Regulatory Open Forum

Health Canada has a notice dated October 31, 2017 that says the MDSAP Consortium has implemented changes to reduce the audit time. This includes:

Streamlined the MDSAP audit approach in the revised version of the audit model. This has reduced the total number of tasks to be accomplished and reduced the overall audit time;

Introduced a 10% reduction in audit time for manufacturers with 45 or fewer employees;

Introduced a 20% reduction in audit time for manufacturers with 15 or fewer employees;

Introduced a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers; and

Clarified the expectations for annual surveillance audits with the goal of reducing the audit time.

How have they done this? I infer there are, as a result, revised documents, but I don't know where they are. I usually get MDSAP documents from the FDA website, but the documents there do not seem to have the changes from the Health Canada notice?

Has any MDSAP Auditing Organization implemented the reduced times?

I found part of the answer. The document MDSAP AU P0008.005: Audit Time Determination Procedure on the FDA website (https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/ucm377580.htm) has a section on adjustments to the audit duration. In section 5.3.6.1 it says that the AO may reduce the total audit duration by up-to 20% for companies with 15 or fewer employees. Similarly, the total audit duration may be reduced by up-to 10% for companies with 16 to 45 employees.

There is also an Excel workbook MDSAP AU F0008.2.002 Audit Duration Calculation Form (Audit Model 2017) that includes a field for the adjustment factor.

The Health Canada notice is dated October 31, 2017. Reading it, I had inferred the adjustments are new, but the procedure has an effective date of August 31, 2017.

However, I don't think either the procedure or the workbook includes the provision for a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers. I wonder where this is documented.

I should note the procedure has a table with the standard times for each audit task. The workbook available from FDA has different standard times. For example, the Process and Service Controls Process has 29 tasks. The standard time in the procedure is 35.2 minutes per task and 44 minutes in the workbook.

I found part of the answer. The document MDSAP AU P0008.005: Audit Time Determination Procedure on the FDA website (https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/ucm377580.htm) has a section on adjustments to the audit duration. In section 5.3.6.1 it says that the AO may reduce the total audit duration by up-to 20% for companies with 15 or fewer employees. Similarly, the total audit duration may be reduced by up-to 10% for companies with 16 to 45 employees.

There is also an Excel workbook MDSAP AU F0008.2.002 Audit Duration Calculation Form (Audit Model 2017) that includes a field for the adjustment factor.

The Health Canada notice is dated October 31, 2017. Reading it, I had inferred the adjustments are new, but the procedure has an effective date of August 31, 2017.

However, I don't think either the procedure or the workbook includes the provision for a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers. I wonder where this is documented.

I should note the procedure has a table with the standard times for each audit task. The workbook available from FDA has different standard times. For example, the Process and Service Controls Process has 29 tasks. The standard time in the procedure is 35.2 minutes per task and 44 minutes in the workbook.

I found part of the answer. The document MDSAP AU P0008.005: Audit Time Determination Procedure on the FDA website (https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/ucm377580.htm) has a section on adjustments to the audit duration. In section 5.3.6.1 it says that the AO may reduce the total audit duration by up-to 20% for companies with 15 or fewer employees. Similarly, the total audit duration may be reduced by up-to 10% for companies with 16 to 45 employees.

There is also an Excel workbook MDSAP AU F0008.2.002 Audit Duration Calculation Form (Audit Model 2017) that includes a field for the adjustment factor.

The Health Canada notice is dated October 31, 2017. Reading it, I had inferred the adjustments are new, but the procedure has an effective date of August 31, 2017.

However, I don't think either the procedure or the workbook includes the provision for a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers. I wonder where this is documented.

I should note the procedure has a table with the standard times for each audit task. The workbook available from FDA has different standard times. For example, the Process and Service Controls Process has 29 tasks. The standard time in the procedure is 35.2 minutes per task and 44 minutes in the workbook.

Health Canada has a notice dated October 31, 2017 that says the MDSAP Consortium has implemented changes to reduce the audit time. This includes:

Streamlined the MDSAP audit approach in the revised version of the audit model. This has reduced the total number of tasks to be accomplished and reduced the overall audit time;

Introduced a 10% reduction in audit time for manufacturers with 45 or fewer employees;

Introduced a 20% reduction in audit time for manufacturers with 15 or fewer employees;

Introduced a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers; and

Clarified the expectations for annual surveillance audits with the goal of reducing the audit time.

