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Satisfying Desk Audit - 2.5.4.1 Verification of Monitoring Activity


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#1 khansen

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Posted 24 October 2012 - 06:58 PM

How are other people meeting this requirement for the desk audit?

For example are you writing in your prerequisite policy..the program is verified doing XXX activity or form etc. Or are you showing the auditor a separate policy listing each prerequisites with then stating each verification program for each prerequisite. Or are you just showing the auditor your SOP on how to do a given task. For example daily lab calibration activities.



#2 bacon

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Posted 25 October 2012 - 12:14 PM

Hello khansen,

I refer to "2.5.3 Verification Schedule" 2.5.3.1 "A verification schedule outlining the verification activities, their frequency of completion and the person responsible for each activity shall be prepared and implemented." and created a Validation - Verification Matrix for it (that contains all of the criteria for 2.5.4.1. and will also cover 2.5.1.2).

I give Codex Alimentarius definitions at the top for Val/Ver (so there is no argument) then row list all Pre-Reqs and CCPs.

Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.
Columns: What - Monitoring Form - Monitoring Method - Who - Frequency - Verification

Validation: Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.
Columns: Who - Frequency - Method - Criteria - Reference

It is allot of work but well worth it as it gives the you and the auditor a high level view.
Not sure if mine will work be we will see in January 2012 (when we go through a 2nd annual SQF audit).

Cheers,
-B


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#3 khansen

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Posted 25 October 2012 - 01:40 PM

Hello khansen,

I refer to "2.5.3 Verification Schedule" 2.5.3.1 "A verification schedule outlining the verification activities, their frequency of completion and the person responsible for each activity shall be prepared and implemented." and created a Validation - Verification Matrix for it (that contains all of the criteria for 2.5.4.1. and will also cover 2.5.1.2).

I give Codex Alimentarius definitions at the top for Val/Ver (so there is no argument) then row list all Pre-Reqs and CCPs.

Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.
Columns: What - Monitoring Form - Monitoring Method - Who - Frequency - Verification

Validation: Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.
Columns: Who - Frequency - Method - Criteria - Reference

It is allot of work but well worth it as it gives the you and the auditor a high level view.
Not sure if mine will work be we will see in January 2012 (when we go through a 2nd annual SQF audit).

Cheers,
-B



#4 khansen

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Posted 25 October 2012 - 01:41 PM

There doesn't seem to be an attachment that I can open...



#5 bacon

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Posted 25 October 2012 - 05:55 PM

There doesn't seem to be an attachment that I can open...


It is pretty much like the one mgourley posted to your inquiry today: http://www.ifsqn.com...isite-programs/

I just add a few more columns and Codex definitions.

Cheers,
-B
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#6 Charles.C

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Posted 26 October 2012 - 02:23 AM

It is pretty much like the one mgourley posted to your inquiry today: http://www.ifsqn.com...isite-programs/

I just add a few more columns and Codex definitions.

Cheers,
-B

Dear baron,

I well-know its an old chestnut but I would guess yr use of the typical Codex definition of validation to give a different validation “sub-heading” and subsequent input of “re-validation” data compared to that illustrated in mgourleys excel sheet (albeit some of the activities will probably be carried out within a typical QA program anyway). (see http://www.ifsqn.com...dpost__p__56545 )

I also noted yr elegant defensive preparation regarding yr quoted prioritisation of actual code contents vs guidance examples in case of a difference. (a unique codicil within GFSI approved standards ?). I lacked the persistence to re-examine the precise Va/Ve wording in the current version7 so I assume it is non-specific.

Maybe I missed the comment elsewhere but will yr forthcoming audit for SQF be yr very first one ? If so, then I anticipate some fireworks. However if yr validation interpretation has already smoothly passed auditorial scrutiny then you hv achieved a significant triumph IMO ( :thumbup: ). And such would appear to imply that different interpretations are in fact equally acceptable to SQF (assuming “they” appreciate the difference).

Rgds / Charles.C

Ps - @khansen, I deduce from the parallel thread quoted above that you can now open attachments OK. Good to know.

PPS - just noticed yr comment re 2nd annual audit. Assuming same setup was previously used then i think congratulations are in order although yr text appears somewhat ambiguous.

Kind Regards,

 

Charles.C


#7 bacon

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Posted 06 November 2012 - 08:16 PM

....I would guess yr use of the typical Codex definition of validation to give a different validation “sub-heading” and subsequent input of “re-validation” data compared to that illustrated in mgourleys excel sheet (albeit some of the activities will probably be carried out within a typical QA program anyway). (see http://www.ifsqn.com...dpost__p__56545 )

I think if one state ones definitions and used references from SQF literature, one will be fine with defending one's reasoning. I chose the Codex's definitions that SQF explicitly states as one of their foundations. One could use FDA's (as a competent authority) as well using this reasoning i think.

Maybe I missed the comment elsewhere but will yr forthcoming audit for SQF be yr very first one ? If so, then I anticipate some fireworks.

No, but it might as well be, as this facility's 1st audit (I was not working with them at the time) should have uncovered many, many gaps. I inherited much I did not expect from a very sloppy CB. So this is new ground; so we will see if the fireworks will be a the results of a celebration or friction.

Cheers,
-B

Edited by baron, 06 November 2012 - 08:18 PM.

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