored

open wounds are covered

utensils etc are in good repair and stored in the correct areas

nothing directly on the floor

 

etc etc

[Charles.C]

Anyone have any ideas on how to validate the other items in Module 11 besides employee practices?  Any feedback would be appreciated!

 

We had a minor for 2.5.1.1 Validation.  The auditor said that we "did not address all elements of Good Manufacturing Practices in Module 11,"  and she said that although we looked at employee practices GMP's we did not address other GMP's in Module 11   Thanks,

Hi Steve,

 

Unfortunately this aspect of SQF is a perennial source of confusion due SQF history.

 

Try this thread for some practical clarification of SQF's "intentions", especially maybe FurFarmxxx posts -

 

https://www.ifsqn.co...ms/#entry160902

 

Additionally the attached file in this Post may be helpful -

 

https://www.ifsqn.co...nt/#entry189001

[paulwill10124]

Your GMP (or cGMP) should cover the five Ps of Good Manufacturing Process.  In case you're not sure what they are, here's the list:

 

1. People - ensuring that the people adhere to GMP and regulations and ensuring they understand their roles and responsibilities
2. Products - ensuring products are to spec and that the raw materials are fit for purpose
3. Processes - should be clearly documented and available to all employees; processes should also be reviewed regularly to ensure that they are efficacious
4. Procedures - should be set out consistently and clearly as a set of instructions; any deviations from the standard should be documented
5. Premises - need to promote cleanliness, avoid cross-contamination and cross-contact; equipment should be located and calibrated to ensure that they are fit for purpose

If it will help, I will dig out an old training guide on GMP that I wrote some time ago.

[Charles.C]

Your GMP (or cGMP) should cover the five Ps of Good Manufacturing Process.  In case you're not sure what they are, here's the list:

 

1. People - ensuring that the people adhere to GMP and regulations and ensuring they understand their roles and responsibilities
2. Products - ensuring products are to spec and that the raw materials are fit for purpose
3. Processes - should be clearly documented and available to all employees; processes should also be reviewed regularly to ensure that they are efficacious
4. Procedures - should be set out consistently and clearly as a set of instructions; any deviations from the standard should be documented
5. Premises - need to promote cleanliness, avoid cross-contamination and cross-contact; equipment should be located and calibrated to ensure that they are fit for purpose

If it will help, I will dig out an old training guide on GMP that I wrote some time ago.

Hi Paul,

 

Thks input.

 

Actually SQF defines the Scope in some detail, eg -

 SQF-GMP.PNG   37.9KB   0 downloads

The Handicap (I think) (typically for SQF)  is the Validation.

[Charles.C]

Anyone have any ideas on how to validate the other items in Module 11 besides employee practices?  Any feedback would be appreciated!

 

We had a minor for 2.5.1.1 Validation.  The auditor said that we "did not address all elements of Good Manufacturing Practices in Module 11,"  and she said that although we looked at employee practices GMP's we did not address other GMP's in Module 11   Thanks,

Hi Steve,

 

Sorry that I omitted to emphasize that IIRC, Validation, per se, for most (all?) GMP/Prerequisite programs is currently not required by SQF.  It is necessary to read the Standard's (et al) text with considerable care/caution. There are previous threads here discussing this issue.

 

Also see Tip Sheet 16 for Ver. 9. -

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

(Some FS Studies  might regard  the "blue" as a Verification activity in a routine scenario).

 

An appropriate response to your Auditor's comment may require a little more context.

 

I have never implemented  SQF so contrarial opinions to above are Welcome.

[Scotty_SQF]

Spell out how you are validating your GMP's using metrics by utilizing your verification of GMP's.  For example, you are probably using internal audits to verify conformance to GMP's, so in turn a way to validate this would be that you expect in a year/quarter (you define frequency) to have say 5 or less minor discrepancies due to GMP's noted during your internal audit.  Then at a defined frequency, say yearly or quarterly, you are checking the results of your GMPs as it relates to the internal audits and validating  those results by hopefully showing you had 5 or less minors.  I developed and use Validation Summary sheets to document this.  I also have in there a metric for Third party audits and customer complaints.

[Charles.C]

Spell out how you are validating your GMP's using metrics by utilizing your verification of GMP's.  For example, you are probably using internal audits to verify conformance to GMP's, so in turn a way to validate this would be that you expect in a year/quarter (you define frequency) to have say 5 or less minor discrepancies due to GMP's noted during your internal audit.  Then at a defined frequency, say yearly or quarterly, you are checking the results of your GMPs as it relates to the internal audits and validating  those results by hopefully showing you had 5 or less minors.  I developed and use Validation Summary sheets to document this.  I also have in there a metric for Third party audits and customer complaints.

Hi Scotty,

 

Tks for input. I deduce you are documentarily validating your GMP-PRPS.

 

The basis for my Post7 is a Q/A statement on SQF Website quoted in this (2017) Post which followed major changes in SQF Ver 7 -

https://www.ifsqn.co...tc/#entry109513
 

Q - Why are PRPs not required to be validated? Instead, they are required to be verified as described in 2.5.2.4. Can you provide clarification as to whether PRP’s require formal validation?