How have they done this? I infer there are, as a result, revised documents, but I don't know where they are. I usually get MDSAP documents from the FDA website, but the documents there do not seem to have the changes from the Health Canada notice?

Has any MDSAP Auditing Organization implemented the reduced times?

I found part of the answer. The document MDSAP AU P0008.005: Audit Time Determination Procedure on the FDA website (https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/ucm377580.htm) has a section on adjustments to the audit duration. In section 5.3.6.1 it says that the AO may reduce the total audit duration by up-to 20% for companies with 15 or fewer employees. Similarly, the total audit duration may be reduced by up-to 10% for companies with 16 to 45 employees.

There is also an Excel workbook MDSAP AU F0008.2.002 Audit Duration Calculation Form (Audit Model 2017) that includes a field for the adjustment factor.

The Health Canada notice is dated October 31, 2017. Reading it, I had inferred the adjustments are new, but the procedure has an effective date of August 31, 2017.

However, I don't think either the procedure or the workbook includes the provision for a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers. I wonder where this is documented.

I should note the procedure has a table with the standard times for each audit task. The workbook available from FDA has different standard times. For example, the Process and Service Controls Process has 29 tasks. The standard time in the procedure is 35.2 minutes per task and 44 minutes in the workbook.

Health Canada has a notice dated October 31, 2017 that says the MDSAP Consortium has implemented changes to reduce the audit time. This includes:

Streamlined the MDSAP audit approach in the revised version of the audit model. This has reduced the total number of tasks to be accomplished and reduced the overall audit time;

Introduced a 10% reduction in audit time for manufacturers with 45 or fewer employees;

Introduced a 20% reduction in audit time for manufacturers with 15 or fewer employees;

Introduced a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers; and

Clarified the expectations for annual surveillance audits with the goal of reducing the audit time.

How have they done this? I infer there are, as a result, revised documents, but I don't know where they are. I usually get MDSAP documents from the FDA website, but the documents there do not seem to have the changes from the Health Canada notice?

Has any MDSAP Auditing Organization implemented the reduced times?

Mark,

Thank you. I now understand it. Based on the notice from Health Canada, I had expected a model that reduced the standard times for the audit tasks for the Initial Audit. I misunderstood.

As an aside, the workbook calculates the audit duration in "man days". I think it should be "audit days" to distinguish from "calendar days".

I found part of the answer. The document MDSAP AU P0008.005: Audit Time Determination Procedure on the FDA website (https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/ucm377580.htm) has a section on adjustments to the audit duration. In section 5.3.6.1 it says that the AO may reduce the total audit duration by up-to 20% for companies with 15 or fewer employees. Similarly, the total audit duration may be reduced by up-to 10% for companies with 16 to 45 employees.

There is also an Excel workbook MDSAP AU F0008.2.002 Audit Duration Calculation Form (Audit Model 2017) that includes a field for the adjustment factor.

The Health Canada notice is dated October 31, 2017. Reading it, I had inferred the adjustments are new, but the procedure has an effective date of August 31, 2017.

However, I don't think either the procedure or the workbook includes the provision for a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers. I wonder where this is documented.

I should note the procedure has a table with the standard times for each audit task. The workbook available from FDA has different standard times. For example, the Process and Service Controls Process has 29 tasks. The standard time in the procedure is 35.2 minutes per task and 44 minutes in the workbook.

Health Canada has a notice dated October 31, 2017 that says the MDSAP Consortium has implemented changes to reduce the audit time. This includes:

Streamlined the MDSAP audit approach in the revised version of the audit model. This has reduced the total number of tasks to be accomplished and reduced the overall audit time;

Introduced a 10% reduction in audit time for manufacturers with 45 or fewer employees;

Introduced a 20% reduction in audit time for manufacturers with 15 or fewer employees;

Introduced a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers; and

Clarified the expectations for annual surveillance audits with the goal of reducing the audit time.

How have they done this? I infer there are, as a result, revised documents, but I don't know where they are. I usually get MDSAP documents from the FDA website, but the documents there do not seem to have the changes from the Health Canada notice?

Has any MDSAP Auditing Organization implemented the reduced times?