14 replies to this topic

[idealdreams]

Hey guys! I'm slowly and painstakingly making my way through Module 2 of the SQF Code and I'm not quite sure how to proceed at this point. The guidance document for section 2.5.1 Responsibility, Frequency, and Methods states that a validation and verification procedure should be prepared for an audit but I'm not sure how to go about writing that procedure.

 

We are a small snack manufacturing company with two critical control points - metal detection & nut cooking temperature and both of these CCPs are heavily validated (metal detection functionality tests every two hours and thermometer readings of nut cooking temperatures every hour). All validation activities are documented and the documents are then submitted to me, the QA Manager. I verify that the temperatures met the critical limit and that no FAILED tests were run when testing the metal detector. In addition to CCP validation, myself or our QA technician will perform bi-monthly inspections of the plant and surrounding grounds to ensure compliance to all GMPs. There are several other validation and verification activities that take place on a frequent basis also.

 

Am I supposed to generate a procedure unique to each verification and validation activity or can I make a general procedure that umbrellas over all verification and validation activities?

 

Any help would be appreciated!

[ChocoTiger]

idealdreams,

 

Here are generic examples of what is needed for 2.5.1.1-2.5.1.3, 2.5.2.1-2.5.2.2, 2.5.3.1, and 2.5.4.1-2.5.4.2.  The programs I included in this are the prerequisite programs required by SQF.

 

Let me know if you need any additional help.

 

ChocoTiger

Attached Files

•  Example 2.5.2.1 Validation and Effectiveness.docx   20.73KB   692 downloads
•  Example 2.5.4.1 Verification of Monitoring Activities.docx   20.79KB   599 downloads
•  Example 2.5.4.2 SQF System Verification Form.docx   21.94KB   575 downloads
•  2.5.1.2, 2.5.2.1, 2.5.3.1, 2.5.4.1 Verification And Validation Worksheet.xls   67KB   683 downloads

[Charles.C]

Hi ChocoTiger,

 

Thks for yr collection of files.

 

As long as the SQF auditors are happy with yr excel format all is 100% good  but it was my understanding that "Validation" of PRPs is no longer required for SQF Standard. ? (seemingly replaced by "effectiveness")

 

Perhaps the auditors are simply unable to break with tradition.

 

TBH i would have expected to see some comment matching 2.5.2.1(i) in the table but "if it works ........"

[ChocoTiger]

CharlesC,

 

As a certified SQF Practitioner, participant in 2 successful SQF Audits, and the author and custodian of the SQF System at my current establishment, I KNOW FOR A FACT, that this example of Verification and Validation is acceptable to SQF Auditors, as I used it in my SQF Certification Audit in February.  In addition, I got the original Excel file from a post on this very website last fall.  The SQF Code has not changed in the past year, during which I had the 2 audits, so any "changes" are not per SQFi itself.

[Charles.C]

Hi ChocoTiger,

 

From the SQF website  -.

 

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.

 

 

The above (undated) quote was, afaik, first noted on the forum in December 2014

 

The text in the Code changed with the appearance of the 7th Ed. in 2012 but i am not aware of when the SQF auditors actually implemented it.

[ChocoTiger]

That stated clarification is all well and good, however the "Confirmed to ensure they achieved the required result" still means the auditor is going to be checking to see if an establishment is doing what they say they're doing....tomato, tomatoe.....Real world experience vs. reading the SQFi website.  Being over prepared and ready for any possible question is a lot easier than having deal with Major or Minor nonconformances and have to to completely rewrite a program, or add large chunks that were missing in the original.

[Setanta]

My experience agrees with ChocoTiger's.  We've been SQF Level II since 2010.

[Charles.C]

Hi Chocotiger,

 

The change was originated in the CODE.

 

As i understand there was a good reason why SQF emphasised the change had been made on the website.

 

A discussion of the SQF's  interpretation of validation would be a much, much hotter tomatoe.

[Setanta]

Right.  It's theory vs. execution.  Going back to assist the OP, what will actually benefit someone striving for SQF certification? Probably something that works in real life. 

[idealdreams]

Thanks guys! Would the following be an adequate way to comply with §2.5.1?

 

2.5.1.1 The SQF practitioner is responsible for ensuring that all validation and verification activities are carried out. The practitioner may perform validation and verification activities themselves or assign the activities to a capable member of The Company’s staff.

 

2.5.1.2 The methods utilized by The Company to validate and verify critical limits, food safety fundamentals, pre-requisite programs, control measures, and all other aspects contained in The Company’s food safety plan have been documented through the use of standard operating procedures, forms, and policies outlined in The Company’s Quality Manual.

The frequencies of all validation and verification activities are documented in the areas mentioned above, in addition to master validation and verification schedule available in §2.5.3.

 

2.5.1.3 The Quality Assurance department shall receive and maintain records of all verification and validation activities.

[ChocoTiger]

Sounds good, idealdreams.

[CMHeywood]

Here's what our SQF auditor wanted to see:

 

Verification     Checking to see that control procedures and record keeping are maintained.  Who checks and how often do they check?

 

Validation       Upper management review to see if control procedures are effective (trends).  Who is on this committee, when do they meet and how do you keep minutes, record new action plans and their resolution.

[AKmuz]

I am bit confused regarding the monitoring checks. Are these checks taken from the hazard analysis for the QPP? 

[CMHeywood]

My company considers monitoring to be what the operators do:  checking temperatures, run speeds, in spec, etc.

 

Parameters that could affect food safety and/or quality need to be monitored and would be part of the control plan.

 

The control plan is based on the risk analysis which determines which controls should be implemented to mitigate the risk.

 

If the risk is not listed, then the control may not be adequately reviewed to verify that it is being done and to validate that is effective.

 

If the risk is listed but no controls are determined (listed in risk analysis), then likely there is no verification and/or validation.

 

The control plan should determine monitoring and verifying activities.  Validation reviews the effectiveness of the control plan.

 

Monitor - operator is checking for "within specification".

Verify - supervisor is checking that the monitoring is being done and corrections are being made for out of control or out of spec.

Validate - management is reviewing that the current controls are working.

[ltovar91]

idealdreams,

 

Here are generic examples of what is needed for 2.5.1.1-2.5.1.3, 2.5.2.1-2.5.2.2, 2.5.3.1, and 2.5.4.1-2.5.4.2.  The programs I included in this are the prerequisite programs required by SQF.

 

Let me know if you need any additional help.

 

ChocoTiger

 

 

Thanks for the example form very helpful. Is there any way where you can post an example on how to fill out the Verification form 2.5.4.2?

Edited by Charles.C, 06 December 2016 - 02:23 AM.
reformatted slightly