20 replies to this topic

[khansen]

I am struggling with Validation like many others. The auditor and I don't seem to agree on the way I wrote my prerequisites. She stated that they don't have a method for validation listed. I am looking to see if anyone would post their validation schedule for their prerequisite programs I think that would help me or an example one of their prerequisites. I can't seem to post an example of one of my prerequisites. I have 13 prerequisite programs.

Waste Management
Training
Allergen control
personnel practices
cleaning and sanitizing
maintenance control
pest control
storage and transportation
physical control of contaminants
water quality
program supplier approval
building and grounds
calibration

[Charles.C]

Dear khansen,

Not a user of SQF myself but I daresay the requirements of ver7 are analogous to previous (if otherwise pls inform) ?. As you are probably aware, in previous ver., SQF has a somewhat atypical interpretation of Va/Ve.

There are several threads (mostly pre-ver7 I think), some with examples, regarding this topic on the forum, eg -

http://www.ifsqn.com...dpost__p__42912

http://www.ifsqn.com...dpost__p__46741

http://www.ifsqn.com...dpost__p__51090

I note that you hv already visited above threads ( ) so perhaps you need to be a little more detailed on your specific requirements / auditor criticism.
Perhaps try posting an example of yr current procedure again ? (what type of file?, normally no major problems but occasionally temporary hiccups do occur )

Rgds / Charles.C

[khansen]

I like a physical examples. When I try to post it states the file is bigger then 1k...just a typical word document...

[mgourley]

I am struggling with Validation like many others. The auditor and I don't seem to agree on the way I wrote my prerequisites. She stated that they don't have a method for validation listed. I am looking to see if anyone would post their validation schedule for their prerequisite programs I think that would help me or an example one of their prerequisites. I can't seem to post an example of one of my prerequisites. I have 13 prerequisite programs.

Waste Management
Training
Allergen control
personnel practices
cleaning and sanitizing
maintenance control
pest control
storage and transportation
physical control of contaminants
water quality
program supplier approval
building and grounds
calibration

Something like this?

Attached Files

•  Verification And Validation Worksheet.xls   39.5KB   3382 downloads

[khansen]

That is a very nice matrix. Thank you for sharing. Is this what other people are using to pass the requirement for the desk audit? Are most people using a chart or do they have the same info written into their prerequisite programs? Or are they doing both?

[MFSC]

I use a chart for review and it provides the auditor with a good reference. But I also have it in my PRPs

[mgourley]

I have a Management Review paragraph and a Validation paragraph in all my PRP's in addition to the matrix I provided.
That may or may not be a good idea. If you change one or the other, you need to change both. It would probably be best to reference the matrix in the PRP, rather than to spell that info out in the PRP.

Marshall

[RCF]

Agree, this is an excellent matrix, really adds value.

Thank You for sharing.

[Philips]

This is nice. Who ever posted it, a great and thumbs up?cheers

[Tony-C]

I am struggling with Validation like many others. The auditor and I don't seem to agree on the way I wrote my prerequisites. She stated that they don't have a method for validation listed. I am looking to see if anyone would post their validation schedule for their prerequisite programs I think that would help me or an example one of their prerequisites. I can't seem to post an example of one of my prerequisites. I have 13 prerequisite programs.

Waste Management
Training
Allergen control
personnel practices
cleaning and sanitizing
maintenance control
pest control
storage and transportation
physical control of contaminants
water quality
program supplier approval
building and grounds
calibration

Here are relevant posts made previously on the forums:

http://www.ifsqn.com...dpost__p__43089

http://www.ifsqn.com...dpost__p__46784

I quite like the schedule posted by Marshall but would add Product Conformity/Non Conformity as Validation where history of Complaints is used as evidence.

Kind regards,

Tony

[Larrauri50]

Why not consider the Codex Alimentarius, to validate and HACCP prerequisites?
For reference there is CAC / GL 68-2008 Guidelines for the validation of control measures for food safety.

[mgourley]

Why not consider the Codex Alimentarius, to validate and HACCP prerequisites?
For reference there is CAC / GL 68-2008 Guidelines for the validation of control measures for food safety.

Valid point, however the OP was asking about SQF. And as many threads here discuss, SQF and Codex are not necessarily in agreement as to the definitions of Verification and Validation. The OP also asked for an example of a schedule, which the document you cite does not provide.

