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#1 Jessamine

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Posted 04 May 2007 - 06:21 AM

Dear BRC users,

Regarding the following BRC – Food clauses

5.1.1 Where processing is undertaken to ensure product safety, legality and quality, a full validation of the process shall be made prior to initial production ensuring worst-case conditions are considered.


5.1.2 Ongoing process validation shall be undertaken on a routine basis based on risk assessment and the receipt of data indicating inconsistent or insufficient compliance with process requirements.


Anyone can give examples on how to carry out validation? what is the difference between the “ongoing validation” and the regular product inspection and analysis which verifies the safety, legality and quality of the product for each product batch/lot? and what is the difference between the "ongoing validation" and the regular monitoring of the process parameters (CCPs or others)?

Don't you think it is a redundant requirement? where is the addition?

Edited by Jessamine, 04 May 2007 - 06:31 AM.

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#2 Charles.C

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Posted 06 May 2007 - 10:39 AM

Dear Jessamine,

It does appear that BRC are making their standard progressively more difficult to understand, perhaps to compete with ISO ? :smile:

You may get more specific help if you describe yr product / process.

For general purposes, I can suggest - “PROPOSED DRAFT GUIDELINES FOR THE VALIDATION OF FOOD SAFETY
CONTROL MEASURES” (2006) at
ftp://ftp.fao.org/codex/ccfh38/fh38_08e.pdf

or for HACCP itself – “Validation and Verification of HACCP” (2001) at
http://europe.ilsi.o...le/ILSIVali.pdf

(or ISO22000).

This HACCP one (American) is shorter and more practical oriented –
http://www.food-mana...m/article/14007

The above all focus on food safety but the principle is general.

Rgds / Charles.C


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#3 Jessamine

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Posted 11 May 2007 - 08:52 AM

Thank you Charles for the useful links and sorry for late reply.

The validation of the BRC is a sub-clause of the clauses:

5 Process Control

5.1 Control of Operations

It is different from the validation of HACCP stated in the Clause 1 HACCP System

I strongly believe that this clause is borrowed from the following ISO 9001:2000 sub-clause:

7.5 Production and service provision

7.5.2 Validation of processes for production and service provision

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

Validation shall demonstrate the ability of these processes to achieve planned results.

The organization shall establish arrangements for these processes including, as applicable

a) defined criteria for review and approval of the processes,

b) approval of equipment and qualification of personnel,

c) use of specific methods and procedures

d) requirements for records (see 4.2.4), and

e) revalidation.

As you read, it is for production processes that can not be verified for conformance before the product has been used and destructive tests are required for validation. The BRC standard does not provide sufficient information about what they mean by validation. From my point of view it is a poor standard compared with ISO ones. Unless BRC writers give us an explanation. Do we have to know the ISO 9001 standard to understand the BRC standard?


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#4 Charles.C

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Posted 11 May 2007 - 02:00 PM

Dear Jessamine,

I think some of the confusion in this section is a result of (attempted) rationalisations and expansions from the previous version (which was already messy) + the customary uncertainty over the inter-usage of VER/VAL .

As you just noted, some of the repetition is from sub-clausing. Additionally, it seems logical that where processing steps are related to the product safety, they will have been studied under one’s HACCP requirements already ?

The fact is that the topic of how to interpret and apply “validation” has a substantial history here and elsewhere. As per yr comment, I guess variations are acceptable as long as you make clear yr specific situation and are then consistent. Easy to say but :whistle:
I think I understand yr ISO9k linkage (not a user myself) but I rather doubt that BRC are trying to narrow the requirements as you hope (?), more likely the opposite IMO, however any BRC auditor around is welcome to correct me.
My evaluation : net result = demand for increased information, such is continuous improvement. :headhurts:
The next version will probably be even worse. *gloom*

Rgds / Charles.C


added – if you are interested to see how various organisations (USFDA, Codex etc) interpret HACCP validation and verification can try this link which compares them in a table, pgs 288-291. the index page (401) also has other applications of their use (successive pages obtained by clicking within the shown page).

http://books.nap.edu...cified Page.y=8

added (2) - to illustrate a few applications I extracted the following examples (not all from the food trade) -

