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What exactly goes into Prerequisite Programs?

HACCP Pre-reqs

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#1 AGomez

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Posted 26 March 2015 - 12:43 PM

Hi Guys!

 

I am having a bit of trouble understanding exactly what goes into pre-req's. My facility has SOP's, policies, etc... but do I need to go into complete detail (Copy/Paste pretty much) when writting the pre-req's? Or is it just an overall summary of what our procedures cover? We are a co-packer of powder, granular, sugars, spices, and candies so our processes are pretty simple. Can someone provide an example? Thanks! I love this forum! As someone new to the industry who's learning as he goes, this forum is full of information!



#2 MWidra

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Posted 26 March 2015 - 03:16 PM

Hi AGomez and welcome!  Your program would contain your SOPs.  If your SOPs have everything that is needed to set up a policy and program, then you are good to go for that, and all you may need to add to the program are the forms to use for documentation.  Your program does not need to be another document separate from the SOPs, as long as one of your documents says what to do.  A program can be as simple as a single document or a complex as an entire binder of materials.

 

I was taught that your plans need to include the purpose, scope, responsibilities, procedures, list of the forms and documents to use, monitoring and review requirements, and document retention time.  That should satisfy an auditor.  Some may not need all that, but including them all covers all bases.

 

Others may have more insights as well.

 

Martha


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#3 xylough

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Posted 26 March 2015 - 03:54 PM

Hi,

 

Your question and the answers are not exactly black and white, clear-cut. Facilities currently under Mandatory HACCP with USDA or FDA and facilities  under voluntary HACCP organize their food safety programs differently and use various names for the different parts. It is a case of "a rose by any name would smell as sweet". People running food facilities use terms like Standard Operating Procedure (SOP), Pre-Requisite Program (PRP), Operational Pre-Requisite Program (o-PRP), Policy. Program, Plan, GMP, Curent Good Manufacturing Practice (c-GMP) etc. in an inconsistent manner with each other. Some want to simplify and others want to have tedious complexity. Here is my take on it:

HACCP Plans are sometimes conceptualized as a pyramid with GMP as the fundamental foundation. GMP documents generally are a policy statement of what your facility's GMP are going to be.

The next layer of documents are the Pre-Requisite Plans or Programs. These sometimes include programs like Shipping and Receiving, Blood Borne Pathogen Control, Intrusive Maintenance, Preventative Maintenance, Hold and Release, Hold and Test, Glass on Premises. In concept, if these PRP are under control then the  frequency/severity of the risk/hazard is eliminated or significantly reduces to an acceptable level. PRP have varying elements but in general require certain features. Let me use Glass on Premises as an example.

 

Title: Glass, Brittle Plastic and Ceramic Program

Purpose: Why you find it needful to establish this particular program, e.g., To establish the Written program plans, policies, procedures and supporting documentation for the control of glass.....quarterly list(register)  of known glass, storage, handling, training, disposal, acceptable and unacceptable types of plastic, plan for elimination of know glass

Scope: what facility(ies) this program applies to, e.g., ACME Food Company

Responsibility: what department, position titles and or individuals will be held responsible to follow, perform, monitor, document, verify, validate this program

Procedures: here is where your SOP enters the stage. Not all PRP programs require a procedure(s), but most do. In this case you need to write an exacting, detailed, step-by-step SOP for how glass will be stored, handled, registered, audited, cleaned up when it breaks.

Generally a procedure needs to address the who, what, when, where, how, why of the task.

It could be one big over-arching procedure or many smaller procedures to cover each element, e.g. a clean up procedure for cleaning up glass in a production area where food is exposed. Obviously it will need address the eventuality of glass getting into food.

crude example:

stop production lines in nexus

report to QA/QC

Tape off the area to stop the spread of glass fragments

Collect exposed food from line into a box for so many feet from ground zero

Place X product on HOLD

Investigate

Perform clean up X

have QA/QC inspect/verify

 

Shorter answer is that an SOP is a procedure directly associated with a PRP that requires exacting detail to control a risk/hazard.



