9 replies to this topic

[skredsfan]

Hi everyone,

With the launching of our facilities prerequisites and HACCP plan in the very near future, Validation will be very important! I was curious to hear some of your thoughts as to good sources of validation for prerequisites & the HACCP plan. As most of you know cost always becomes a factor, so purchasing metal detectors and other expensive prevention equipment might not be in the cards. Are their any written scientific or regulatory sources that some of you prefer for various programs? By the way we produce paperboard packaging containers for food & beverage products.

[sadean]

Your sources of validation are going to depend on what you are trying to validate. If it is your HACCP plan and CCP's for pH, aw, temperature, etc., I recommend using


Microorganisms in Foods 6: Microbial Ecology of Food Commodities [Hardcover]
International Commission on Microbiological Specifications for Foods (ICMSF)(Author)




Microorganisms in Foods 5: Characteristics of Microbial Pathogens [Hardcover]
International Commission on Microbiological Specifications for Foods (ICMSF)(Author)


In order to validate metal detection, you can work with your sales person or maintenance company that you specifically deal with on the metal detector to help provide documentation for your validation.


Sanitation you would validate through microbiological testing.


There are so many areas to be validated so you may want to be more specific.

[HACCP Mentor]

The easiest source for PRP validation is legislation or regulatory standards.

Some other quick ideas for validation of PRPs can include (but not limited to):

• Cleaning – Ask your cleaning chemical supplier to providescientific data to support that their chemicals will prevent/reduce/eliminate pathogensor microbes.
• Metal Detector – Advice and report from the metal detector supplier/manufacturerthat the piece of machinery is going to perform a certain way ie detect type of metal, size of metal, suitability ofyour product at different temperatures.
• Allergen cross contact – levels of allowable allergens infinished products, VITAL
• Personal Hygiene – regulatory requirements around goodpersonal hygiene practices.
• Approved Suppliers – HACCP certificates issued by certified(eg. JAS-ANZ) certification providers. Lab results from suitably certified laboratories(eg. NATA) if are also certified toundertake the testing .

Validation can be either from:

(1) Reference documentation that indicates that the control measure of PRP element is going to be effective to control the identified hazard. This can include regulatory standards, guidelines, scientific literature, experimental studies, qualified experts.

(2) Process validation is generally for equipment or procedures that have been tested sufficiently to support that when followed - you can expect x result. This is where equipment manufacturers and processing experts can be of use.

Hope this helps

Cheers

Amanda

[Charles.C]

Dear skredsfan,

Have you decided on a particular standard to apply for certification to ? (apologies if already mentioned in other posts).

Reason for query is that as well-demonstrated in this forum, SQF is slightly peculiar in some respects regarding validation, ie has veered away from Codex to a certain degree. BRC is more or less direct Codex from memory.

Yr query is very wide scope.

IMEX the validation process is often a mix of historical, technical, and accessible knowledge, especially if one wishes to minimise self-experimentation.

The previous posts certainly offer a lot of help for food validation sources.

Unfortunately, I predict that a probable limitation for packaging is that model haccp plans and therefore related validation data is rather scarce. It's not my area so i might (hopefully) be wrong but i think one can count on two hands the number of useful websites for packaging haccp so far mentioned on this forum ?

On the other hand i appreciate there are a large variety of reference websites of quality / safety standards for routine packaging variables, eg inks, plastics, cardboard etc. These are theoretically drawn into the food sphere also but often concealed within the pragmatic "food grade" tag. Implementation of any specific references may well be location oriented and USA is probably richly endowed in your case.

For food haccp, I have personally only encountered a few books which IMO have well-stood the test of time, eg Mortimore and Wallace. For Packaging haccp i would be interested to hear of any ??

Rgds / Charles.C

[skredsfan]

Charles,

We're moving forward with FSSC 22000. Initially we had decided on SQF, but have since changed directions because we're already ISO 9001 Certified. With FSSC 22000 being an ISO based certification, it just made more sense. I'm getting close to implementing Prerequisites and our HACCP plan, which will be followed by pursuing the FSSC Certification (FSSC 22000 TRAINING IN SUNNY FLORIDA NEXT WEEK ). You're right about the number of packaging websites being scarce! I've used this one alot. http://www.iopp.org/...cfm?pageID=2264. It serves as a useful tool for setting up a food safety program for packaging, however it lacks information in the form of validation sources. As all of us would agree, we want to be prepared for auditors, so I want to have several sources that I can use to back up my programs. I've been looking into microbiological swabbing for equipment, etc. Maybe a VERIFICATION &VALIDATION FORUM would be beneficial on IFSQN?? A forum to share sources of verification & validation for various programs, certifications, etc. From a personal standpoint, I would love that! I greatly apperciate all of the information, documents, etc. that many of you share. This site has been my best source of information without a doubt.!

