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Validation of Pre Requisite Programs

validation prerequisite progrmas PRPs

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#1 NutANDFruitFoodSafety

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Posted 01 June 2020 - 10:22 PM

Hi All - 

 

I am continuing to evaluate our validation activities.

 

I am having a hard time understanding whether or not certain validations are even relevant. For example, in the code under 2.5.1, it says that to validate personnel practices, you could observe employees meeting the requirements of the program. 

 

When I read this, I think okay yes, this would validate that they are carrying out personnel practices. However, when I ask myself, "Does this show that our personnel practices are effective," this type of observation does not actually validate that. What it does validate is that our training is effective in communicating our personnel practices requirements. This goes for any type of observational validation. 

 

Thank you in advance for any feedback.



#2 FurFarmandFork

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Posted 01 June 2020 - 10:35 PM

The language around verification and validation tends to be more fluid than we would like. But here it's somewhat consistent.

 

Language of the code you're referencing:

 

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:
 
i. Good Manufacturing Practices are confirmed to ensure they achieve the required result;
ii. Critical food safety limits are validated, and re-validated annually;
iii. Changes to the processes or procedures are assessed to ensure controls are still effective; and
iv. All applicable elements of the SQF Program are implemented and effective.
 
2.5.1.2 Records of all validation activities shall be maintained.

 

 

 

 

So, your statement above about checking on employees meeting the requirements of the program is a little off. Validations generally establish that, when everything is performed correctly, does it achieve the required result. Not whether it is being performed correctly, which would be a verification activity. (again, this language can be fluid depending on what "level" you are validating things).

 

The relevance in personnel practices or GMP's here would be things like, we have a policy of this type of clothing/gloves/whatever used in these production areas. Will that achieve the desired result in our building? The desired result could be separation of sanitation zones, preventing hair in product, protecting product from personal clothing, whatever. The point is that you have a justification for your policy, and the "validation" of that is really just a review of your program and any data you have to make sure it's working.

 

If we thought that classic "net" hairnets would prevent hair in our product, but annually we looked at hair complaints and saw they were trending up. Then we need to change that program to bouffants or something since even when practiced correctly it does not achieve the desired result. Does that make sense?


Austin Bouck
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Consulting for companies needing effective, lean food safety systems and solutions.

Subscribe to the blog at furfarmandfork.com for food safety research, insights, and analysis.

#3 Charles.C

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Posted 02 June 2020 - 01:45 AM

Hi All - 

 

I am continuing to evaluate our validation activities.

 

I am having a hard time understanding whether or not certain validations are even relevant. For example, in the code under 2.5.1, it says that to validate personnel practices, you could observe employees meeting the requirements of the program. 

 

When I read this, I think okay yes, this would validate that they are carrying out personnel practices. However, when I ask myself, "Does this show that our personnel practices are effective," this type of observation does not actually validate that. What it does validate is that our training is effective in communicating our personnel practices requirements. This goes for any type of observational validation. 

 

Thank you in advance for any feedback.

Hi NFFS,

 

Due its subjectivity, "Validation" per se tends to be a continuously debated topic across all the FS Standards.  Due to their own rather peculiar requirements/interpretations, SQF in particular became embroiled in a bucket- load of audit controversy over Versions prior to 7 which a little searching here of older threads will readily reveal.

 

The outcome in version ca 7 was a revision of the wording of relevant portions of the  Standard and a more or less definitive statement that Prerequisites do not require Validation (similar to some other FS Standards but not all).

 

afaik, the above situation remains unchanged although some SQF auditors may still  cling to the old ways and go along with Validation SOPs drafted as per the older Standards.


Kind Regards,

 

Charles.C


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#4 Tony-C

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Posted 02 June 2020 - 06:00 AM

To add to the useful contributions made by FurFarmandFork and Charkes, I personally find that the requirements for verification and validation of Personnel Practices causes a lot confusion. There is additional confusion by using the terms meeting the requirements and confirming the effectiveness and flipping between verification and validation.

 

2.4.2 Good Manufacturing Practices (Mandatory)

2.4.2 Implementation Guidance

Pre-requisite programs shall be documented and implemented as applicable to the scope of certification. Each applied pre-requisite program must be verified by the SQF practitionerto ensure that it is achieving its intended purpose. The SQF practitioner is required to sign off on each pre-requisite program indicating that the verification has been completed.

2.4.2 Auditing Guidance

Documentation for the pre-requisite programs (PRPs) will be checked at the desk audit. This includes procedures and work instructions applicable to the relevant PRP module(s), or alternative methods of control. The auditor will confirm compliance to this element at the site audit by interview, observation and sampling and checking records. Evidence may include:

• Records of PRP validations are available;

• Personnel practices and processing techniques meet the PRP requirements and the documented procedures.