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#4 trubertq

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Posted 26 March 2015 - 07:39 PM

See attached files for pre requisite programme topics, plus you can add others as you see fit but the first 15 are those prescribed by Codex

Attached Files


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#5 Charles.C

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Posted 27 March 2015 - 04:52 AM

It's a rather subjective topic and there may be an accepted format for yr particular industry. :dunno:

 

Some, maybe useful, general theory/examples here -

 

http://www.ifsqn.com...g-and-examples/

 

http://www.ifsqn.com...-procedure-sop/


Kind Regards,

 

Charles.C


#6 trubertq

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Posted 27 March 2015 - 09:59 AM

Nevertheless the first 15 are those prescribed by Codex


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#7 Charles.C

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Posted 27 March 2015 - 12:22 PM

Nevertheless the first 15 are those prescribed by Codex

 

Yes ??


Kind Regards,

 

Charles.C


#8 trubertq

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Posted 27 March 2015 - 01:07 PM

I'm just saying that no matter how subjective it is these 15 are expected to be there...


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#9 Charles.C

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Posted 27 March 2015 - 03:53 PM

Oh, Right. :smile:

Actually we were probably talking at cross-purposes. I was referring to the structure of writing PRPs and SOPs.


Kind Regards,

 

Charles.C


#10 ChocoTiger

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Posted 27 March 2015 - 04:21 PM

For SQF 7.2, there are 13 "Food Safety Fundamentals" (pre-requisite programs) listed.  The names of the programs used at my company are in parentheses.

 

1) Allergen Control (Allergen Management Program)

2) Calibration of Equipment (Equipment Calibration Program)

3) Cleaning and Sanitation (Cleaning & Sanitation Program)

4) Control of Physical Contaminants (Physical Contamination Control Program)

5) Management of Pests and Vermin (Pest Control Program)

6) Monitoring Water Microbiology and Quality (Water Microbiological Testing Program)

7) Personnel Practices (Employee GMP Program)

8) Personnel Processing Practices (GMP Program and Maintenance Program)

9) Premises and Equipment Maintenance (Maintenance Program)

10) Supplier Approval (Vendor Approval Program)

11) Training of Personnel (Employee Training Program)

12) Transport and Delivery

13) Waste Management and Disposal (Waste Management Program)



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#11 xylough

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Posted 27 March 2015 - 11:11 PM

I would note that the thread and original questions here were not posed in the context of Codex A or in the context of SQF or any GFSI scheme.

Although these are venerable and robust resources, they are not universal standards for every country and every facility.

What a PRP looks like, how it relates to SOP, GMP, HACCP, HARPC, etc.,  how these are organized and how detailed they must be are highly variable in the USA (Where the original poster has indicated residence).

 

In an FDA jurisdiction facility “powder, granular, sugars, spices, and candies” as the original poster has indicated; they may receive an actual FDA inspector visit less than once a year. A far more important factor driving food safety excellence than merely being compliant with the minimal standards of 21 CFR, is to be compliant with their customer’s expectations, the demands of the customer they are co-packing for.

 

Another huge factor driving what PRP exist and how detailed they must be written are the various GMP audits that this particular facility undergoes. In the same way that SQF facilities are driven by the current SQF code, this facility must comply with the audit criteria for the audit(s) to which they are subjected. This facility may also be subject to additional demands if they supply schools or the US Armed Forces.

 

In my many FDA facilities over the years, we had as many as 70 PRP, most of which had at least 1 SOP contained therein. In the same way that HACCP and risk/hazards are highly specific to a particular facility, so may PRP be highly specific.

Continuous improvement may also drive new PRP and SOP. HACCP review may also drive new and more detailed PRP and SOP.

 

In a USDA facility there exists an onsite USDA inspector.  The inspector becomes the de facto interpreter of the applicable food code. The facility is mandated to work with this individual to comply with 9 CFR and to respond with CAPA to any non-compliance report. This relationship with the USDA and their representative inspectors may have a strong influence on the PRP and SOP quantity and quality.

Here attached is a singular take on what a PRP might look like, but it lacks document control features. I only offer it as an example of a possibility for ideas.

