12 replies to this topic

[Ray Arcillas]

Hi everyone,

 

HI would like to ask if accumulated data on verification activities can eventually be considered as validation data?

 

Thank you very much!

 

Sincerely,

Ray

[Charles.C]

Hi everyone,

 

HI would like to ask if accumulated data on verification activities can eventually be considered as verification data?

 

Thank you very much!

 

Sincerely,

Ray

 

Hi Ray,

 

Can you be more specific as to the nature of the activities and the data ?

 

PS - Welcome to the Forum!

[Ray Arcillas]

Hi Charles,

 

Thank you for the warm welcome.

 

Before proceeding, i noticed a slight error in my question. It should be:

 

"HI would like to ask if accumulated data on verification activities can eventually be considered as validation data?" and not "HI would like to ask if accumulated data on verification activities can eventually be considered as verification data?"

 

You see i work in a water bottling company for almost 2 years now. Aside form my lab work, I am task to do the documentation etc.

 

With regards to your question which is in response to my question, here are some few examples:

 

1. Product with foreign objects. We have many years of data on product complaint with foreign objects. So can I make a narrative on these data to support/validate that the final product inspection process should be a CCP?

 

2. We sanitize our filling machines with either a hot water (thru CIP) or a sanitizer. However, we do not do swabs nor check the rinse water for micro. But we do check for microbiological parameters with the first bottle/s out which is basically our product already. Records show that we did not have any problems yet with micro as far as filling machine sanitation is concerned. So can I make a narrative and accumulate all the micro test data on the first bottles to support/validate that the CIP/sanitation process are effective?

 

Thank you very much in advance.

 

Best regards,

Ray

 

 

 

.   

[Simon]

I fixed your question in your original post Ray.

 

Regards,

Simon

[Dr Vu]

as far as i remember tthere is several  steps acceptable as part of validation

• Third Party Scientifically based study
• Mathematical Modelling
• use of statistics
• Admissible industrial practices / best practices
•  Collection of Data in normal production
• Simulated Production / design of experiment
• Historical Knowledge

what you are doing i would call it a "methodologically oxymoron"   The method you described seems to be   collection of data  in normal production   which is allowable as a Validation method , HOWEVER   ,if something is wrong you already have product made which costs $$  and  testing product is not really an admissible industrial practice 

 

 i hope this makes sense...

[Charles.C]

Hi Ray,

 

A few comments –

 

No.1

Product with foreign objects. We have many years of data on product complaint with foreign objects. So can I make a narrative on these data to support/validate that the final product inspection process should be a CCP?

(a) The answer depends on yr process details and the risk assessment. For example, very few complaints would presumably support no CCP ?

 

 

No.2

We sanitize our filling machines with either a hot water (thru CIP) or a sanitizer. However, we do not do swabs nor check the rinse water for micro. But we do check for microbiological parameters with the first bottle/s out which is basically our product already. Records show that we did not have any problems yet with micro as far as filling machine sanitation is concerned. So can I make a narrative and accumulate all the micro test data on the first bottles to support/validate that the CIP/sanitation process are effective?

 

 

(a) Personally I would have thought that validation of the filling machine cleaning/sanitizing  would require directly related f.m. data such as that which you initially mention.

 

eg -

http://www.fda.gov/I...s/ucm074922.htm

[Ray Arcillas]

@ Mr. Simon:

 

Thank you very much for fixing my question.

 

@ Dr. Vu and Mr. Charles C:

 

Thank you for the answers.

 

For my No. 1 example, I suppose that i can use the accumulated data to support that the final product inspection should be a CCP as there have been many incidents of products with foreign objects before though this occurrence had tremendously decreased now.

 

For my No. 2 example, I think that I will use that data in the mean time. Right now, there are only two of us in the lab working in shifts and both of us has to do the micro and chemical analysis and other tasks in our respective shifts. On my case, there is also documentation and supervision. When the new microbiologist will arrive, I think that we should do the swabs. I got what you mean Dr. Vu that what we are doing now is not in a way preventive. But sometimes you have no choice when all "they" want is "to produce".

 

The FDA link is very good Mr. Charles C.. 

 

Muchisimas gracias!. 

.  

[Charles.C]

Hi Ray,

 

Regarding No.1, I don't know yr process but you can have a look at the haccp plan in this post which may be similar  -

 

http://www.ifsqn.com...ram/#entry47723

[CMHeywood]

I work for a company that makes plastic, flexible packaging for food contact.  We are SQ Level 3 certified.

 

To use consistent language, we use the following:

 

MONITORING - someone is checking or testing and writing down the results on an "official" log sheet.  Signature or initials promote accountability to SOP's.

 

VERIFYING - a manager or supervisor is auditing the log sheets to make sure they are being completed and all is within spec.  Signature or initials indicate adequate review of daily logs.

 

VALIDATING - looking at trends over time to confirm (validate) that control measures are appropriate and correct.  Review may also be done in conjunction with customer complaints, rejections, etc.  This would be management review at the senior level.  Recorded minutes of the review meeting indicate that senior management is committed to food safety and continuous improvement.

 

Simply collecting documents doesn't verify or validate anything unless there is some type of audit and/or review.

[Ray Arcillas]

Thank you Mr. Charles C. 

 

I saw a HACCP hazard analysis for bottled water production on the link that you gave and downloaded it for reference. We have many common operations in reference to that analysis. But i believe that they don't use returned Polycarbonate (PC) bottles. We use returnable bottles, and hence my example No. 1 about finished product inspection.

 

Cheers,

Ray

[Ray Arcillas]

Hi Mr.Heywood,

 

Greetings!

 

Thank for the definition of terms. 

 

I think that Validation is not only limited to confirming if control measures are correct and appropriate. I believe that it covers PRPs (it's effectiveness) and CCPs (to show proof that a particular step needs to be a CCP). I hope that I am right though. 

 

Yes, the data that I have collected will be grouped an analyzed, that is why I will make a narrative of it for my superiors to read and approve. 

 

Cheers,

Ray

[Charles.C]

Hi Mr.Heywood,

 

Greetings!

 

Thank for the definition of terms. 

 

I think that Validation is not only limited to confirming if control measures are correct and appropriate. I believe that it covers PRPs (it's effectiveness) and CCPs (to show proof that a particular step needs to be a CCP). I hope that I am right though.

 

Cheers,

Ray

 

Hi Ray,

 

Regarding yr usage of returnable bottles it has been my experience that these are indeed subsequently often unacceptably cleaned/sanitized. Nonetheless, IMEX,  haccp plans' handling of  inputs to a process although at one time did often include CCPs (sometimes many)  rarely does so in modern haccp usage. The choice of CCP/PRP  may also relate to yr intending certified FS standard, if any.

 

Regarding scope of haccp validation, not sure if you are using any particular FS Standard or haccp methodology. You are indubitably correct for CCPs but, on average, maybe the opposite for PRPs.

 

afaik, there are two primary "reference" definitions of validation for food haccp. It is probably preferable to select one of them, eg Codex, if the choice is up to you.

 

Of course you may be certifying to a locally defined haccp system which controls yr options.

 

@CMHeywood - Yr interpretation of validation is maybe correlated to  SQF's individualistic  viewpoint of Codex ?

[Ray Arcillas]

Hi Mr. Charles C,

 

I read from the Canadian Bottled Water Association that the International Bottled Water Association (IBWA) is still deliberating about verification process of the inspection of refilled returnable bottles as CCP. The statement is not verbatim though. I tried to locate the document where i read it, but cant seem to find it.

 

Thanks for your many inputs..

 

Ray