 

2.5.1 Validation & Effectiveness (Mandatory)

2.5.1 Implementation Guidance

Validation involves testing over and above daily monitoring to ensure that established food safety limits are effective, i.e., achieve the desired results, so that the supplier can have confidence that the product and process are safe.

The supplier must also have documentation showing that the methods and control measures provide the level of control needed. 

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.

 

Clearly the examples above could be described as Verification Activities - 2.5.2 Verification Activities (Mandatory)

 

Guidance for 2.5.1 Validation & Effectiveness (M) includes: 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.

 

Kind regards,

 

Tony



#5 olenazh

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Posted 02 June 2020 - 01:05 PM

Though, we're FSSC certified, I've been doing PRPs validation basing on Codex Alimentarius scheme - working good so far. Please, see attached as a sample. Good luck!

Attached Files



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#6 NutANDFruitFoodSafety

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Posted 02 June 2020 - 03:44 PM

The language around verification and validation tends to be more fluid than we would like. But here it's somewhat consistent.

 

Language of the code you're referencing:

 

 

 

 

So, your statement above about checking on employees meeting the requirements of the program is a little off. Validations generally establish that, when everything is performed correctly, does it achieve the required result. Not whether it is being performed correctly, which would be a verification activity. (again, this language can be fluid depending on what "level" you are validating things).

 

The relevance in personnel practices or GMP's here would be things like, we have a policy of this type of clothing/gloves/whatever used in these production areas. Will that achieve the desired result in our building? The desired result could be separation of sanitation zones, preventing hair in product, protecting product from personal clothing, whatever. The point is that you have a justification for your policy, and the "validation" of that is really just a review of your program and any data you have to make sure it's working.

 

If we thought that classic "net" hairnets would prevent hair in our product, but annually we looked at hair complaints and saw they were trending up. Then we need to change that program to bouffants or something since even when practiced correctly it does not achieve the desired result. Does that make sense?

Thank you for the clarification. So really the validation is a two-fold activity. One, observation that the personnel practices are taking place and then the comparison to any data that would suggest that those practices are or are not working. For example, observing employees wearing hair nets and also the data suggesting zero hair related customer complaints.

 

Is that the way to think of it?

 

Thank you again.



#7 NutANDFruitFoodSafety

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Posted 02 June 2020 - 03:51 PM

Hi NFFS,

 

Due its subjectivity, "Validation" per se tends to be a continuously debated topic across all the FS Standards.  Due to their own rather peculiar requirements/interpretations, SQF in particular became embroiled in a bucket- load of audit controversy over Versions prior to 7 which a little searching here of older threads will readily reveal.

 

The outcome in version ca 7 was a revision of the wording of relevant portions of the  Standard and a more or less definitive statement that Prerequisites do not require Validation (similar to some other FS Standards but not all).

 

afaik, the above situation remains unchanged although some SQF auditors may still  cling to the old ways and go along with Validation SOPs drafted as per the older Standards.

Thank you for the information. This makes a lot of sense and I suppose erring on the side of doing too many validations is probably a safe bet.



#8 NutANDFruitFoodSafety

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Posted 02 June 2020 - 03:54 PM

Guidance for 2.5.1 Validation & Effectiveness (M) includes: 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.

 

 

This is exactly the text that causes confusion for me. I am unsure how I would be able to determine effectiveness through observing somebody carrying out a practice. That sounds a lot more like verification to me.

 

Thank you all for the help!



#9 FurFarmandFork

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Posted 02 June 2020 - 06:02 PM

Thank you for the clarification. So really the validation is a two-fold activity. One, observation that the personnel practices are taking place and then the comparison to any data that would suggest that those practices are or are not working. For example, observing employees wearing hair nets and also the data suggesting zero hair related customer complaints.

 

Is that the way to think of it?

 

Thank you again.

 

I think you've got it. Like I said, don't get hung up on the language you choose to use. For all your food safety requirements and tools, you need to be able to justify that they will work as intended when working properly (usually referred to as a "validation"), and you need a method in place to independently check that they are currently being carried out as intended (typically referred to as verification).

 

Validation: Hey, the way we're going to do this is going to work (justification)

Verification: Is it working/are we still doing it properly?

 

Depending on what layer of policy you're examining, they can be fluid. A verification that you're carrying out GMP's could subsequently provide validation data that your training program is effective as written. It's a tangled web sometimes :)


Austin Bouck
Owner/Consultant at Fur, Farm, and Fork.
Consulting for companies needing effective, lean food safety systems and solutions.

Subscribe to the blog at furfarmandfork.com for food safety research, insights, and analysis.

#10 NutANDFruitFoodSafety

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Posted 02 June 2020 - 08:22 PM

I think you've got it. Like I said, don't get hung up on the language you choose to use. For all your food safety requirements and tools, you need to be able to justify that they will work as intended when working properly (usually referred to as a "validation"), and you need a method in place to independently check that they are currently being carried out as intended (typically referred to as verification).

