12 replies to this topic

[Rosaleen]

Anyone had there audit yet. What are buzz areas - what is everyone doing to validate their prerequisites. Thanks

[AJL]

Following
Also wondering what they expect with validating prerequisites.

[Tony-C]

Hi Rosaleen & AJL,

 

BRCGS Global Standard for Food Safety Issue 9 requirements and guidance for the validation of prerequisites are outlined below.

 

When a prerequisite programme is used to manage a specific hazard, you will need documented validation that the prerequisite programme controls the identified hazard (see the examples given in the guidance).

 

2.2 Prerequisite programmes Clause 2.2.1 Guidance

Although the prerequisite programme is expected to be effective in achieving the level of control required to ensure food safety, it is not a requirement that a documented validation of every prerequisite is undertaken, as prerequisite programmes typically cover a wide range of general environmental controls, often with results that are not quantifiable. However, where a prerequisite programme is used to manage a specific hazard (e.g. cleaning regimes used to prevent allergen cross-contamination), there needs to be a documented validation that the prerequisite controls the identified hazard (see clause 2.7.4 for further details regarding the validation). Some companies prefer to differentiate prerequisites that manage specific hazards from other prerequisites by referring to them as operational prerequisites (oPRPs).

Sites that need to meet the requirements of the US Food Safety Modernization Act (FSMA) should note that they must ensure that preventive controls are subject to validation and verification. Some of these controls may cover activities that have traditionally formed part of the prerequisite programme.

 

Clause 2.7.4

Where the control of a specific food safety hazard is achieved through prerequisite programmes (see section 2.2) or control measures other than critical control points (CCPs; see clause 2.8.1), this shall be stated and the adequacy of the programme to control the specific hazard validated.

 

Clause 2.7.4 Guidance

Examples of prerequisites that require validation include:

• control of allergen cross-contamination by cleaning the production equipment. Evidence is required that the cleaning regime can effectively and consistently remove the allergen (examples of how this might be achieved are given in the guidance to clause 5.3.8).

• chilled storage conditions for product safety. The defined storage temperature must be validated by reference to technical literature, confirming the control of growth of relevant spoilage or food poisoning organisms. The storage facility must be validated as being capable of consistently delivering the defined temperature.

 

Kind regards,

 

Tony

[AJL]

I am curious about this. 

HACCP plans should be validated prior to them being implemented. But for a case of an 'implemented' HACCP plan, a functioning plan can said to be back validated if that makes sense. 

So I am wondering if you can also use this same train of thought and logic /discussion for a  PRP. 

Say for example I used the PRP of cleaning and sanitation as a control for a specific hazard (say gluten allergen). 

This isn't necessarily validated pre implementation, but the verification activities can surely provide a validation? If we have for example years worth of negative swabs/product after change over etc? Could these combined verification activities, combined with an absence of customer complaints etc, be enough evidence to show that the PRP is 'validated'?

 

Otherwise if someone could guide me down the path of doing validation for cleaning after allergens, hit me :)

[Tony-C]

Hi AJL,

 

BRCGS Global Standard for Food Safety Issue 9 requirements for the validation of Allergen cleaning regimes are described in Clause 5.3.8.

 

The verification activities you describe would be acceptable as validation if the swabs/product tests are specific for your allergen (gluten). If they are not specific tests for the allergen then the data would not be regarded as validation that the allergen (gluten) had been removed by the cleaning regime.

 

See 5.3.8 Guidance below

The effectiveness of the procedures must be validated. The validation must be documented and evidence will typically include:

• worst-case production/cleaning trials, where all equipment, processes and allergens need to be considered

• targeted test locations, such as food contact surfaces, difficult-to-clean areas, deadlegs etc.

• targeted samples, where worst-case samples are identified for laboratory testing using suitably sensitive test methods. (Validation tests should be accredited methods and, wherever possible, quantifiable. Rapid tests, ATP and lateral flow devices are good for verification activities but are not suitable for validation.) Possible samples include the first product manufactured in the next production run, rinse water from cleaning systems, swabs etc.

• assessment of new equipment for ease of cleaning prior to purchase

• positive testing of the test method used, to confirm that it will detect the allergen if it is

present in a real sample (i.e. confirmation that product matrix will not interfere with the test).