(1) 7.2 A cleaning validation protocol should describe the procedure used to validate the cleaning process. It should include in addition to other information: description of the equipment used; interval between the end of production and the beginning of the cleaning procedures; cleaning procedures to be used for each product, each manufacturing system or each piece of equipment; sampling procedures with rationales; analytical methods including limit of detection and limit of quantitation; acceptance criteria with rationales and conditions for re-validation.
(pharmaceutical industry - http://www.hc-sc.gc....ettoyage_e.html )

(2) The processor should have specifications from the pouch supplier for sealing bar temperature, pressure and dwell time necessary to obtain a good seal. Using these specifications, it is important that the processor first validate the heat sealer by running several filled pouches through the sealer, followed by burst testing. During production, monitoring the sealing bar temperature, pressure and dwell-time and carrying out burst testing on a regular basis will demonstrate that the specifications are achieved on a continuous basis.
(food retortable pouch - http://www.inspectio...ac/chap3e.shtml )


(3) The FDA defines process validation as follows:
Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.
It is important that the manufacturer prepare a written validation protocol which specifies the procedures (and tests) to be conducted and the data to be collected. The purpose for which data are collected must be clear, the data must reflect facts and be collected carefully and accurately. The protocol should specify a sufficient number of replicate process runs to demonstrate reproducibility and provide an accurate measure of variability among successive runs. The test conditions for these runs should encompass upper and lower processing limits and circumstances, including those within standard operating procedures, which pose the greatest chance of process or product failure compared to ideal conditions; such conditions have become widely known as "worst case" conditions. (They are sometimes called "most appropriate challenge" conditions.) Validation documentation should include evidence of the suitability of materials and the performance and reliability of equipment and systems.
(Medical devices - http://www.fda.gov/C...GUIDANCE/pv.htm )

(4) http://www.thenfl.co...dies_Layout.pdf
(General article on validation of selected food safety processes particularly via challenge tests)


Edited by Charles.C, 12 May 2007 - 05:49 PM.

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#5 Charles.C

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Posted 13 May 2007 - 09:12 PM

Dear Jessamine,

Just in case you were disturbed by the complexity of the non-food interpretations of validation (impressive but I’m sure in excess of BRC food requirements ), here is one more rather nice example showing some detailed validation steps in the manufacture of shelf-stable pumpkin pie. I think it partly answers (at least for pumpkin) yr comment that there is a lack of clearly specified expectations for validation. In general you are correct IMHO.

Attached File  pumpkin_pie_.pdf   153.12KB   486 downloads

Rgds / Charles.C


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#6 Jessamine

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Posted 19 May 2007 - 05:51 PM

Many thanks Charles for the attachment. For the paragraph entitled “Criteria 4: Microbial Analysis for Process Validation”. I can ask again, what is the difference between this validation and the regular product inspection and analysis (BRC clause 4.5)? It’s a redundant requirement.



4.5 Product Inspection and Analysis

The company shall undertake or subcontract product inspection and analyses which are critical to confirm product safety, legality and quality, using appropriate procedures, facilities and standards.”



Anyone who passed an EFSIS BRC audit could give an explanation?
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#7 Simon

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Posted 22 May 2007 - 08:30 AM

Many thanks Charles for the attachment. For the paragraph entitled “Criteria 4: Microbial Analysis for Process Validation”. I can ask again, what is the difference between this validation and the regular product inspection and analysis (BRC clause 4.5)? It’s a redundant requirement.



4.5 Product Inspection and Analysis

The company shall undertake or subcontract product inspection and analyses which are critical to confirm product safety, legality and quality, using appropriate procedures, facilities and standards.”



Anyone who passed an EFSIS BRC audit could give an explanation?

Can anyone help Jessamine with this enquiry? :dunno:
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#8 cazyncymru

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Posted 31 May 2007 - 09:34 PM

Many thanks Charles for the attachment. For the paragraph entitled “Criteria 4: Microbial Analysis for Process Validation”. I can ask again, what is the difference between this validation and the regular product inspection and analysis (BRC clause 4.5)? It’s a redundant requirement.



