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How do you validate pre-requisite programs?

Started by , May 24 2013 08:54 PM
9 Replies

Hello All,

 

How do i validate prerequisite programs.  Is a record review required.

 

Thank you in advance

 

Marvis

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SQF 2.5.1.1 - How do I validate waste management for Corrective action? Validate setting machine parameters for the old production Prerequisite Programs and Documentation Where can I go to validate a manufacturer is IFS or FSSC22000 certified? How can one validate claims made on a product?
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Hello Marvis,

   What certification are you trying to pursue?

 

Moreover, please read the following thread:

http://www.ifsqn.com...equisite-plans/

 

It pertains to SQF.

2 Thanks

Hello Marvis,

   What certification are you trying to pursue?

 

Moreover, please read the following thread:

http://www.ifsqn.com...equisite-plans/

 

It pertains to SQF.

SQF Certificaiton level 2.

SQF Certificaiton level 2.

Nice, good luck! feel free to ask any further question you may have.

SQF Certificaiton level 2.

Dear MBrown,

 

Hopefully you have now perused the link supplied by sci ?

 

One particular problem as mentioned in that thread is that the guidance SQF validation requirements seem to have confused auditors as well as auditees. Some other threads here also illustrate the confusion, and (variable) solutions.

 

One could previously put some of the blame on Codex semantics in their 2003 epic but their current 2008 “update” (seemingly ignored by SQF ?) is IMO a lot clearer. (In comparison, I think you will find the excellent NACMCF presentation is very operationally understandable in their old, but still “current”, primary document (ca 1997-8).

 

Perhaps this is a good opportunity to let your dedicated magician aka  “Practitioner” justify his/her existence and stipend. Or perhaps you are the Practitioner ? :biggrin:

 

Rgds / Charles.C

addition to previous post -  

 

here is a 2013 example of  validation-related / SQF auditor woes and, apparently, their pragmatic (ie partially inexplicable) solution -

http://www.ifsqn.com...ge-2#entry60756

(particularly see the above post and following ones)

 

One can see some (vague) similarities in the above "solution" to the in-use Excel SQF Validation-Verification matrix example given by mgourley in this 2012 post (now dwld 450 times !) –

http://www.ifsqn.com...ams/#entry56545

 

Seems to me that 2nd link is an example of  “If you can’t beat them (or even understand them) … them.

 

Rgds / Charles.C

I have a risk assessment that documents a breakdown of the pre-requisites and lists what the risk pontentially are via likliehood & severity (exactly the same as i do for assessing CCP's in my HACCP)

i then have translated the information into a table that demonstrates how we control the risks.

 

For instance, staples

 

We say that its a physical risk, likelihood is 1, severity could be 3. The risk is doubtful because we don't allow staples in production. Our control is that no paperwork is issued to production with staples.

 

Our pre-requisite program is also audited annually

 

Caz x

1 Like1 Thank

I have a risk assessment that documents a breakdown of the pre-requisites and lists what the risk pontentially are via likliehood & severity (exactly the same as i do for assessing CCP's in my HACCP)

i then have translated the information into a table that demonstrates how we control the risks.

 

For instance, staples

 

We say that its a physical risk, likelihood is 1, severity could be 3. The risk is doubtful because we don't allow staples in production. Our control is that no paperwork is issued to production with staples.

 

Our pre-requisite program is also audited annually

 

Caz x

 

Dear Caz,

 

Is this currently utilised for BRC6 or SQF (or both).?

 

I am guessing BRC 2.7.3. ? Seemed to me that their usage of "validated" can be equally interpreted as verification, particularly as per BRC's invented glossary definitions for both terms. Maybe you simply like doing risk assessments :smile: .

 

Generally, i would hv thought that reference / conformance to an appropriately official  GMP treatise ought to constitute a validation. Period. But this tends to inconveniently limit the desired scope, eg allergen management perhaps. 

 

So surely it should be acceptable to select an "approved" comprehensive (?) set of Prerequisites like PAS 220 and use this to justify (via Verification) that the (controlled) result is a low risk activity.

 

Oh dear, i have just clapped FSSC22000 :crying:

 

Rgds / Charles.C

Hi Marvis,

 

By simply checking what you have established PRP's is already validation but how you will document it? Let me share you sample of documented consolidated PRP's format which we are using as some of the objective evidence on how we document our validation.
In the sample format you will simple document the type of PRP's implemented, possible hazards or sources taht can control by your PRP's, then you will input your control measure, of course the responsible person that will execute the control, the reference document you will use, your monitoring procedure and the verification part....hope it will help you....
 
Thanks and God Bless us,
Factory Hygienist

Dear Caz,

 

Is this currently utilised for BRC6 or SQF (or both).?

 

I am guessing BRC 2.7.3. ? Seemed to me that their usage of "validated" can be equally interpreted as verification, particularly as per BRC's invented glossary definitions for both terms. Maybe you simply like doing risk assessments :smile: .

 

Generally, i would hv thought that reference / conformance to an appropriately official  GMP treatise ought to constitute a validation. Period. But this tends to inconveniently limit the desired scope, eg allergen management perhaps. 

 

So surely it should be acceptable to select an "approved" comprehensive (?) set of Prerequisites like PAS 220 and use this to justify (via Verification) that the (controlled) result is a low risk activity.

 

Oh dear, i have just clapped FSSC22000 :crying:

 

Rgds / Charles.C

 

LOL Charles!

 

We are BRC 6 approved, but this doesn't stop me from "pinching" good bits from other standards in order to supplement what i do. I find it impresses auditors because they can see that your not bogged down with complying with one standard, but have used (the good things from) other standards as a continuous improvement tool, so i kill that bird too!

 

 

Too be fair, i bet there are a number of QA / Technical Managers out there who aren't aware of PAS220. I am, but only because i use the IFSQN so i get "exposed" to different standards. I always reference the standards that i have used in my top ter documents ( i make reference to certain clauses etc)

 

Caz x


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