It would be nice if all the various GSFI schemes would just agree on something as basic as validation and verification.

Marshall

[mgourley]

Valid point, however the OP was asking about SQF. And as many threads here discuss, SQF and Codex are not necessarily in agreement as to the definitions of Verification and Validation. The OP also asked for an example of a schedule, which the document you cite does not provide.

It would be nice if all the various GFSI schemes would just agree on something as basic as validation and verification.

Marshall

[Cravin' Cajun?]

Great resource...really appreciate it!

[bacon]

Per page 35 of the SQF Code edition 7:

"
b) References
The SQF Code makes reference to the current edition of the CODEX Alimentarius Commission Guidelines for the
Application of the Hazard Analysis and Critical Control Point (HACCP) System and the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF) Hazard Analysis and Critical Control Point Principles and Application
Guidelines, adopted August 14, 1997. "

I use CODEX Alimentarius Commission Guidelines for my definitions and state them explicitly. If one has a disagreement about SQF definitions of verification/validation: ones defense can be pointing to page 35 of the SQF Code edition 7.

[Charles.C]

Per page 35 of the SQF Code edition 7:

"
b) References
The SQF Code makes reference to the current edition of the CODEX Alimentarius Commission Guidelines for the
Application of the Hazard Analysis and Critical Control Point (HACCP) System and the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF) Hazard Analysis and Critical Control Point Principles and Application
Guidelines, adopted August 14, 1997. "

I use CODEX Alimentarius Commission Guidelines for my definitions and state them explicitly. If one has a disagreement about SQF definitions of verification/validation: ones defense can be pointing to page 35 of the SQF Code edition 7.

Dear baron,

I personally hope your (SQF) interpretations are correct but I fear you may have oversimplified a little. The page you refer also contains this paragraph directly following the one you mention.
 

 

© Definitions
For the purpose of this Code the definitions outlined in Appendix 2: Glossary of Terms apply.

Paragraph © leads to >>>

 

Validation As defined in the NACMCF Hazard Analysis and Critical Control Point Principles and Application Guidelines, Adopted August 14, 1997 as amended from time to time and the Food and Agriculture CODEX Alimentarius Commission Hazard Analysis and Critical Control Point (HACCP) – Guidelines for Implementation and Use, ALINORM 97/13A as amended from time to time. Essentially validation as applied to control limits seeks to prove that the intended result was achieved and that it actually worked.

Verification As defined in the NACMCF Hazard Analysis and Critical Control Point Principles and Application Guidelines, Adopted August 14, 1997 as amended from time to time and the Food and Agriculture CODEX Alimentarius Commission Hazard Analysis and Critical Control Point (HACCP) – Guidelines for Implementation and Use, ALINORM 97/13A as amended from time to time. Essentially verification as applied to control measures seeks to prove that the control measure was done according to its design.

(pg 153)

The last sentence of ”validation” appears to define the current SQF interpretation. (seems same as previous 2000 version, see below)
SQF’s interpretation does not appear to me to “align” with, AFAIK, the current Codex view of validation (  Codex validation, verification 2008.pdf   206.71KB   249 downloads ) -

 

Validation (2008): Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome

.
Not sure if this later document is considered a de facto amendment to the 2003 (SQF referenced) Codex hygiene document (prob.last official version). Regardless, the later version is IMO conceptually unchanged but a more explanative version of the 2003 one -

 

Validation (2003): Obtaining evidence that the elements of the HACCP plan are effective.

With respect to SQF's def. of “verification” the English phrasing is so odd that i find it difficult to interpret the intended meaning. Compare the Codex 2003 def. which still seems reasonably representative to many current texts, inc. the 2008 document above - "Verification: The application of methods, procedures, tests and other evaluations,in addition to monitoring to determine compliance with the HACCP plan"

I hope my validation criticisms may be demonstrated incorrect but it seems to me that the prev. reported distinctions between SQF and Codex have been firmly maintained.