4.5 Product Inspection and Analysis

The company shall undertake or subcontract product inspection and analyses which are critical to confirm product safety, legality and quality, using appropriate procedures, facilities and standards.”



Anyone who passed an EFSIS BRC audit could give an explanation?



yep

what it means is that you either have to employ an independant laboratory to carry out testing, as set out in the micro regs, or ensure that you if test the product yourself, you test them to the current bs method at the required frequency again as set out in the micro regs 2007.
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#9 Charles.C

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Posted 01 June 2007 - 07:14 AM

Dear Cazx,

Does the “yep” mean you agree it’s redundant ?

I guessed the conceptual answer to Jesssamine’s question might be that BRC found themselves stuck in layout problems since the validation is referring to the [Process] (hence Section 5) whereas the 4.5 is aimed at the [Product] (hence Section 4) although, as noted, one is effectively linked to the other (I think, what a mess !!)

Yr “bs” comment looks very useful but appeared to require injection of money :crying: when I followed it up, can you give any more practical detail in this finite space?

Rgds / Charles.C


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#10 cazyncymru

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Posted 04 June 2007 - 11:51 AM

Dear Cazx,

Does the “yep” mean you agree it’s redundant ?

I guessed the conceptual answer to Jesssamine’s question might be that BRC found themselves stuck in layout problems since the validation is referring to the [Process] (hence Section 5) whereas the 4.5 is aimed at the [Product] (hence Section 4) although, as noted, one is effectively linked to the other (I think, what a mess !!)

Yr “bs” comment looks very useful but appeared to require injection of money :crying: when I followed it up, can you give any more practical detail in this finite space?

Rgds / Charles.C



Sorry to mislead you Charles but I didn't mean yes i think its redundant!

Lab testing should as far as possible based on British Standard test method. if you look at the Micro Criteria they will quote the BS (British Standard) method that you should use.
If you were testing for acidity of cream you would base your test method on BS 1741:part 10 section 10.2 1989

Salmonella (which is a legal and a product safety issue) should be tested against BS 4285 section 3.9 1987

hope this clears it up!

c x
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#11 Jessamine

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Posted 06 June 2007 - 12:04 PM

Dear Cazx,

The independent analysis that you have referred to is a requirement according to the following clause:



“4.5.2 Where the company undertakes analyses which are critical to product safety or legality, the laboratory, or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO 17025.


4.5.3 Procedures shall be in place to ensure reliability of laboratory results, other than those specified in 4.5.2.”


These procedures include the independent laboratory analysis.


Do you still not agree with me it’s redundant?
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#12 cazyncymru

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Posted 08 June 2007 - 09:08 AM

Dear Cazx,

The independent analysis that you have referred to is a requirement according to the following clause:



“4.5.2 Where the company undertakes analyses which are critical to product safety or legality, the laboratory, or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO 17025.


4.5.3 Procedures shall be in place to ensure reliability of laboratory results, other than those specified in 4.5.2.”


These procedures include the independent laboratory analysis.


Do you still not agree with me it’s redundant?



No it is not redundant

Reading the clause , which is a fundamental clause, it is saying that

If you have to test a product or subcontract that testing and that the test carried out is critical to product safety , legality or quality, then you need to use a lab and lab methods that can demonstrate that they can obtain confident results using a method that may be decided by a piece of legislation ie the micro regs or an approved British Standard (or ISO) method.

The sub sections of this clause are almost elaborating on this, and I would say that it is them that are redundant.

We have a BRC Audit on Tuesday, and I will ask them for their interpretation.
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#13 Simon

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Posted 08 June 2007 - 09:16 AM

We have a BRC Audit on Tuesday, and I will ask them for their interpretation.

I know you won't need it, but good luck. :thumbup:

Simon
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#14 Charles.C

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Posted 08 June 2007 - 11:21 AM

Dear Cazx,

Yes, good luck and don't forget the nice meal on the house. :smile:

Rgds / Charles.C


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#15 Jessamine

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Posted 17 June 2007 - 03:33 PM

Dear Cazx
Please feedback with your auditor's reply.

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