12 replies to this topic

[HokeyPokey]

Our Certification Body told us that we need to have a person trained in PCQI before our SQF audit.  Does anyone know anything about this. PCQI is for "Preventive Control Qualifed Individual" this is a requirement for FSMA.  I never hear anything about this.

 

HELP.

[FurFarmandFork]

Hi Hokey Pokey,

 

FSMA guidance covering this issue can be found here: https://www.fda.gov/...A/ucm247559.htm

 

 

 

PC.5 What is a preventive controls qualified individual?
This is a new term in the final rule. A preventive controls qualified individual is someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system. The written food safety plan required of food facilities must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. And the preventive controls qualified individual is charged with overseeing the validation that preventive controls are capable of controlling identified hazards and the records review. 

 

Because you weren't already aware of this requirement, I would highly recommend that you attend a training to satisfy the requirements of the law and be sure your auditors will find you qualified, and you'll learn a lot in the process! Right now, the only training FDA has "approved" is that provided under the FSPCA curriculum. You can go to their website to find a training near you. 

[HokeyPokey]

What is the differ between HACCP Training and PCQI Training after looking into this alot of the information look the same.

[FurFarmandFork]

If you've been through HACCP training then it will feel extremely familiar. The hazard analysis step is exactly the same, but the implementation/paperwork of your plan will change, and the preventative controls requirement is new.

 

It sounds like you're pretty unfamiliar with the new requirements for preventative controls added by FSMA, I woul again highly recommend the training, they'll help explain the differences and determine which parts of your existing HACCP plan will need to change and which ones can stay.

 

As far as it being required by SQF, basically since it's required by FDA it falls under the "must meet regulatory requirements" clause in module 2.

[Charles.C]

If you've been through HACCP training then it will feel extremely familiar. The hazard analysis step is exactly the same, but the implementation/paperwork of your plan will change, and the preventative controls requirement is new.

 

It sounds like you're pretty unfamiliar with the new requirements for preventative controls added by FSMA, I woul again highly recommend the training, they'll help explain the differences and determine which parts of your existing HACCP plan will need to change and which ones can stay.

 

As far as it being required by SQF, basically since it's required by FDA it falls under the "must meet regulatory requirements" clause in module 2.

 

 

Hi 3F,

 

I'm intrigued. How is the training made familiar when the basic HARPC requirements for the hazard analysis step have (radically?) changed? .

 

IMHO, performing the hazard analysis stage is one of the most difficult parts of the development of a HACCP plan. And one of the most important. Unfortunately many textbooks attempt to do it by "rote" to make it look simple. Unless perhaps you have a very low risk situation, IMEX it isn't.

[adamperry2235]

Did they reference any particular section which requires this? I had a pre inspection audit and my auditor never brought it up. The only things i can see in the guidelines are in reference to HACCP and that is talking about the SQF Practitioner. I would love to know if there is a rule somewhere that states this so I can get the training done before we go for our cert. 

[FurFarmandFork]

Relevant portions of the code:

2.4.1.1 The organization shall ensure that, at the time of delivery to its customer, the food supplied shall comply with the legislation that applies to the food and its production in the country of its origin and destination. This includes compliance with legislative requirements applicable to maximum residue limits, food safety, trade weights and measures, packaging, product description, nutritional, allergen and additive labeling, and to relevant established Industry codes of practice. 2.4.1.2 The methods and responsibility for ensuring the organization is kept informed of changes to relevant legislation, scientific and technical developments and relevant industry codes of practice shall be documented and implemented.

 

2.9.1.1 Appropriate training shall be provided for personnel carrying out the tasks critical to the effective implementation of the SQF Level 3 System and the maintenance of food safety, regulatory requirements, and quality.

 

2.1.1 guidance (management policy)

• Activities within the facility meet regulatory and customer expectations.

 

Essentially it's a blanket that if it's a regulatory requirement, you should be meeting it to comply with 2.4.1.1.

 

@Charles

 

I agree that the hazard analysis step is the most difficult and most important. But if you've been doing an honest and thorough hazard analysis under HACCP, the process remains the same. The difference is that if the hazard is controlled by a pre-requisite program now covered as a preventive control (specifically supplier control, allergen control, sanitation control), it's now included in the final written hazard analysis and HACCP summary rather than assumed controlled by those programs, and instead of saying "if prerequisites are followed, this hazard is effectively reduced or eliminated", you state something akin to "preventative control: supplier approval program" and indicate the monitoring and verification events associated.

[adamperry2235]

So maybe this isn't relevant to your situation HokeyPokey, but I just spoke with my CB. The person I spoke with told me that you shouldn't need a PCQI to obtain your SQF certification but you will need one to be compliant with FSMA. So depending on when your company has to be compliant that may be why they are suggesting that. I only made that call because we are looking to obtain our SQF Level 2 cert in the next few months. I was interested to see if we had to obtain that training before the audit. 

