3 replies to this topic

[Costello]

I understand they want programs validated, and I have created a form for validation. But the auditor said this needs to be completed for each element of Module 11? This is a little confusing to me, on which topics need to be covered? 

 

 

 

2.5.1.1 The methods, responsibility and criteria for ensuring the effectiveness of all applicable elements of the SQF

Program shall be documented and implemented. The methods applied shall ensure that:

i. Good Manufacturing Practices are confirmed to ensure they achieve the required result;

ii. Critical food safety limits are validated, and re-validated annually;

iii. Changes to the processes or procedures are assessed to ensure controls are still effective; and

iv. All applicable elements of the SQF Program are implemented and effective.

[Scampi]

You're auditor is mistaken-plain and simple

 

Your CCP (if any) MUST be reviewed yearly (if nothing has changed since last review)

 

BUT SQF also requires an internal audit, but what's required for that is pretty clear

 

 

measuring the effectiveness of something like, GMP training is NOT even close to VALIDATING a CCP

 

me thinks your auditor doesn't understand the difference between VALIDATION and VERIFICATION

 

Validation – is what we do, going to work. Is it going to achieve the outcome that we desire and require? An example of this would be, we say that we are going to cook a food to a particular temperature because we want to make sure that there is no harmful bacteria remain. To validate the temperature chosen, we could refer to legislation, scientific journals or other data that supports the cooking temperature we have selected will kill the harmful bacteria.

Verification is best defined as being the things we do to see if we are actually doing what we say we are going to do. So in the above example, with the temperature to kill the harmful bacteria, we would check or verify that the food was actually reaching that temperature. This would be done through testing the temperature of the food.

[Costello]

EXACTLY what I am thinking! This is the frustrating part because you go changing and adding things that an auditor says or wants, then the next year it is dinged wrong. The code can be pretty confusing at times.  Thank you for your insight, it's the same as mine. I am just going to roll with it. 

[kingstudruler1]

I think I might not agree.   

I believe it is intended for all of section 11 as GMP= section 11 is sqf language.   Specifing each clause is a stretch tho.  

 

There should 4 parts to everything we do.  

 

say what you do = Procedures/policies - SQF = methods

Do what you say = actions and records

Verify = prove that you are doing what you say

Validation = prove that what you are doing is effective at achieving the intended result

 

if your trainig program is not effective it should be improved. if you maintenance program is not effective,  it should be improved.  if you food defense plan is not effective it should be improved.  if your sanitation is not effective it should be improved.  ETC   How you go about evaluating these as effective requires a little thought and effort and might be a little more subjective than a CCP.     We should be evaluating effectiveness none the less. 

 

I think SQF  did a better job of this in the 8.1 and guidance.       

Edited by kingstudruler1, 14 December 2021 - 10:44 PM.