tcoffin,
As I learned from a previous bout with an auditor about PCQI. Auditor said certification was needed to be PCQI. Through the help / guidance from FDA web site and by the guidance of the individuals here om IFSQN it basically is not true and what it all comes down to is experience and that you have the competency to maintain, update, implement, audit the SQF System.. I have listed below the exact information I submitted to the auditor in my bout about being certified & not have to being certified. Again if you have the experience, the knowledge and the understanding and it shows in your work. You will be fine.
The following are questions and answers related to the Food Safety Modernization Act (FSMA).
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.
PC.6 Do I need to employ a preventive controls qualified individual (PCQI)?
The preventive controls for human food rule creates new requirements for covered domestic and foreign facilities producing human food to develop and implement a food safety plan based on hazard analysis and risk-based preventive controls. In general, the rule applies to facilities that have to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, there are a number of exemptions and modified requirements that may apply (see 21 CFR 117.5 for exemptions that may apply to your facility).
If no exemptions apply to you, then you are required to have a PCQI develop and implement your facility’s food safety plan. A PCQI is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.
PC.7 How does a PCQI demonstrate that he or she is qualified to serve as a PCQI?
The preventive controls for human food final rule specifies that a PCQI is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.
However, the rule does not require any specific certifications, including certification by the Food Safety Preventive Controls Alliance (FSPCA). An individual may voluntarily choose to attend the PCQI training provided through the FSPCA, but this is not mandatory. In general, FDA will assess the adequacy of a facility’s food safety plan rather than an individual’s documented qualifications. Deficiencies in the food safety plan indicate that a PCQI may need additional training specific to the rule, irrespective of documented training and experience.
PC.8 I have many food safety certifications (HACCP, GFSI, SQF, BRC, etc). Do I still need to take the PCQI training from the FSPCA?
The preventive controls for human food rule specifies that a PCQI is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.
There are some differences in the requirements of the CGMP & PC rule compared to the requirements of HACCP regulations and other preventive-based food safety programs such that the training provided by the International HACCP Alliance/GFSI/SQF/BRC etc or other institutions might not be equivalent. Such an individual may need additional training specific to the CGMP & PC rule. However, the CGMP & PC rule does not require any specific certifications, including certification by the FSPCA. In general, FDA will assess the adequacy of a facility’s food safety plan rather than an individual’s documented qualifications. Deficiencies in the food safety plan indicate that a PCQI may need additional training specific to the rule, irrespective of documented training and experience.
PC.9 I have worked as a food safety manager for a very long time. Do I need to take PCQI training, or does my job experience satisfy the requirements to be a PCQI?
The preventive controls for human food final rule specifies that a PCQI is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.
In general, FDA will assess the adequacy of a facility’s food safety plan rather than an individual’s documented qualifications. Deficiencies in the food safety plan indicate that a PCQI may need additional training specific to the rule, irrespective of documented training and experience.