[Charles.C]

 

@Charles

 

I agree that the hazard analysis step is the most difficult and most important. But if you've been doing an honest and thorough hazard analysis under HACCP, the process remains the same. The difference is that if the hazard is controlled by a pre-requisite program now covered as a preventive control (specifically supplier control, allergen control, sanitation control), it's now included in the final written hazard analysis and HACCP summary rather than assumed controlled by those programs, and instead of saying "if prerequisites are followed, this hazard is effectively reduced or eliminated", you state something akin to "preventative control: supplier approval program" and indicate the monitoring and verification events associated.

 

Hi 3F,

 

Sorry, I should have been more explicit. This is the harpc "change" I was referring to in Post 5 -

 

http://www.ifsqn.com...ha/#entry111485

 

Curiously the FSPCA manual after its initial FSMA def. of "hazard requiring a preventive control" makes, afai can see, no further ref. to this "change". The latter's text has also conveniently disappeared in the summary "defs". at end of chapter 8.

 

Various literature publications have subsequently pointed out the potential significance of the change. It has been previously discussed here but any official conclusion, if one exists, is, afai know, unknown. Maybe you have to be a PCQI(+) to find out.

[SQFconsultant]

Even though it is wise to get the PCQI training I would suggest you go back to your CB and ask them for something in writing showing that in order to meet SQF requirement somebody needs to be a PCQI.

Look, it really does make sense to get the training and comply with the FSMA rules however what you want is something in writing as to the requirement by SQF for this. And please, if they can provide it post it here.

[dahna4me]

So maybe this isn't relevant to your situation HokeyPokey, but I just spoke with my CB. The person I spoke with told me that you shouldn't need a PCQI to obtain your SQF certification but you will need one to be compliant with FSMA. So depending on when your company has to be compliant that may be why they are suggesting that. I only made that call because we are looking to obtain our SQF Level 2 cert in the next few months. I was interested to see if we had to obtain that training before the audit. 

 

I think you should refer to FurFarmandFork's post # 7!  AFAI know, per 2.4.1.1 of the SQF code, if the "organization does not ensure food supplied complies with the food safety legislation that applies to the food and its production in the country of its origin" this would be cited as a non-conformity.

[Ryan M.]

Three things:

 

Number 1:

• While a HARPC is required for companies there are exceptions.  If you are considered a small business, as defined in part 117.3 of CFR, then you h ave until 9/18/17 to be compliant with HARPC.
• If you are a dairy processor then you have until 9/17/18.
• If you fall under another type of HACCP legislation such as seafood or juice HACCP you are not required to have HARPC in place.

Number 2:

• SQF requires you to follow local and countries of destination legislation.  So you have to first evaluate if HARPC currently applies to your facility, either you produce in the US or, if you export to the US you have to follow the FSVP (Foreign Supplier Verification Program).  The latter does not require you to specifically implement HARPC, but that you have certain programs in place that are equivalent.
• If HARPC is NOT required by definition no one needs PCQI certification.

 

Number 3:

• HARPC is similar to HACCP with the exception of the hazard analysis and specific controls that are required to be implemented and validated.  In the HARPC plan you must identify reasonably potential hazards from the material and/or process without having any controls in place to mitigate the hazards.  HACCP you do the hazard analysis and take into account the controls that mitigate the hazard.  So, this is quite different.
• Secondly, with HARPC you must have a minimum of four controls in place: process controls, sanitation controls, allergen controls, and supplier controls.  IT does also require you to have to have a recall plan in place.

 

I hope this helps to clarify as HARPC can be quite confusing.  Leave it to the US government to make the simple things complicated and the not so simple things almost impossible to understand.  Just wait until this regulation blows up into a 2000 page document in a few years....joy.

[FurFarmandFork]

I'm now summarizing it this way when people ask if they should get PCQI training.

 

1. Does the preventative controls rule apply to your company?

Yes> go to step 2

 

No> Don't worry about it, just make sure you file whatever paperwork is needed for your exemption.

 

I don't know> Have a consultant answer the question for you. If the answer is yes, you need to do the training. Your existing training/experience did not give you the qualifications read and interpret the law/guidance to answer this question on your own, so it's hard to say you qualify without the additional training to help you understand and implement the requirements. If the answer is no, see No above.

 

2. Are you able to find the answers to your FSMA questions in the FDA guidance or final rule?

Yes> You might consider PSCI training just to make sure there's no question you're meeting the requirement, but you have demonstrated the know-how to read, interpret, and implement the rule, and thus may qualify based on education/experience.

 

No>  Your existing training/experience did not give you the qualifications read and interpret the law/guidance to answer this question on your own, so it's hard to defend that you're qualified to be a PCQI without additional training.

 

 

----

 

HACCP training has a similar flow, where someone who couldn't find the abundant resources available online to help you conduct a hazard analysis for a non-specialized product will greatly benefit from an official training to get direct instruction on the material, while someone else may just take the class for additional insight or to make sure a certification scheme requirement was met.