Need help developing a validation record

Hi everyone,

I think I have to make a Validation record. Can you give me more information on how to make it and when to use it?

Validation means provide evidence to demonstrate the effectiveness of a system of controls.

You will need to look at your process and then work out for what controls you need validation e.g. for cooling, freezing etc. You need to give more information before any memebers can assit you.

Regards

Ajay

On another thread Tony kindly posted a sample validation record

In case you need a little nudge - verification (in general terms) asks - "Are we doing what we said we would do? " Validation asks- "Is it working?"
So for your critical control points and each pre-requsiite program you should ask- how do we know and demonstrate that this is working? The best answers are summaries of data from the program.

I agree with the comments posted by Cathy.


Ajay Shah

Dear Cathy,

Validation asks- "Is it working?"

Maybe this is an American definition.?

It seems rather at variance to the Codex version to me in respect to the chronological aspect.

Rgds / Charles.C

Please elaborate Charles - thanks

Please elaborate Charles - thanks

Dear Cathy,

In general I prefer minimalist definitions like yr suggestion but in this case I feel a little caution is necessary.

It's only my interpretation but, to me, yr "definition" implies an activity which is primarily post implementation of the relevant control measure. Codex adopts an opposite view (eg see the attach. in post #9 of thread below).

I think yr suggestion is sort of SQF "style".

IMO, the SQF standard (internally) messed this topic up quite well. For example this thread has some details -

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

The reality is that there exists a whole range of "validations" depending on the particular business (including from memory both Pre- and Post- formulations). In the food scene, I suspect that the Americans (politely) prefer home-grown definitions (and apparently Australian also ) where possible rather than Codex. This is perfectly OK of course but the net result is that in various places an apples vs oranges discussion ensues.

Rgds / Charles.C

Thanks Charles - that helped a lot and I see your point. Validation includes activities or information collected prior to implementation. Validation documents include those that show the science behind the decisions that led to control limit and other design decisions. This is proof that the system should work and is designed properly. The data that flows once the process begins is further validation. Sometimes for training I do simplify. In the future I will include in my informal definition both - will it work and is it working? It is best to keep on the same page no matter where we live since the food market is global.

Hi shabani,

What is the Verification Record for?

Once you have developed your validations and verifications, you will also need to develop A Verification Schedule.

Cathy & Charles C: my input on the Validation & Verification debate.

Methods for Validation of Critical Limits

• Validation = Current (proof what you are doing is effective)

• Temperature checks of product, processes or equipment
• Microbiological tests
• Visual checks of personnel, processes, and finished product

Methods for Verification of Legal, Food Safety & Quality Controls

• Verification = Past (proof you are doing what you say you are doing)

• Review of reports, analysis, records, and audits

Hi everyone,

I think I have to make a Validation record. Can you give me more information on how to make it and when to use it?

At first, I really liked your perspective, but then wondered - what micro test is not a review of the past?

Dear Jakmqa,

I suspect Cathy's comment was referring to the Codex "chronological" principle as per post#8, an aspect which your earlier post left unanswered (or at least i think it did ?).

Rgds / Charles.C

Oopsies.

And yeah, you're correct. I did leave that unanswered.

Well then:

Methods for Validation of Critical Limits

• Validation = Current (proof what you are doing is effective)

• Temperature checks of product, processes or equipment
• Microbiological tests
• Visual checks of personnel, processes, and finished product
• Codex: 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.

Methods for Verification of Legal, Food Safety & Quality Controls

• Verification = Past (proof you are doing what you say you are doing)

• Review of reports, analysis, records, and audits
• Codex: 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.

Hmmm, Charles. I still think SQF has stood by Codex's meaning of the two words. The SQF likes to dribble on and on (a bit like me, really).

And personally, I follow:

• Codex Alimentarius (Global)
  
• FSANZ, Woolworths (Australian)
  
• SQF (was Australian! Now belongs to USA)
  

Dear Jakmqa,

I suspect Cathy's comment was referring to the Codex "chronological" principle as per post#8, an aspect which your earlier post left unanswered (or at least i think it did ?).

Rgds / Charles.C