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Food Safety Plan/HARPC System required?

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Posted 29 June 2016 - 09:53 PM

I’d like to pick the collective brain of this community regarding my current company's place within the confines of FSMA. I started here just over a month ago, and am...well...more than a little terrified of the amount of work that may be in front of me. Summary of my thinking for your consideration:


  1. Company is R&D driven and creates solutions, not products.​
    1. ​Products sold by Company are handled entirely by contract facilities.
      1. ​Customer gives Company money, Company requests production time at contract facility, contract facility ships product to wherever customer wants, Company pays contract facility.
    2. Ingredients purchased by Company are shipped direct from vendor to contract facility.
      1. ​Company purchases ingredients from suppliers approved by contract facility, supplier ships ingredients to contract facility.
    3. Contract facilities have their own food safety plans and quality systems in place, including:
      1. ​Supplier Approval
      2. Raw Material Approval
      3. Recall/Traceability
      4. PRP/GMP/ et cetera
  2. ​​We do not fall under the definition of a facility according to 21CFR1.227(b)(2) or Section 415 of the FD&C Act.
    1. ​we are not "engaged in manufacturing, processing, packaging, or holding food for consumption in the United States"
  3. HOWEVER (here is my headache)
    1. To keep a level of obfuscation in the process (and prevent customers from cutting us out), we refer to contract facilities as “Company Manufacturing Resources”.
    2. One location in particular is currently referred to internally and by all other contract facilities as the "Company Manufacturing" and "Company Warehouse" location.​​
    3. When receiving document requests from contract facilities around their own supplier approval processes
      1. ​Company has historically populated data as though WE were the manufacturer/warehouse, using the actual facility's data and documents, but the Company name.
      2. There is power and precedent in definitions and expectations, so it is my concern that by claiming ownership in this way on the paper trail, Company is accountable and will have to build complete FSMA compliant program.
    4. ​I am the first "real" quality director here...and there is next to nothing in place in terms of a Quality System or Food Safety anything, aside from customer service and complaints.

Option 1: Items 1. and 2. above make me think that, at most, we need to have supply chain management with strong control over our contract facilities and recall/traceability. However, we are not required by regulation to have full food safety plans and HARPC (or PCP or whatever acronym is currently preferred) systems in place for "our" products. (please note that I am speaking strictly in terms of regulatory requirements and not ethical or moral considerations - I intend to put a full system in place...but the timeline will vary significantly between option 1 and 2) This option makes sense to me, and is an achievable goal.


Option 2: Due to Item 3. above...well, that's why I'm here, asking advice! Do you believe that Company (I apologize for the placeholder...) is on the hook here? Instructors in the PCQI course I took each had differing opinions. I feel that as long as I have a logical and defensible rationale that supports my position, it can go either way. I would like to be sure my rationale is logical and defensible, though!


Thanks in advance for any insights you may offer! I hope my points above are at least as clear as mud...



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Posted 05 July 2016 - 01:45 PM

Option 1 makes good sense to me in the immediate term. HOWEVER you will want to audit your storage and manufacturing sites to ensure that a) they are following thier own plans and corrective actions implementation and deviations  and b) that there plans DO match what you require.................so then in the long term you will need at the very least ongoing audits of external sites as well as letter of guarantees in the interm. It is your company's name on the product, I wouldn't move a muscle until you have performed the external audits!

Please stop referring to me as Sir/sirs

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