Dear skredsfan,

Have you decided on a particular standard to apply for certification to ? (apologies if already mentioned in other posts).

Reason for query is that as well-demonstrated in this forum, SQF is slightly peculiar in some respects regarding validation, ie has veered away from Codex to a certain degree. BRC is more or less direct Codex from memory.

Yr query is very wide scope.

IMEX the validation process is often a mix of historical, technical, and accessible knowledge, especially if one wishes to minimise self-experimentation.

The previous posts certainly offer a lot of help for food validation sources.

Unfortunately, I predict that a probable limitation for packaging is that model haccp plans and therefore related validation data is rather scarce. It's not my area so i might (hopefully) be wrong but i think one can count on two hands the number of useful websites for packaging haccp so far mentioned on this forum ?

On the other hand i appreciate there are a large variety of reference websites of quality / safety standards for routine packaging variables, eg inks, plastics, cardboard etc. These are theoretically drawn into the food sphere also but often concealed within the pragmatic "food grade" tag. Implementation of any specific references may well be location oriented and USA is probably richly endowed in your case.

For food haccp, I have personally only encountered a few books which IMO have well-stood the test of time, eg Mortimore and Wallace. For Packaging haccp i would be interested to hear of any ??

Rgds / Charles.C

[Charles.C]

Dear skredsfan,

Thks for reply.

IMHO you may have picked a tough one as far as the haccp part is concerned however I have no great knowledge of traditional packaging haccp so hopefully I am wrong.

Other than the present forum, the link in previous post is the only one I have recently seen although I think I recall at least one other site being linked here previously which has haccp samples also.

One comment; if not seen already, ISO22004 contains IMO a superb, detailed guidance on requirements for validation and verification, eg sections 8.1-8.4. Well worth studying for any haccp purposes. (You have not included “verification” in yr OP so I hv not specifically addressed it below. Tends to be less demanding than validation IMEX of traditional haccp.)

I don’t recall any detailed FSSC22000 haccp packaging plans on this forum other than in the commercial IFSQN package system.

No personal experience of FSSC22000 compatible packaging haccp plans however I have previously posted (with TonyC’s mentoring) a detailed model food haccp example here (yoghurt). A semi-detailed (ie flow chart + hazard analysis) plan for processed vegetables also exists. And a few examples of OPRP/CCP categorisation segments of various food haccp plans.

I anticipate you are going to have a lot of OPRPs to validate unless they are all included in PAS 223 (never really studied it). AFAIK no validation required for ISO22000 prerequisites, only verification.

Yr proposal about collecting validation/verification contributions into a separate forum has merit except that a very willing workhorse would be required for past material. (added/edited later)- I had a look in my archives and noticed I did try some sort of compilation some time ago via excel sheets but got rather overwhelmed due (a) potential scope (b) like haccp, so many diverse opinions / interpretations and © many posts are pre-linked to specific standards so that some duplication involved. I just tried searching forum for "validation" and got a list of "first 1000 hits!" Needs some thought, maybe initially target posts having actual food-packaging procedures / specific examples or references containing such.

It’s only a suggestion but for yr immediate purposes, maybe easier / more feedback if –
(a) try and define what are the specific items in yr FS which actually require to be validated.
(b) Plus a definition / implementation procedure for validation.
© Plus if there are appropriate data sources for (a).

Some typical equipment items such as metal detectors, allergen detection products are probably adequately (validation-wise) covered in existing threads here for other standards assuming some searching can be done. If otherwise, the previous posts in this thread look a good route for info.

I predict –
(a) will be largely defined by the haccp plan and will relate to control measures / critical limits / “ limits” for OPRPs and CCPs .
(b) will probably be based on the Codex version (2008). There are a variety of compatible formats exampled on this forum for food.
© will obviously depend on (a)

Perhaps you (or anyone) could suggest specific hazards which typically generate OPRPs / CCPs in typical paperboard packaging plans.
(A model plan with designated oprps / CCPs would be ideal but may well not exist.?)
Perhaps the FSAP site gives CCPs for an appropriate model plan? (not personally investigated).

Not wishing to hijack yr thread, just some ideas.

Rgds / Charles.C

[Foodworker]

With respect to your particular comment on metal detectors, I have only ever come across one packaging company that had one and that was only because they had a misguided ISO9000 consultant with no experience of packaging.

With paperboard cartons, there is a small chance of metal contamination from forme and other cutting blades, but the likelihood is tiny unless you have really poor practices like sharpening them in situ.

