13 replies to this topic

[22000]

8.2 Validation of control measure combinations

Prior to implementation of control measures to be included in operational PRP(s) and the HACCP plan and after any change therein (see 8.5.2), the organization shall validate (see 3.15) that

a) the selected control measures are capable of achieving the intended control of the food safety hazard(s) for which they are designated, and

b) the control measures are effective and capable of, in combination, ensuring control of the identified food safety hazard(s) to obtain end products that meet the defined acceptable levels.

If the result of the validation shows that one or both of the above elements cannot be confirmed, the control measure and/or combinations thereof shall be modified and re-assessed (see 7.4.4).

Modifications may include changes in control measures (i.e. process parameters, rigorousness and/or their combination) and/or change(s) in the raw materials, manufacturing technologies, end product characteristics,methods of distribution and/or intended use of the end product.

Does it mean I do not change any part until full cause an effect is known. Am I simple.
How to show this to an auditor?

Edited by 22000, 07 March 2011 - 02:50 PM.

[Charles.C]

Dear SS2010,

Not exactly sure what you mean by "change any part" since this element is supposed to come before implementation.
Anyway, the simple answer is yes.
One answer to the second question is more or less identical to my post in the recent analogous thread in the SQF2000 forum. Details are also elaborated in iso22004.

Rgds / Charles.C

[22000]

Sorry I mean part = ingredient, formulation, procedure, machine on own or combination.

[Charles.C]

Dear SS2010,

The basic answer is identical - first paragraph of your 8.2 quote.

Rgds / Charles.C

[Tony-C]

Does it mean I do not change any part until full cause an effect is known. Am I simple.
How to show this to an auditor?

Yes - normally I would use a "Process Change Approval System" to manage this.

Regards,

Tony

[Simon]

Yes - normally I would use a "Process Change Approval System" to manage this.

Regards,

Tony

I would be interested in seeing a procedure or description of that system. Never seen one on here before.

Regards,
Simon

[GMO]

Yep, before any change, you should consider whether the change should be referred to the HACCP team and consider whether the CCPs and PRPs are still sufficient to control all the hazards. It's logical when you think about it, because you need to ensure any ongoing change is safe. Sorry I can't post a procedure, I don't have access to any of my old procedures anymore.

[Charles.C]

Dear All,

Actually I do have a little sympathy for SS2010 after re-reading the standard’s section 8.2. The wording IMO is clumsy and poor. And the pointer to 8.5.2 (improvement) IMO further boosts the confusion.

The logic of validating the relevant CMs in the initial set-up before routine use of the system is self-explanatory (I think). However although the same procedure would logically also follow for a change within routine use of the process, the reality is that changes may just “happen” (eg thanks to the hidden power of Production ). I suspect that ISO is quietly accepting such possibilities and specifying a follow-up.

ISO 22004 contains this paragraph in the guidance for 8.2 which somewhat dilutes the original IMO –

If additional control measures, new technology or equipment, changes in the control measures, product (recipe) changes, identification of new or emerging hazards or changes in their frequency of occurrence, or unexplained failures of the system occur, revalidation of the system might be necessary.

The "might" is debatable. Many haccp programs would include some of the previous quote within their verification program also.

(And the reality is that it is not impossible that a process may be cheerfully put on-line without any validation [Production rules!] but in this case the Codex procedure referred in SS2010’s other thread does offer a [ textual] correction for such stupidity)

Rgds / Charles.C

[Charles Chew]

Dear All,
Generally for initial system validations, we perform this requirement base on prospective and concurrent validation data. When control measures combinations are satisfactorily supported to deliver the level of acceptable FSO, the system is considered effectively implemented until circumstances under Clause 8.5.2 applies where in this situation, retrospective implementation data or jointly with new applicable prospective would be needed for system revalidation. (Key is certainly a good understanding of system validation and control measure combination)

[Tony-C]

A design and development section in the standard could have clarified a lot of this and removed quite a lot of confusion.

[22000]

Thank you for your contnuing support, it helps me.

[22000]

Sorry. can any firned share a template or not.

[Modarres]

Does it mean I do not change any part until full cause an effect is known. Am I simple.
How to show this to an auditor?

Validation should done when:
1. first determination of control measures,
2. changing control measures.
You should do validation for both:
1. each control measure,
2. control measures combination.
see guidance as attachment.

Attached Files

•  Guideline for the Validation of Food Safety Control Measures.pdf   170.26KB   201 downloads

[22000]

Sorry for my bad reponse to previous post and doc atatched.
I thank you so much for this valuable post.