 

 

 

 



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#12 MWidra

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Posted 28 March 2015 - 02:23 AM

In an FDA jurisdiction facility “powder, granular, sugars, spices, and candies” as the original poster has indicated; they may receive an actual FDA inspector visit less than once a year. A far more important factor driving food safety excellence than merely being compliant with the minimal standards of 21 CFR, is to be compliant with their customer’s expectations, the demands of the customer they are co-packing for.

 

So we don't confuse the OP, I want to make it clear that his facility would not fall under USDA, but definitely is an FDA facility.  His inspection schedule should be just like ours.  Currently, our facility is considered a low risk product, and we are not required by the FDA to have a HACCP plan.  We are inspected by the FDA through the state of MD as their agent twide a year, and that frequency is probably what is required for him as well.  So perhaps the regulations have changed.

 

Once FSMA comes into play, the old GMP standard will go away.  The old GMP standard of testing for defects will be replaced with a risk-based preventative standard.  Having a HACCP plan that is compliant with the Codex is prudent.  The new FSMA plans, the new GMP as it were, will look so much like the Codex HACCP that it will only take a few minor adjustments to bring it in line.  I would recommend to the OP to apply the Codex to his processes.

 

I think that if the OP includes those PRPs from the Codex that pertain to his business, and makes sure that the scope, responsibilities, purpose and procedures are included in those plans, he should be fine.

 

Martha


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#13 Charles.C

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Posted 28 March 2015 - 07:36 AM

AGomez,

 

You may have realized by now that a unique set of, so-called, Prerequisite programs (PRPs) does not exist.

 

I suspect (but with no proof) that NACMCF in USA were the originators (1997) of a defined terminology for "Prerequisite" (PRP) as per –

 

Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.

 

The above generalized statement is expanded in the document  text.

http://www.fda.gov/F.../ucm2006801.htm

 

(Codex probably used the PRP terminology concurrently with NACMCF in their well-known Food Hygiene text but seem to have first "defined" it in their document CACRCP-52-2003 as -
 

 

Prerequisite  programme -  A  programme  that  is  required  prior  to  the application  of  the  HACCP  system  to  ensure  that  a  fish  and  shellfish processing  facility  is  operating  according  to  the  Codex  Principles  of Food Hygiene, the appropriate Code of Practice and appropriate food safety legislation..

 

The word “operational” in NACMCF definition is illustrated (but not restricted to) by NACMCF with a list of 11 programs.

 

The latest iso22002-1(for food) list has 15 PRP categories mostly aligned to those in post 4 although various sub-possibilities also exist, eg as noted in posts 3, 10.

 

Some FS standards, eg FSSC22000, define the minimum list of  PRPs which must be considered / documented / implemented. I believe the situation in US may be similar but varies between States and perhaps also within the over-riding Regulatory Authority as per  the particular Process.

 

Perhaps the OP could confirm –

 

(a) who is going to audit the facility ?

(b) do they have any (known to you) specific PRP requirements ? SOP ?

 

As per the comment in post 12, if there is no requirement for a HACCP Plan, the question as to “PRPs” may be moot. But not so for SOPs. :smile:


Edited by Charles.C, 28 March 2015 - 09:44 AM.
amended

Kind Regards,

 

Charles.C


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#14 AGomez

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Posted 14 October 2015 - 05:44 PM

It's been a while since I posted this and am still just as confused. My facility is under FDA regulation and is audited about once a year. We have a SOP book, a Quality Manual, and a HACCP Manual. Besides our FDA inspections, we go through AIB and customer required audits. Our processes are really simple and have no CCP's (based on assessment). I've attached a copy of a Process Flow Diagram and Finished Product Profile for one of our products; all our products have the same Flow and Profiles plus/minus one or two minor differences (Metal Detector usage for non-metallic lined film or the addition of a Vibratory Feed for certain products). If you look at the Finished Product Profile, I've listed our SOP's/Procedures as "Corresponding Control Measures". Will this be sufficient or should I make a whole different document for "Pre Requisite Programs" where I will pretty much copy/paste from SOP to PreReq's? Also, I am looking to have our facility BRC Certified to the GFSI Standard by Summer 2016.

Attached Files



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