Hello, this comes from the "old" NFPA- SAFE Food inspections/audits, now GMA-SAFE. The item is:
5.2 REGULATORY CONSIDERATIONS / REGULATORY & INDUSTRY COMPLIANCE AND VERIFICATION OF ASEPTIC PERFORMANCE
5.2.1 Facility products, processes, training, and records comply with applicable local, state and federal regulations.
ƒ 5.2.1.1 IDENTIFY what food regulations govern production at this facility. <<Guidance: This may include 21 CFR 113, 21 CFR 114 or other countryspecific regulations.
ƒ 5.2.1.2 DESCRIBE how the facility ensures it complies with applicable state, local and federal regulations.
ƒ 5.2.1.3 IDENTIFY who (title/position) is responsible for ensuring the facility complies with applicable state, local and federal regulations.
ƒ 5.2.1.4 CONFIRM from a review of training records whether employees are trained to understand and comply with the regulatory requirements related to their jobs.
<<Guidance: State specifically that training records were reviewed, and describe findings.
ƒ 5.2.1.5 CONFIRM from a review of regulatory records whether regulatory noncompliance issues are corrected promptly; e.g., 483s or Noncompliance Reports. <<Guidance: State specifically that regulatory records were reviewed, and describe findings.
ƒ 5.2.1.6 Does the facility use the services of a Process Authority? <<Guidance: Note the name and/or organization serving as the Process Authority.
ƒ 5.2.1.7 State the Process Authority's combined score for this plant.
ƒ 5.2.1.8 Describe general areas that caused this plant to lose points during the Process Authority's inspection.
5.3 REGULATORY CONSIDERATIONS / MANAGEMENT OF THE REGULATORY INSPECTION PROCESS 5.3.1 Management and training for the regulatory inspection process is in place.
ƒ 5.3.1.1 Does the facility have documented procedures for handling regulatory inspections?
ƒ 5.3.1.2 DESCRIBE the process for handling regulatory inspections. <<Guidance: For example, does the facility ask for and verify credentials? Notify Corporate? Accompany inspector? Take notes? Prohibit photography? Fix things immediately? Etc.
ƒ 5.3.1.3 Do procedures for handling regulatory inspections include an up-to-date list of personnel responsible for managing the regulatory process? <<Guidance: State the last revision date of the personnel list.
ƒ 5.3.1.4 Do procedures for handling regulatory inspections include 24-hour contact information for personnel responsible for managing the regulatory inspection process? ƒ 5.3.1.5 Are personnel responsible for managing regulatory compliance and/or accompanying regulatory inspectors provided specific training for this purpose? <<Guidance: DESCRIBE scope of training, if any.
5.3.2 Customers are notified if their product is not in regulatory compliance.
ƒ 5.3.2.1 Does the facility notify customers if a regulatory inspection determines the product to be out-of-compliance?
5.3.3 Duplicate samples are retained when a regulatory sample is taken.
ƒ 5.3.3.1 Do regulatory inspection procedures require duplicate samples be collected when samples are taken by the regulator?
ƒ 5.3.3.2 Are production lots represented by the regulatory sample held pending results?
ƒ 5.3.3.3 Does the facility notify customers when a regulator evaluates that customer's product? <<Guidance: If notified, explain how and by whom (title/position).
ƒ 5.3.3.4 DESCRIBE examples from record reviews that verify regulatory inspection procedures are followed. <<Guidance: State specifically that records were reviewed, and describe findings.
5.3.4 Duplicate copies of documents given to regulatory authorities concerning a customer's product are made.
ƒ 5.3.4.1 Does the facility notify customers when a regulator is given copies of written documents pertaining to its products? <<Guidance: If notified, explain how and by whom (title/position).
ƒ 5.3.4.2 DESCRIBE examples that verify procedures are followed. <<Guidance: State specifically that records were reviewed, and describe findings
Hope this helps,
Best regards,
Leila