It is likely that validation data will need to be collected from several production runs to ensure it is representative and complete.

 

Kind regards,

 

Tony

[phantomtrang]

Following 

[Charles.C]

I am curious about this. 

HACCP plans should be validated prior to them being implemented. But for a case of an 'implemented' HACCP plan, a functioning plan can said to be back validated if that makes sense. 

So I am wondering if you can also use this same train of thought and logic /discussion for a  PRP. 

Say for example I used the PRP of cleaning and sanitation as a control for a specific hazard (say gluten allergen). 

This isn't necessarily validated pre implementation, but the verification activities can surely provide a validation? If we have for example years worth of negative swabs/product after change over etc? Could these combined verification activities, combined with an absence of customer complaints etc, be enough evidence to show that the PRP is 'validated'?

 

Otherwise if someone could guide me down the path of doing validation for cleaning after allergens, hit me :)

Hi AJL,

 

This is an extremely "messy" topic particularly from a historical POV.

 

The answer to yr OP is afaik "basically" Yes, but with various caveats, eg it may depend on the specific PRP, for example Allergen Control can be complicated. You should read the, one-off, brilliant allergen cleaning validation procedure offered by SQF in their Standard (maybe ver 8.1).

 

I also suggest you read the chronological aspects of Codex's famous (2008) document defining validation of control measures.

Codex Validation is in Principle necessarily carried out prior to implementation of related control measures.

 

Previously IIRC all the Big 3/4 GFSI-recognised Standards only required Verification of Prerequisites except for SQF who nominally claimed adherence to Codex  but (prior ca. Ver 7) implemented their own interpretation of Codex Validation  similar to the "On-Going" Validation concept as defined by USDA (see lower text). This caused auditorial confusion so that SQF reluctantly amended their instructions to their auditors  that Validation of Prerequisites was no longer formally required, only Verification of effectiveness. However it appears that in Practice many of their auditors have subsequently resisted these changes so that old-style Validation Studies are seemingly still being maintained..

 

USDA exhibit a (silent) Codex work-around involving, IIRC, 2 forms of Validation - "Preliminary" and "On-Going".

 

For unknown (to me) reasons, BRC started formally requiring Validation (presumably Codex) a few years ago. Afaik one, generic, mini work-around so as to be nominally Codex-compliant is to create a "Validation Project" which utilises actual running data to demonstrate "effectiveness".

[Arden]

Is there anything in BRCGS Global Standard for Food Safety Issue 9 that requires annual validation of Allergen cleaning regimes?  If nothing has changed, isn't a one time validation good enough?   

[AJL]

Just been reading this again 🙂
I think I have understood Charles, that I could be compliant by collecting my on going data and stringing it together. I will work on it.
I don't have access to SQF as we are BRC and IFS in our company - but could you share the relevant section without infringing copyright?
Thanks for your response - you always come with valuable suggestions.

[AJL]

And has anyone got a BRC ver. 9 audit story/experience to share? 😉😉

Edited by AJL, 15 February 2023 - 10:01 PM.

[Rosaleen]

what do you think as format. thanks 

Attached Files

•  PRP vailidation .xls   38.5KB   258 downloads

[Tony-C]

what do you think as format. thanks 

 

Hi Rosaleen,

 

I like how you are laying it out but a lot of this appears to be verification.

 

You need to identify the hazard being controlled by the prerequisite programme and limits and have a confirmation that the limits are acceptable (validation).

 

Kind regards,

 

Tony

[Charles.C]

Just been reading this again
I think I have understood Charles, that I could be compliant by collecting my on going data and stringing it together. I will work on it.
I don't have access to SQF as we are BRC and IFS in our company - but could you share the relevant section without infringing copyright?
Thanks for your response - you always come with valuable suggestions.

Hi AJL,

 

Apologies that I never saw yr Post.

 

Problem is that the SQF interpretive issue has been re-ocurring over at least 10 years so the related threads are scattered far and wide.

 

I speculate BRC were running out of ideas for Ver.9 so decided to pull this old chestnut from the History of Validation/Verification. 

 

There are numerous excel sheets within SQF forum compiling Validation Procedures for basic activities such as  GHP, GMP etc The snag is that often Tony's comment in Post 12 is applicable.