Procedure for management of external inspections and regulatory visits

Hello,

A documented procedure must exist for the management of external inspections and regulatory visits.

Must it?

Buy lots of sandwiches and nice coffee :giggle:

Must it?

 

Buy lots of sandwiches and nice coffee :giggle:

:rofl2:

Yes it is  requirement in IFS food  and I need documented procedure to meet  this  requirement

Not all encompassing, but include: 

1. Actions that front office personnel must take (make auditor sign in, ask for credentials, don't let auditor wander the site)

2. Policy on swabbing, photography - that will be up to you, but good idea to take duplicate swabs and photographs

3. All auditors should be subject to your site's GMPs

4. Guideline on how employees are to communicate with auditors (depends on jurisdiction and government)

5. Guidelines on how to respond to findings and when to contact legal counsel, along with contact information for your counsel

Different country, different audit scheme, and likely different industry, but this Inspection Guide from PMA for FDA inspections might be a good starting point for you.  I found it well-rounded and useful as a starting point.  https://www.pma.com/...-the-fda-knocks

Anyway, good luck,

Todd

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