There are next to no really good information sources for packaging hazard analysis which give nice clear information about risk levels.

I am attaching the European Carton Manufacturers Code of Practice for GMP which you may find helpful.

In my opinion, the biggest risk with cartons comes from the potential for mixing different designs, so make sure you have good systems, in line bar code readers, line clearance protocols etc

Attached Files

•  Carton GMP (2).pdf   2.85MB   234 downloads

[skredsfan]

I completely agree with you regarding the use of metal detection equipment! I too believe it's very low risk. We have a strong system in place regarding first piece approval, bar code scanning, and line clearance. Thank You very much for the attached document!

With respect to your particular comment on metal detectors, I have only ever come across one packaging company that had one and that was only because they had a misguided ISO9000 consultant with no experience of packaging.

With paperboard cartons, there is a small chance of metal contamination from forme and other cutting blades, but the likelihood is tiny unless you have really poor practices like sharpening them in situ.

There are next to no really good information sources for packaging hazard analysis which give nice clear information about risk levels.

I am attaching the European Carton Manufacturers Code of Practice for GMP which you may find helpful.

In my opinion, the biggest risk with cartons comes from the potential for mixing different designs, so make sure you have good systems, in line bar code readers, line clearance protocols etc

[Charles.C]

Dear skredsfan,

After quick look at FSAP site, I presume yr basic process is matched by at least one of their haccp analysed models. If so I guess this should represent a (literature) validation “of sorts” for the few CCPs mentioned. Nonetheless, a true hazard analysis, etc is specific to yr own setup / hazard analysis. Unfortunately FSSC22000 will require some further thought as to oprps unless there are (hopefully) none.

I noticed that the 2 FSAP, generic-type, haccp summary documents (attached below for convenience) both mentioned metal detectors however their inclusion may be for completeness rather than necessity. If no producers find it necessary to use them / no significant history of incidents then there is presumably a low risk as intimated by Foodworker. Must admit I didn’t realise hygiene in packaging plants was that good.

I have attached a few other documents, parts of which you may find interesting. cc6 was previously posted by Foodworker ( ) and is, I think, oriented towards BRC packaging.

 cc1 - micro.hazard in food packaging manufacturing.pdf   1.07MB   400 downloads
 cc2 - fsap FS Packaging Risks - Controls 2009.pdf   154.61KB   301 downloads
 cc3 -haccp aspects, fc packaging materials, EC, iso22000, 2010.pdf   199.12KB   309 downloads
 cc4 - fsap prerequisite programs.doc   328KB   266 downloads
 cc5 - model procedure-policy, cleaning Packaging machine & hopper.doc   69.5KB   265 downloads
 cc6 - Hazard Analysis Packaging Production.doc   85.5KB   322 downloads

Rgds / Charles.C

[skredsfan]

Charles,

Thanks so much! This is good stuff! I've seen cc4 before but never realized that links for supporting documentation were included! Terrible oversight on my part! As for metal detection, I think I should be able to use our Customer Complaint Notification Database as a source of justification for not having a metal detector. It's a very rare occurence to recieve complaints about metal in the paperboard, and they're usually paper mill related when they do occur. Thanks again for your help!

Dear skredsfan,

After quick look at FSAP site, I presume yr basic process is matched by at least one of their haccp analysed models. If so I guess this should represent a (literature) validation “of sorts” for the few CCPs mentioned. Nonetheless, a true hazard analysis, etc is specific to yr own setup / hazard analysis. Unfortunately FSSC22000 will require some further thought as to oprps unless there are (hopefully) none.

I noticed that the 2 FSAP, generic-type, haccp summary documents (attached below for convenience) both mentioned metal detectors however their inclusion may be for completeness rather than necessity. If no producers find it necessary to use them / no significant history of incidents then there is presumably a low risk as intimated by Foodworker. Must admit I didn’t realise hygiene in packaging plants was that good.

I have attached a few other documents, parts of which you may find interesting. cc6 was previously posted by Foodworker ( ) and is, I think, oriented towards BRC packaging.

 cc1 - micro.hazard in food packaging manufacturing.pdf   1.07MB   400 downloads
 cc2 - fsap FS Packaging Risks - Controls 2009.pdf   154.61KB   301 downloads
 cc3 -haccp aspects, fc packaging materials, EC, iso22000, 2010.pdf   199.12KB   309 downloads
 cc4 - fsap prerequisite programs.doc   328KB   266 downloads
 cc5 - model procedure-policy, cleaning Packaging machine & hopper.doc   69.5KB   265 downloads
 cc6 - Hazard Analysis Packaging Production.doc   85.5KB   322 downloads

Rgds / Charles.C