26 replies to this topic

[SPL]

Can anybody provide recommendation for a US based FDA recognized LACF process authority?

 

Also what are the requirements to become one?

[RG3]

According to the USDA regulation 9 CFR 318.300, entitled "Definitions", a processing authority is "the person(s) or organization(s) having expert knowledge of thermal processing requirements for foods in hermetically sealed containers, having access to facilities for making such determinations, and designated by the establishment to perform certain functions as indicated in this subpart."

 

To qualify as a process authority, the individual or group must have the expert knowledge that comes from developing processes and evaluating process deviations on a regular basis.

 

In the FDA's Inspection Operation Manual, Inspectional Methods, a section addresses what information is to be requested about a firm's processing authority by the FDA investigators where FDA is not familiar with the particular process authority named by the processor.

[Sandima]

JBT Foodtech is an FDA and USDA recognized Process Authority.  See the information at the link below.  

 

http://www.jbtfoodte...ent/Sterilizers

[unzun]

Please refer to attached link which related with GMA's BPCS(Better Process Control Schol).

 

As I know, you're required to complete this course to become a LACF process authority.

There's a test at the end of that course.

 

http://www.gmaonline...oductNumber=P14

[unzun]

The link was wrongly attached, it's about the book not a training course.

Please refer to the the below link for the course.

 

http://www.gmaonline...BPCS-011411.pdf

 

 

 

Please refer to attached link which related with GMA's BPCS(Better Process Control Schol).

 

As I know, you're required to complete this course to become a LACF process authority.

There's a test at the end of that course.

 

http://www.gmaonline...oductNumber=P14

 

 

[Ratchet]

Completing a Better Process School does not a Process Authority make! I believe a key word in the regulations is "recognized". Generally no one can just call themselves a "Process Authority" unless they have they have the knowledge and equipment to establish a Thermal Process. Another specific and important requisite is to handle and correct, if possible, process deviations. My point, not just anyone can call themselves a PA. It would be dangerous and irresponsible. I believe JBT Foodtech is recognized by the FDA as a Process Authority. I performed this function in my organization(s) for 30 years as well as consulting in the field/

[Charles.C]

Completing a Better Process School does not a Process Authority make! I believe a key word in the regulations is "recognized". Generally no one can just call themselves a "Process Authority" unless they have they have the knowledge and equipment to establish a Thermal Process. Another specific and important requisite is to handle and correct, if possible, process deviations. My point, not just anyone can call themselves a PA. It would be dangerous and irresponsible. I believe JBT Foodtech is recognized by the FDA as a Process Authority. I performed this function in my organization(s) for 30 years as well as consulting in the field/

 

Dear ratcht,

 

Thks for the input.

 

So how does one achieve "recognized" ? Passing a FDA test ? Annually ?

 

Rgds / Charles.C

[Ratchet]

A "Process Authority" has always been kind of clubby. There is one group called the Institute For Thermal Processing Specialists or IFTPS that is a good source for PAs. There is no FDA test, it has no school, no diploma. Just experience until you are generally recognized as a Thermal Process Authority.  In LACF, it is also a matter of life and death (or bankruptcy) if a thermal process is calculated or applied incorrectly. I would not call myself a Process Authority unless I was sure of what I was doing and was recognized by my peers and all Regulatory bodies. The proper equipment is also needed.

[Chris @ Safefood 360°]

SPL, 

 

ratcht is on the money above. Some companies employ their own "process authority" while others contract that out. Ultimately it depends on the size of your organization and the number of products you will be processing to determine whether it would be advantageous to have an in-house authority or not. A proper Google search will help you find a list of competent Process Authorities from which to pick from. Here's a short list: http://extension.psu...-of-authorities

 

I've never met a Process Authority who was too intelligent for their own good, but I have seen a few that I wouldn't trust to heat up leftovers. Choose wisely.

 

-Chris  

[SPL]

Ratcht - Just by looking for one ,most PA's are just consultants.  Most of the PA's I seen have BS and years of experience.

 

Chris, Thanks for the list, PSU is my alma mater and contacted some of my professors. Most of the universities on that list won't provide letters but will only look at and evaluate formulas. Two of the commercial company's don't have PA's or provide PA services.

[SPL]

Ratcht - Just by looking for one ,most PA's are just consultants.  Most of the PA's I seen have BS and years of experience.

 

Chris, Thanks for the list, PSU is my alma mater and contacted some of my professors. Most of the universities on that list won't provide letters but will only look at and evaluate formulas. Two of the commercial company's don't have PA's or provide PA services.

[it_rains_inside]

Completing a Better Process School does not a Process Authority make! 

 

This is true - I am BPCS certified through Ohio State University and am not anywhere near the level of a PA. Our company houses our own PA, we also do a lot of co-packing, most of our co-pack customers have their own PA as well. 

[Charles.C]

Dear All,

 

Based on previous posts, the US bestowing protocol for "Process Authority" seems rather bizarre, or, more politely, unvalidated.

 

As i understand LACF processors must have the validation of their specific processes FDA approved. It seems very un-FDA-like for this organization  to accept names included on an "arbitrary' list as "Process Authorities" to solely act as such validations. 

 

I think there must be some kind of internal "rating" involved somewhere, even if apparently covert.

 

Rgds / Charles.C

[SPL]

Charles,

 

I was going to contact the FDA and ask them what are the requirements to be a recognized PA and if they had a list.

