4 replies to this topic

[MWidra]

This is a very well written guide to validation of a HACCP program.  It was written for small meat and poultry establishments, but it could be applied to any system.  It explains what validation is, how to go about doing it, and what the difference is between validation, verification and reassessment.  It's a Handy-Dandy roadmap.

 

Martha

 

 HACCP_Systems_Validation.pdf   995.2KB   298 downloads

[Charles.C]

Hi Martha,

 

Many thanks for this.

 

The previous version (2013) was well-received and is posted at various places on this forum.

 

I do find it remarkable that, AFAI can see, no references to Codex’s classic 2008 document on Validation occur in the text.

 

Nonetheless, the system of  “initial validation”  looks in principle to be aligned to the Codex viewpoint regarding chronology.

 

The requirement for Validation of Prerequisite Programs is contrary to various  FS standards.  The divergence is due to the usual suspects, eg definitions/semantics/interpretation and the overlap with respect to “Verification”. Just another subjective haccp topic.

 

Overall, this document is surely a significant treatment on the theory/implementation of Va/Ve. The presentations relating to practical usage are impressive and  valuable.

 

The associated background text in the Federal Register  is also very interesting. I have attached here in case it subsequently becomes inaccessible.

 

 FSIS, background - haccp systems validation - 2009-0019-2015.pdf   202.64KB   144 downloads

[MWidra]

Hi Charles,

 

I can understand why there is no reference to the Codex and why there are some detail differences, because the US version of HACCP predates the Codex.  If you remember the history, HACCP originated as a military engineering quality system.  It was applied to food by Pillsbury in the late 1960s for NASA so the astronauts didn't get food borne diseases in space.  That could have been difficult at best and tragic at worst.  So there is a tradition/philosophy that the US government follows that has its own flavor, pun intended.

 

http://en.wikipedia....control_points 

 

Thank you for uploading the Federal Register page.  It makes it easier to find that way.  The Federal Register never goes away, but you sometimes have to know when something was published to find it quickly.

 

Martha

[Charles.C]

Hi Martha,

 

Yes, I agree with you that for food, both the USFDA and USDA/FSIS seem to have prioritised on the NACMCF version of HACCP. Not too surprising I guess.   The EC has similarly focused on Codex.

 

Historically, the relationship between the 2 standards seems to be rather subtle. It turns out that the Codex and NACMCF standards have been surprisingly closely interwoven for a considerable time, notably via (a) the Codex Hygiene Committee is apparently permanently chaired by US personnel, including (at least sometimes) FSIS executives and (b) the NACMCF standard was officially “harmonised”  in respect to Codex by the former's developer group in 1997 so that the two timelines nominally converged.

 

Nonetheless, even after the harmonization, it is obvious that significant differences still remained. For example NACMCF continued (I assume) its use of  CPs and the 2 standards had substantially differently worded definitions of Validation, ie –

 

Codex  – Obtaining evidence that the elements of the HACCP Plan are effective

 

NACMCF  - That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP Plan, when properly implemented, will effectively control the hazards.

 

 

IMO the NACMCF version was unquestionably superior in respect to clarity of chronology and content.

 

Subsequently, in respect to validation, it appears  that the NACMCF 1997 version has stayed  "as is”  whereas the Codex version has “sidled”  nearer to NACMCF, eg via their 2008 validation document. Currently Codex validation is defined as –

 

Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.

 

Obviously both USDA/FSIS and USFDA have further introduced their own “flavours” into the core NACMCF structure such as in the FSIS 2015 Validation scheme. The net  haccp result is a real jigsaw of  bits and pieces. A quite descriptive overview of the US scene (in 2014) is given in this document –

 

http://www.foodsafet...and-monitoring/

 

At the risk of overwhelming people, I noticed this IMO rather neat classification of  validation "types" which enables a superficial comparison between  Codex, NACMCF, FSIS –

 

Three commonly used strategies for process validation include concurrent, retrospective and prospective process validation.

Concurrent process validation is based on simultaneous collection and evaluation  of  data  from  a  process  concurrently  with  its  application.  This  is  used  when  there  is  a change  or  modification  to  an  established  and  previously  validated  process.

Retrospective  process validation is validation of product already in distribution based upon accumulated production,  testing and  control  data.  This  technique  is  often  used  in  analyzing  process  failures  that  result  in  product recalls.

Prospective process validation is a deliberate, forward-looking, planned approach that determines  if  the  process  can  be  relied  upon  with  a  high  degree  of  confidence  to  deliver  safe  food. Prospective validation is best suited for evaluating novel processes and must consider the equipment, the process and the product (Keener 2006)

 

.

Seemed to me that, initially, both Codex and NACMCF strive to be “Prospective”. FSIS appears to be  trying to add a little bit of “Concurrent” on top via Prerequisites.

 

I predict that FSIS users will shortly be asking (howling?) for a prescriptive set of requirements for typical Prerequisite Programs such as listed in iso22002-1.

 

PS - I noticed this (1998) snapshot containing  very brief summaries of the, then, recent haccp versions. Bit more flavour.

 

 the 90's haccps.png   260.72KB   1 downloads

[MWidra]

Interesting information, Charles.

 

I think that one of the differences between the FDA/USDA concepts and the Codex concepts concerning validation v verification comes from the US using a more broad way to validate anything.  When doing validation of measurement equipment for my last job, which was a contract research laboratory using GLP, our Q/C professional had me describe what the equipment was being used to accomplish, and what in the design of the equipment would allow that equipment to accomplish that function.  Very straightforward.  The verification of the equipment on an ongoing basis was showing that it did, in fact, when calibrated correctly, produce outputs that accurately measured the reality of what was it was asked to measure.  It was based on the broad concept of asking, "Can xxx do what we want it to do?  And what in the design of xxx makes it valid?" to validate, then asking, "Is it working correctly?" for verification.

 

The above quoted "3 types of validations" are only for processes and so are more narrow, but the broad way to validate can be applied to everything from a pocket ruler to making pudding.  And when applied to pudding, the "proof" or verification, is in the tasting, maybe.

 

The FDA is responsible for regulating much more than food, and their most strict regulations are applied to medical equipment and drugs.  So it is understandable that their concept of validation is more broad, and something that can be applied to some processes and equipment that are unrelated to food. 

 

Good discussion.

 

Martha