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FSPCA Instructor Guide 2The PCQI Training course…

Having attended the FSPCA Lead Instructor course for Preventive Controls of Human Food, I thought I would share my experiences and learnings with you. While attending the course I was keen to find out the answers to the following questions:

  • Why the FDA had not used HACCP principles.

  • How this type of hazard analysis differs from HACCP/ what does it do that would be better or above and beyond HACCP

  • How this system can fit together with the current food safety systems (such as HACCP) that are already in use.

I have to be honest that I found the first day and a half of the course a little frustrating, mainly because I couldn’t get the answers I was looking for.  But, about half way through the second day I had a little bit of a realisation or ‘light bulb’ moment…

I realised that straight answers to the questions I was looking for didn’t exist. The FDA have not used the current HACCP system, not for any particular reason (that they will share with us) – but just because they haven’t. The FDA system includes the term preventive controls, but this doesn’t add a whole lot of extra value in comparison to a facility that runs an effective and well-managed HACCP system. Therefore, the FDA have not said how their system would fit with current HACCP systems – as they haven’t taken this into consideration.

This means, that the FDA have not defined what the difference is between a preventive control and a CCP.  And it also means, that where they have not defined things like this – it is totally acceptable for us to ‘fill in the gaps’ for ourselves. The key point here, is that when we do this – we must be able to justify our reasoning.

Once I came to terms with this, it made understanding the rule and how it should be applied so much easier. Below are the main things I learnt from the course and the key points that stood out to me.

A food safety plan of many parts

The example in the PCQI training suggested that it would be a good idea to split the food safety plan out into essentially 4 risk assessments:

  1. Process hazard analysis
  2. Supply-chain hazard analysis
  3. Allergen hazard analysis
  4. Sanitisation hazard analysis

So basically, you would carry out the process hazard analysis using a process flow chart.  The supply chain hazard analysis would assess the risk from the raw materials and suppliers. The allergen hazard analysis is essentially an allergen risk assessment. The sanitisation hazard analysis, would assess the equipment to be cleaned and also the facility (zones needed).

Just because it’s not in the rule – doesn’t mean it’s not required

Although the rule is specific about certain things, it doesn’t give you all the tiny details of how things should be done.  The facility is expected to decide ‘when enough is enough’.

So for example, the rule doesn’t say you need a process flow chart.  But, the PCQI training, includes a section which teaches you the advantages of using a process flow chart. Therefore, as a qualified individual you would need to decide whether a process flow chart is needed.

There are a number of instances where this is the case.  The rule states the requirements for supply-chain control in just a few of sentences. However, the PCQI training goes into detail about the types of controls that could be put in place to comply.  It’s therefore up to the PCQI to decide the level of control that should be applied, and then hope that the FDA inspector when they arrive agrees.

2 types of preventive controls

There are actually two types of preventive controls taught in the PCQI training:

  • Process preventive controls
  • Non-process preventive controls

There is no set definition however of what makes a process preventive control.  It was implied that a process preventive control is one that is determined when carrying out hazard analysis of the process and occurs at a particular process step.

But it was also said that perhaps a process preventive control would not sit under the umbrella of the following:

  • Supply-chain preventive controls
  • Allergen preventive controls
  • Sanitisation preventive controls

We know though, that some allergen and sanitisation controls would occur at particular process step, so this doesn’t really make sense.

All preventive controls need monitoring, but only process preventive controls need validating. Basically, a process preventive control is a CCP.  But how we determine which are process preventive controls (or CCPs) is up to us – as long as we can justify our reasoning.

Terminology for Cross-contamination

The term cross-contamination should only be used when referring to cross-contamination of microbiological contamination. When referring to cross-contamination of allergens, the term cross-contact should be used.

There is no specific term for cross-contamination of physical or chemical contamination, but neither cross-contamination or cross-contact should be used.

Correction or Corrective Action?

Within the rule the FDA have defined what is meant by a correction and a corrective action.   Unfortunately, the definitions are different to those recognized currently, or those used by GFSI recognized standards.

