Hi friends!!!

In our previous blog we had a introduction about Medical Device Single Audit Program, MDSAP Audit Cycle, Management process Audit, Device marketing authorization and facility registration. Please check out for the link below.

Medical Device Single Audit Program - Part 1

MDSAP Audit Cycle - Part 2

MDSAP Management Process Audit - Part 3

MDSAP Management Process Audit - Part 4

MDSAP Device Marketing Authorization and Facility Registration - Part 5

In today's blog we will discuss in detail about Medical Device Single Audit Program (MDSAP) CHAPTER 3 - Measurement, Analysis and Improvement.

MDSAP is a common Medical Device auditing program followed by countries like Australia, USA, Brazil, Canada and Japan. Therefore it is important for every healthcare professionals who wish to market their product in the above mentioned countries to know in detail about MDSAP.

Let's get into the topic.

CHAPTER 3: MEASUREMENT,

ANALYSIS AND IMPROVEMENT

The following are the tasks involved in the audit of Measurement, Analysis and Improvement process.

TASK 1 – PROCEDURES FOR

MEASUREMENT, ANALYSIS, AND

IMPROVEMENT OF QMS EFFECTIVENESS AND PRODUCT CONFORMITY

TASK 2 – SOURCES OF QUALITY DATA

TASK 3 – INVESTIGATION OF

NONCONFORMITY

TASK 4 – INVESTIGATION OF POTENTIAL

NONCONFORMITY

TASK 5 – CORRECTION, CORRECTIVE

ACTION, AND PREVENTIVE ACTION

TASK 6 – ASSESSMENT OF DESIGN CHANGE

RESULTING FROM CORRECTIVE OR

PREVENTIVE ACTION

TASK 7 – ASSESSMENT OF PROCESS

CHANGE RESULTING FROM CORRECTIVE

OR PREVENTIVE ACTION

TASK 8 – IDENTIFICATION AND CONTROL

OF NONCONFORMING PRODUCT

TASK 9 – ACTION REGARDING

NONCONFORMING PRODUCT DETECTED

AFTER DELIVERY

TASK 10 – INTERNAL AUDIT

TASK 11 – INFORMATION SUPPLIED FOR

MANAGEMENT REVIEW

TASK 12 – EVALUATION OF INFORMATION

FROM POST-PRODUCTION PHASE,

INCLUDING COMPLAINTS

TASK 13 – COMMUNICATIONS WITH

EXTERNAL PARTIES INVOLVED ON

COMPLAINTS

TASK 14 – EVALUATION OF COMPLAINTS

FOR ADVERSE EVENT REPORTING

TASK 15 – EVALUATION OF QUALITY

PROBLEMS FOR ADVISORY NOTICES

TASK 16 – TOP MANAGEMENT

COMMITMENT TO MEASUREMENT,

ANALYSIS, AND IMPROVEMENT PROCESS

Let's discuss in detail about each task.

Task 1 – Procedures for

Measurement, Analysis, and

Improvement of QMS Effectiveness

and Product Conformity

Ensure that medical device organizations has established and documented the procedures for measurement, analysis and improvement addressing the requirements of the QMS standard and other applicable regulatory authorities. Ensure that the medical device organization maintains and implements the necessary procedures to monitor and measure product conformity throughout the product realization.

The following are some of the requirements of procedures to analyze the data and to implement corrective action and preventive action.

1. The nonconformities shall be reviewed, including customer complaints

2. There should be a provision to record the results of any investigations and of actions taken

3. Ensure that the corrective action and preventive action taken is effective and does not adversely affect the finished device

4. Required changes in methods and procedures needed to correct and prevent the identified quality problems should be Implemented and recorded

Verify the medical device organizations procedures which provide mechanisms for feedback. The feedback is required to provide early warnings of quality problems and the implementation of corrective action and preventive action.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.2.1, 8.1, 8.2.1, 8.2.6, 8.5

FDA: 21 CFR 820.100(a)

TGA: TG(MD)R Sch3 P1 1.4(3)(a),(b), (5)(b)(iii), (f)

ANVISA: RDC ANVISA 16/2013: 5.3.1, 7.1, 7.2

MHLW/PMDA: MO169: 6, 54, 55, 58, 62, 63, 64

Task 2 – Sources of quality data

Ensure that medical device organization has identified and analyzed the appropriate sources of quality data according to a documented procedure for use of valid statistical methods (where appropriate) as a input into the measurement, analysis and improvement process.