 

Validation: Hey, the way we're going to do this is going to work (justification)

Verification: Is it working/are we still doing it properly?

 

Depending on what layer of policy you're examining, they can be fluid. A verification that you're carrying out GMP's could subsequently provide validation data that your training program is effective as written. It's a tangled web sometimes :)

Wonderful. Thank you so much! 

 

Thanks to everyone for the help.



#11 Charles.C

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Posted 05 June 2020 - 03:27 AM

A lot of confusion in this thread. Simply illustrates how SQF previously agreed to have caused auditee confusion and even now have insufficiently rewritten the text.

 

And I fear the previous posts are still confused since nobody has emphasised the chronological aspect of Validation. This is operationally  "critical:" as explained at length in Codex (2008) which has elsewhere supplanted SQF's ageing Glossary text. I imagine this is why SQF auditors may also occasionally be confused also..

 

@Olena -afaik  iso22000 does not require validation of PRPs and never has done. Similarly to SQF (as from version7).

 

@NFFS - Yr comment in Post 8 was exactly correct although I think you may ultimately have concluded the opposite. SQF are essentially stating that PRPs only need to be verified (= confirmed).

 

These 2 documents are the most lucid texts on FS Validation which I'm aware of -

 

Attached File  Codex 2008 guidelines for validation of FS control measures,2008.pdf   206.81KB   21 downloads

Attached File  FSIS compliance guideline,2015 - HACCP_Systems_Validation.pdf   973.77KB   25 downloads


Edited by Charles.C, 05 June 2020 - 03:37 AM.
added

Kind Regards,

 

Charles.C


#12 NutANDFruitFoodSafety

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Posted 08 June 2020 - 05:40 PM

A lot of confusion in this thread. Simply illustrates how SQF previously agreed to have caused auditee confusion and even now have insufficiently rewritten the text.

 

And I fear the previous posts are still confused since nobody has emphasised the chronological aspect of Validation. This is operationally  "critical:" as explained at length in Codex (2008) which has elsewhere supplanted SQF's ageing Glossary text. I imagine this is why SQF auditors may also occasionally be confused also..

 

@Olena -afaik  iso22000 does not require validation of PRPs and never has done. Similarly to SQF (as from version7).

 

@NFFS - Yr comment in Post 8 was exactly correct although I think you may ultimately have concluded the opposite. SQF are essentially stating that PRPs only need to be verified (= confirmed).

 

These 2 documents are the most lucid texts on FS Validation which I'm aware of -

 

attachicon.gif Codex 2008 guidelines for validation of FS control measures,2008.pdf

attachicon.gif FSIS compliance guideline,2015 - HACCP_Systems_Validation.pdf

Thank you this is very helpful. 

 

It sounds like PRPs are basically treated as already validated based on the common knowledge that they do work and everyone more or less has similar experience in having PRPs.

 

So PRPs need verification based on the assumption that PRPs are common knowledge and considered validated based on industry common standards and practices. 



#13 Charles.C

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Posted 08 June 2020 - 07:48 PM

Thank you this is very helpful. 

 

It sounds like PRPs are basically treated as already validated based on the common knowledge that they do work and everyone more or less has similar experience in having PRPs.

 

So PRPs need verification based on the assumption that PRPs are common knowledge and considered validated based on industry common standards and practices. 

Hi NFFS,

 

SQF's interpretation of Validation and Verification has had a chequered history. (not a unique occurrence though)

 

This statement appeared on SQF website 3 years ago after, from memory, issue of version 7 which contained substantial text changes and which generated considerable internal discussions within SQF  -

 

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?

 

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 transition is illustrated in this 2017 thread indicating that many SQF auditors (and auditees) were unfamiliar with the changes.

 

https://www.ifsqn.co...tc/#entry109383

 

Unfortunately, even now, afai can see the text in the Guidance has in some places simply failed to catch up with the changes, for example the audit Guidance under clause 2.4.2 -

 

Records of PRP validations are available;

 

As noted in previous Posts of this thread the Guidance under 2.5.1  is now clearly separated into "Validation of CCPs" and "Effectiveness of PRPs"

 

Elsewhere, as you observed in post 8,  "Effectiveness" would typically be designated as "Verification".

 

In practice, despite their name, PRPs are often defined after a process is running. If "Validation" is required (other Standards), a hypothetical test "project" needs to be invoked (note SQF's mention of "in-house or laboratory challenge studies") to conform to the chronological aspect. This "project" for PRPs  typically involves risk assessment /  activities "similar" to those already being undertaken routinely for confirming the PRP's effectiveness.

 

The Guidance not surprisingly has no mention of PRPs in Verification clause 2.5.2


Kind Regards,

 

Charles.C






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