Correction:  The FDA deem a correction to basically be an adjustment.  If the process is starting to go out of control and it is recognized and then ‘corrected’ before it goes out of control – this is a correction.  If a clean is completed and when it’s checked, the clean is found to be inadequate and so it is ‘corrected’ by being re-cleaned – this is a correction.  For this reason, corrections do not need to be recorded.  For many GFSI recognised schemes not recording this type of correction would not be acceptable.

Corrective action:  Any action that is carried out when the process is out of control, or out of the defined limits. The FDA see corrective action to include all types of action – so this would include correction, corrective/preventative action and also root cause analysis.

The difficulty for facilities now trying to work to both FSMA and GFSI standards is that the terminology is going to be contradictory in many cases.  Therefore, it would be wise to decide what terminology and definitions you are going to use and document these – so it can be justified if challenged during an inspection.

Allergens & Cleaning

Cleaning that is carried out to either remove microbial contamination or allergenic contamination needs to be checked once complete, but the rule only requires a visual check to be carried out.   No validation or other verification is needed by law.

This obviously doesn’t sit well with me, as it doesn’t make any sense and I think it gives totally the wrong impression – by implying that microbial or allergenic contamination can be ‘seen’.

One of the other delegates on the course made a very good point – although the rule shouldn’t say you must do it, if it was to go wrong and somebody was to become ill because of it, would you be able to provide a solicitor with enough evidence to stand up in court to protect you without carrying out validation and further verification of the cleaning?

There are many instances in the rule, where the law doesn’t actually state that things must be done, but it expects the facility to decide when they have done enough to protect the customer.

Zones

The FDA now expect the facility to be assessed to establish was zone class each area should be.  The zones and the definitions are as follows:

Non-manufacturing areas:  maintenance/engineering workshop, offices, employee areas, waste disposal.
Transition areas: entry rooms, locker rooms that enter onto basic GMP areas etc.
Basic GMP areas:  raw materials, receiving and storage (raw materials and product could be open).

Primary pathogen control area (controlled access) – cooked, pasteurised or RTE products exposed to the environment.
Sensitive/ high hygiene area (restricted access) – products for sensitive populations such as infants and allergy sufferers

Again, the above does not gel well with GFSI recognised schemes, for example BRC have defined zones which do not match the above definitions:

  • Non-production areas: FDA non-manufacturing areas and transition areas.
  • Enclosed product areas: no FDA match – this would be basic GMP areas where product is not open.
  • Low risk areas: again no exact FDA match – this would be basic GMP areas where the product is open.
  • High risk areas: no exact match – this would be included in the primary pathogen control area.
  • High care areas: no exact match – this would also be included in the primary pathogen control area.
In the next few posts I’m going to go through each of the preventive controls for supply-chain, allergens, sanitisation and also recall to assess the requirements and the differences from BRC. As always, if you have any questions please just add them to the comments below and I’ll get back to you.

6 Comments

  • Andreas says:

    Hi kassy, I also just completed the PCQI training and are in complete agreement with you about the vagueness of the regulations. It would appear the FDA, with out regard for systems in place, introduce controls that not only confuse but contradict established protocols. However with BRC or GSFI certified plants it will not be difficult to adjust to the FDA proposals. I fear for the small company of ten or less employees. These are the artisans from which great company’s grow.
    I enjoy your most informative blogs. We think alike in reasoning, logic, and common sense.
    Thanks so much.

  • Hien says:

    Thanks Kassy very much for sharing. I learn so much more in this blog from you than what I learned from the 2 instructors that I had for 2.5 days .

    HT

    • Kassy Marsh says:

      Hi HT, you’re very welcome! I’m hoping I can develop a PCQI e-learning course before Christmas, which will be as easy to follow…
      Thanks, Kassy

  • Kassy – great article. Have you been able to do the PCQI e-learning and/or done any more posts on each of the preventative controls as you mentioned? Andy

    • Kassy Marsh says:

      Hi Andy,
      Thank you. We’re just finishing off our food fraud eLearning course and then I’m moving on to PCQI and HACCP for our next courses.
      I have written other posts on PC’s, you can see all the posts on FSMA here: FMSA Articles
      Thanks
      Kassy

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