 

I think the one misconception that is rampant is the difference between better process control school certified and a PA. A BPCS certified  person must be employed by a company to review daily manufacturing documentation.  A company  must consult/ hire a PA to validate that their thermal processes are adequate and review any process deviations.  

 

But it must be nice to be a PA now, I haven't had a call returned in weeks. 

[bacon]

If your in the Pacific NW,

 

SPA (Seafood Products Association)

www.spa-food.org

 

Kenny Lum, Suba Gurram and the rest of the team are highly dedicated and committed to their members. I run into people former FDA Seattle District Director Charles Breen there at events (I believe 40 years with FDA).

 

Dont let the "Seafood" in their name throw you off: they the entire gambit of review, thermal heat distribution testing (process validation), etc. The cater to non-seafood canning as well and are very involved with current legislation and GFSI benchmark audit requirements. 

 

-Baron

Edited by baron, 31 October 2014 - 12:07 AM.

[Charles.C]

Charles,

 

I was going to contact the FDA and ask them what are the requirements to be a recognized PA and if they had a list.

 

 

Dear SPL,

 

If previous posts correctly depict the operational situation, will probably be a long wait.

 

Rgds / Charles.C

[Dharmadi Sadeli Putra]

Completing a Better Process School does not a Process Authority make!

Please read 21 CFR 108.35(g) related to BPCS.

PA is an institutional body like university, etc which capable enough (based on their skill & experience) to establish process schedule

Edited by avila muncar, 31 October 2014 - 03:32 AM.

[Ratchet]

 

Please read 21 CFR 108.35(g) related to BPCS.

PA is an institutional body like university, etc which capable enough (based on their skill & experience) to establish process schedule

Many LACF operations may have numerous BPCS on their staff, from retort operators to Shift Managers to CEO. It is a course designed to make one aware of the best operational procedures and the regulations for a LACF facility. I've seen entire shifts being taught BPSC on site by a competent group. Again, entirely different from a PA. Most of those that have BPSC certificates would not sign the bottom line on a Process Schedule. Stick to those individuals/Institutions that will do this for you and stand up to FDA scrutiny on Process records or deviations. Most retort manufacturers can do this or recommend a PA.

Edited by ratcht, 31 October 2014 - 12:21 PM.

[Charles.C]

Dear avila muncar,

 

Please read 21 CFR 108.35(g) related to BPCS.

 

The link seems to refer to the credentials of the equipment operator rather than the approval of the thermal process ? useful nonetheless and makes interesting reading. Thks.

 

This document  offers a (considerably) expanded interpretation of “Process Authority” although the ultimate impression is IMO not so different as previously suggested – an arbitrarily (self-?) designated status.

 

 What is a Process Authority (2).pdf   112.3KB   68 downloads

(1st upload had some format letters missing, sorry)

 

Rgds / Charles.C

 

PS - posted before seeing No.18

[jenjen3576]

Please refer to attached link which related with GMA's BPCS(Better Process Control Schol).

 

As I know, you're required to complete this course to become a LACF process authority.

There's a test at the end of that course.

 

http://www.gmaonline...oductNumber=P14

It is not necessary to complete the better process controls school to become a process authority. That really doesn't have anything to do with it. With years of experience in food (typically heat treatment, lethality and other points of interest for data) and usualy education, a process authority can become one for their own company or create their own company.   So essentially anyone can become one, however, there is a great deal of liability that goes with it.  You will be called on for deviations, to create the initial and ongoing "safe" process. You must understand microbiology and chemistry along with food science. I am currently training with our current process authority to become our PA because things would move along faster. 

[jenjen3576]

Charles,

 

I was going to contact the FDA and ask them what are the requirements to be a recognized PA and if they had a list.

 

I think the one misconception that is rampant is the difference between better process control school certified and a PA. A BPCS certified  person must be employed by a company to review daily manufacturing documentation.  A company  must consult/ hire a PA to validate that their thermal processes are adequate and review any process deviations.  

 

But it must be nice to be a PA now, I haven't had a call returned in weeks. 

 

There isn't a list from the FDA.  The BPCS is separate from the PA process.  The person doesn't have to be employed by the company.  we have a few and do retort and high acid/low acid canning.  It depends on what you are looking for but someone in your company could become the internal PA.  Hiring someone from the outside is possible too

[Scampi]

I would always contact a uni first. They have nothing to gain

 

Uni of Nebraska

NC state Uni

I know there's a few more, but that's all i can think of off the top of my head

[jenjen3576]

You can contact process authorities for LACF or Food process authorities in a google search. They will come up.  Universities are only select.  TechniCal is a great one for LACF especially for retort.

 

We have our own private one that has his own consulting business.  His name is George Pilgrim out of New York.   

 

Ohio state university will also do PA work as they employ quite a few of them.

[jenjen3576]

Please refer to attached link which related with GMA's BPCS(Better Process Control Schol).

 

As I know, you're required to complete this course to become a LACF process authority.

There's a test at the end of that course.

 

http://www.gmaonline...oductNumber=P14

I also wanted to state that at the end of each chapter for BPCS there are tests.  as stated. you DO NOT have to take BPCS to become a PA.

[Scampi]

A process authority is generally a microbiologist with specialization in thermal processing who could care less about BPCS

 

That course is so someone in the facility where products are made understands what to do when the system isn't working and WHY it is so important to follow the schedule as written