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.Go to the full post