(Notes)
Haven’t looked at the current “Guidelines” or the Standards own internal details to see if any relevant changes hv occurred as compared to previous SQF 2000? My guess is probably not ? Other users are welcome to comment if otherwise.
(added later -AFAIK the defs for Va/Ve were previously contained within the SQF Program-Vocabulary document, the wording in 2nd Ed 2009 looks identical to SQF ver7)(  SQF program Vocabulary 2nd ed.,2009.pdf   591.18KB   179 downloads )

Have not commented on NACMCF differences (if any) since nobody has brought this up. Maybe nobody is using it?. I think the 1997 document is so far without amendment?.
(added later - I enclose an extract from the NACMCF 1997 document below. It seems to me that, although considered a sub-unit of verification, validation is interpreted in a very similar way to current Codex documents while verification is equally close to the 2003 Codex def.)
 

 

Verification is defined as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.

One aspect of verification is evaluating whether the facility's HACCP system is functioning according to the HACCP plan. An effective HACCP system requires little end-product testing, since sufficient validated safeguards are built in early in the process. Therefore, rather than relying on end-product testing, firms should rely on frequent reviews of their HACCP plan, verification that the HACCP plan is being correctly followed, and review of CCP monitoring and corrective action records.

Another important aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled. Information needed to validate the HACCP plan often include (1) expert advice and scientific studies and (2) in-plant observations, measurements, and evaluations. For example, validation of the cooking process for beef patties should include the scientific justification of the heating times and temperatures needed to obtain an appropriate destruction of pathogenic microorganisms (i.e., enteric pathogens) and studies to confirm that the conditions of cooking will deliver the required time and temperature to each beef patty.

http://www.fda.gov/F...efault.htm#defs

Rgds / Charles.C

[JSwenPDX]

I have been citing the standards, be they test methods (e.g. calibration validation, CCP validation), regulations (e.g. site requirements and approvals), or industry standards (e.g. pest control) as my validation for the prerequisite programs and it has been sufficient in the past. I would call complaint trend review, calibration verifications, etc (ie internal monitoring activities) to be control measures that tell you whether you are out of control, which you would use during your annual verification review of your programs. I don't believe in using pest control records to validate a pest control program considering that a facility not monitoring flying insects wouldn't ever know if there was a problem based on their records.

 

Thoughts? Punch some holes in my approach to PRP validation.

[Charles.C]

Dear jswenpdx,

 

The sqf faq on website notes that prerequisite functions are not required to be validated.

Since when i have no idea. Eternity? <= 2 years

 

Rgds / Charles.C

 

PS - Below is quote ex-faq, the explanation sounds to me like some kind of zigzag to avoid discussing their anomalous use of Codex's validation

Why are PRPs not required to be validated? Instead, they are required to be verified as described in 2.5.2.4. Can you provide clarification as to whether PRP’s require formal validation?

The term “validation” specifically applies to control limits and requires scientific analysis to demonstrate that control limits are effective. Based on advice from our stakeholders, we reworded the requirement for pre-requisite programs to state that the PRPs be “confirmed to ensure they achieve the required result rather” than “validated.” The intent is to clarify the intent of the Code so that the effectiveness of the PRP is being met.

 

[JSwenPDX]

From the auditing guidance for 2.4.2, "may indicate compliance":

 

R

- records of PRP validations are available (http://www.sqfi.com/...uidance-7.2.pdf page 28)

 

So I suppose this is just a way that one can indicate their program is valid. It's included in several other pieces of evidence.

[Charles.C]

Do remember that the sqf guidance material comes with no guarantee of veracity. And has justified this tag on various occasions.

 

Not suggesting that sqf deliberately mislead, more likely they lack capable proof-readers or perhaps choose to ignore minor errors until they become major. Glossaries are a good source of strange definitions if you have a little spare browsing time, sqf definitely contains some of the weirdest but brc is not without blemish and as for the ifs text.......

 

On the pro-side, If called on, the sqf technical backup  can clearly produce excellent monographs, eg their allergen program document. it's a pity there are not more of the same. And they are free !

 

My guidance comment may also apply to the sqf faq but the latter has, afaik, not yet been specifically found wanting. The info. relating to compressed air is well in the running though.

 

iso-fssc22000 and also brc(from memory) do not require prerequisite validations so perhaps sqf have finally seen the light.

 

looking at Prerequisites, why validate a pre-defined, officially accepted, haccp support program ? But this conclusion assumes Codex validation, not the Sqf variety.

 

Rgds / Charles.C

 

PS - I couldn't quite work out from your post whether you were now agreeing that validations of prerequisites not mandatory, or the opposite ?

[markjoelangeles]

im no expert but this forum is helping me alot.. thanks!