 

A - The term “validation” specifically applies to control limits and requires scientific analysis to demonstrate that control limits are effective. Based on advice from our stakeholders, we reworded the requirement for pre-requisite programs to state that the PRPs be “confirmed to ensure they achieve the required result rather” than “validated.” The intent is to clarify the intent of the Code so that the effectiveness of the PRP is being met

 

The related text remained essentially unchanged through versions 7, 7.2, 8.1 however i do note a possibly interesting, 1-word change in Ver9., ie -

 

(Ver, 8.1)

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 ensure that:

1. Good Manufacturing Practices are confirmed to ensure they achieve the required result;
2. ii.  Critical food safety limits are validated, and re-validated annually;

 

(Ver. 9)

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

 

 

 

Nonetheless the Guidance in Ver 9 seems unchanged from 2012, eg compare (7.2) text below to that in Post7 above-

 

(Ver 7.2)

 

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

 

 

My impression is that the quote in Post 7 is simply reiterating the situation which existed 2012-2020 that "validation" is being reserved for critical control/quality limits but if the mentioned change in 2nd quote above is intended to represent SQF  (silently?) re-defining the situation for GMPs, so be it.

 

Can you (or anyone) clarify the terminological situation ?

Edited by Charles.C, 21 September 2022 - 08:33 PM.
edited

[G M]

...

My impression is that the quote in Post 7 is simply reiterating the situation which existed 2012-2020 that "validation" is being reserved for critical control/quality limits but if the mentioned change in 2nd quote above is intended to represent SQF  (silently?) re-defining the situation for GMPs, so be it.

 

Can you (or anyone) clarify the terminological situation ?

 

I would agree that the expectation has not changed over the last few versions, and the phrase "The methods shall validate" is implying the kind of scheduled analytical review of GMP verification activities Scotty described.

[Charles.C]

I would agree that the expectation has not changed over the last few versions, and the phrase "The methods shall validate" is implying the kind of scheduled analytical review of GMP verification activities Scotty described.

Hi GM,

 

As I understand you are opining that the usages of "validate" in the directly above quote and in the sentence <<< Spell out how you are validating your GMP's using metrics by utilizing your verification of GMP's >>> in Post 8  are "colloquial" rather than to be  interpreted in a Validation vs Verification context.

[Scotty_SQF]

Maybe I reworded what I do wrong?  I'm not sure, all i know is the approach I described I have done and actually received a glowing review from our auditor on it. Now that was one auditor and who knows what the next one will say. 

 

I used to say we validated such programs through the use of internal audits and that was always shaky during audits.  Received a lot of questions from auditors on it and was just a lot of explaining.  I consulted and auditor friend of mine and they mentioned that I need to define how the use of audits and observations are showing that what we have in place is working.  I asked if we defined metrics (like I described above in my post) and used the audits and observations in turn to show that the results were within defined metrics would that help, and the response was 'now you are understanding what they are most likely looking for to link your validating of programs through the use of audits and observations'.  Switched to doing it that way and documenting it and have had no questions.

 

Everyone needs to find a way that works best for them, their audit scheme, their program and their company.  We all know how different auditors react to different things.  So what worked this year for one auditor, may not work next year for a different one.

[Charles.C]

Maybe I reworded what I do wrong?  I'm not sure, all i know is the approach I described I have done and actually received a glowing review from our auditor on it. Now that was one auditor and who knows what the next one will say. 

 

I used to say we validated such programs through the use of internal audits and that was always shaky during audits.  Received a lot of questions from auditors on it and was just a lot of explaining.  I consulted and auditor friend of mine and they mentioned that I need to define how the use of audits and observations are showing that what we have in place is working.  I asked if we defined metrics (like I described above in my post) and used the audits and observations in turn to show that the results were within defined metrics would that help, and the response was 'now you are understanding what they are most likely looking for to link your validating of programs through the use of audits and observations'.  Switched to doing it that way and documenting it and have had no questions.

 

Everyone needs to find a way that works best for them, their audit scheme, their program and their company.  We all know how different auditors react to different things.  So what worked this year for one auditor, may not work next year for a different one.

Hi Scotty,

 

I agree with the ending of yr 2nd paragraph above except, predictably, for the one word highlighted in "blue".

 

The discussion that has been revolving in this thread has now been repeated several times in the last few years and every time seems to ultimately reach the same sad conclusion as noted in yr last paragraph.

 

The cause of all this confusion should IMO definitely not be laid on you. IMO the buck stops with "SQF" due their implementation of the SQF Standard and, seemingly, their inability to "standardize" their Auditors over the handling of this topic.

 

This (Codex Validation 2008) re-quote was also contained in the (2017) post linked in Post 9 -

 

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  (see  section  VII).  Validation  of  control  measures  is,  whenever possible, performed before their full implementation.

There  is  often  confusion  among  the  concepts  of  validation,  monitoring  and  verification.   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.  Monitoring and verification are the tools  used  to  check  whether  the  control  measures  are  being  adhered  to  and  to  demonstrate  that  they  are operating as intended.

(The remainder of the previously linked Post contains a detailed analysis of this, seemingly, infinitely recurring, SQF Auditorial Issue).

 

The relevance of Internal Audits should IMO be interpreted within the chronological context of above re-quotation.

 

"Nuff said" I guess.

 

PS - JFI I noticed this short article comparing "Validation of PRPS" in BRC, SQF, FSMA which illustrates some differences. One odd aspect is zero mention of Codex, ie article is presumably US oriented.

https://fsns.com/req...isite-programs/

 

PPS -

It was not discussed in previous Posts of this thread but one further consequence of SQF essentially ignoring Codex's chronological distinction between Validation/Verification is to create confusion over responses to Section 2.5.2, eg this near-Horror Story -

https://www.ifsqn.co...es/#entry130802