The source of quality data may come from following ways but are not limited to customer complaints, returned product, internal and external audit findings, suppliers, feedback, nonconformities from regulatory audits and inspections, service records and data from the monitoring of products, processes, nonconforming products.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 7.5.4, 8.1, 8.2.1, 8.2.6, 8.4

FDA: 21 CFR 820.100(a)

TGA: TG(MD)R Sch3 P1 1.4(3)(a),(b), (5)(b)(iii), (f)

ANVISA: RDC ANVISA 16/2013: 7.1.1.1, 9.1

MHLW/PMDA: MO169: 43, 54, 55, 58, 61

Ensure that the medical device organization has used appropriate statistical methodology to detect recurring quality problems. And also ensure that medical device organization has not misused statistics in an effort to minimize the problem or avoid addressing the problem.

Task 3 – Investigation of

Nonconformity

Verify whether medical device organization has made necessary investigations to identify the underlying causes of detected nonconformities wherever possible.

The organization should define and implement a risk-based approach for investigating complaints and non-conformities. The roles and responsibilities, timelines should be well defined.

The auditing person shall select the records of investigations where the nonconformity of product has a higher risk.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 8.5.2

FDA: 21 CFR 820.100 (a)(2)

TGA: TG(MD)R Sch3 P1 1.4(3)(a),(b), (5)(b)(iii),(f), TG(MD)R Sch1 P1 2

ANVISA: RDC ANVISA 16/2013: 2.4, 6.5.1, 7.1.1.2

MHLW/PMDA: MO169: 63

Task 4 – Investigation of Potential

Nonconformity

The core content of Task 4 is similar to Task 3.

Verify the depth and extent of investigations conducted to identify the underlying causes) of potential nonconformities, wherever possible.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 8.5.3

FDA: 21 CFR 820.100(a)(2)

TGA: TG(MD)R Sch3 P1 1.4(3)(a),(b), (5)(b)(iii),(f),TG(MD)R Sch1 P1 2

ANVISA: RDC ANVISA 16/2013: 2.4, 7.1.1.1

MHLW/PMDA: MO169: 64

Task 5 – Correction, Corrective

Action, and Preventive Action

Ensure that the medical device organization has determined, implemented, documented all the corrections, corrective actions, preventive actions and made it effective. Verify that the medical device organizations corrections, corrective actions, and preventive actions did not adversely affect the finished devices.

Ensure that the medical device organizations corrective action and preventive action is appropriate to the risk of potential nonconformities encountered.

The medical device organization shall perform corrections regarding the affected products, whether it is distributed or not.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 8.2.1, 8.2.5, 8.3.1,8.5.2, 8.5.3

FDA: 21 CFR 820.100(a)(3), 820.100 (a)(4),820.100(a)(6), 820.100(b)

TGA: TG(MD)R Sch1 P1 2, TG(MD)R Sch3 P1 1.4(3)(a),(b), (5)(b)(iii), (f)

ANVISA: RDC ANVISA 16/2013: 2.4, 6.5, 7.1.1.3, 7.1.1.4, 7.1.1.5

MHLW/PMDA: MO169: 55, 57, 60, 63, 64

Task 6 – Assessment of Design

Change resulting from Corrective

or Preventive Action

Ensure that the medical device organization has evaluated new hazards and any new risks under the risk management process when their corrective or preventive action results in a design change.

Ensure that the medical device organization has performed verification and validation activities to make sure that their corrective and preventive actions does not introduce any new hazards.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO: ISO 13485:2016: 7.1, 7.3.9

FDA: 21 CFR 820.30(i), 820.30(g)

TGA: TG(MD)R Sch1 P1 2

ANVISA: RDC ANVISA 16/2013: 2.4, 4.1.10

MHLW/PMDA: MO169: 26, 36

Now I hope you have acquired some knowledge about MDSAP Chapter 3 - Measurement, analysis and improvement. We will discuss in detail about remaining tasks of Medical Device Single Audit Program Chapter 3 in our future blogs.

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