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, MDSAP Measurement, Analysis and Improvement Process Task 1 - Task 6. 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

MDSAP Measurement, Analysis and Improvement - Part 6

In today's blog we will discuss in detail about Medical Device Single Audit Program (MDSAP) CHAPTER 3 - Measurement, Analysis and Improvement Task 7 - Task 16.

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

Let's discuss in detail about Task 7 - Task 16.

TASK 7 – Assessment of

Process Change Resulting

from Corrective or

Preventive Action

Ensure that medical device organization has assessed the risks in process change due to the implemented corrective and preventive action. If necessary, the revalidation of the process should be performed.

Ensure that medical device organization is informing about the changes in the critical process (eg: Sterilization process) to the respective regulatory bodies and auditing organizations before implementing the change.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.1.2, 4.1.4, 4.1.6, 4.2.1, 7.1, 7.5.2, 7.5.6, 7.5.7

FDA: 21 CFR 820.100(a)(4), 820.100(a)(5), 820.70(b), 820.75(c)

TGA: TG(MD)R Sch1 P1 2; Sch3 P1 1.5(4)

ANVISA: RDC ANVISA 16/2013: 2.4, 5.6, 7.1.1.4

MHLW/PMDA: MO169: 5, 6, 26, 45, 46

TASK 8 – Identification and Control of Non-conforming Product

Ensure that the medical device organization has special procedure in place to identify and control the unintended use of products which does not conform to the product requirements. Verify whether the medical device organization is notifying all the external parties responsible for non-conformity of the product.

Ensure that the medical device organization has implemented the procedure for disposition of non-conforming product.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 8.3.1, 8.3.2

FDA: 21CFR 820.90(a)

TGA: TG(MD)R Sch3 P1 1.4(5)(b)(iii)

ANVISA: RDC ANVISA 16/2013: 6.5, 7.1.1.6

MHLW/PMDA: MO169: 60

TASK 9 – Actions regarding

Non-conforming product

detected after delivery

Ensure that the medical device organization has determined the procedure to control the nonconforming products detected after delivery or use, based on the risk associated with a product failure.

Decision regarding the recall of non-conforming product should be based on the justification of adequate risk.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 8.3.3, 8.5.2

FDA: 21 CFR 820.100(a)

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, 7.1.1.8

MHLW/PMDA: MO169: 60, 63

TASK 10 – Internal Audit

Ensure that the medical device organization is conducting a periodic internal audit to established the compliance of quality management system and applicable regulatory requirements.

The training efficiencies of auditors performing the internal audits should be verified by the auditing organization. The audit team should ensure that the output of internal audits is an input to management review.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 6.2, 8.2.4

FDA: 21 CFR 820.22, 820.100

TGA: TG(MD)R Sch3 P1 1.4(5)(b)(iii)

ANVISA: RDC ANVISA 16/2013: 7.3

MHLW/PMDA: MO169: 22, 23, 56

TASK 11 – Information Supplied for Management Review

Ensure that the medical device organization has supplied relevant information regarding the product non-conformities, QMS non-conformities, Corrections, Corrective actions and preventive actions to the management review.

During the audit of measurement, analysis and improvement process, determine whether the management is aware of high risk quality problems, corrective and preventive actions implemented.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 5.6.2

FDA: 21 CFR 820.100 (a)(7)

TGA: TG(MD)R Sch3 P1 1.4(5)(b)(iii)

ANVISA: RDC ANVISA 16/2013: 2.2.6, 7.1.1.7

MHLW/PMDA: MO169: 19

Task 12 – Evaluation of

Information from Post-

Production Phase, Including

Complaints

Ensure that the medical device organization has implemented procedures for post market surveillance, complaint handling, service & repair information, literature reviews, device tracking and investigating the cause of nonconformities related to advisory notices.

The risk management file shall be updated based on the Information from complaints, customer feedback, and post market surveillance.

The following details should be recorded during the investigation of non-conformity that arises in post production phase,

1. Name of the device

2. Date the complaint was received, Nature and details of the complaint.

3. Unique identifier (UDI), or Universal Product Code (UPC) or any other device identification(s) and control number(s) used

4. Name, address, and telephone number of the complainant

5. Dates and results of investigation, Any corrective action taken

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.2.1, 7.2.3, 7.5.4 (a), 8.2.1, 8.2.2, 8.5.1

FDA: 21 CFR 820.198

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

ANVISA: RDC ANVISA 16/2013: 7.2

MHLW/PMDA: MO169: 6, 29, 43, 55, 62.6

Task 13 – Communications

with External Parties

Involved on Complaints

Ensure that the medical device organization has shared and exchanged relevant information to the external parties outside the medical device organization which contributed to the complaints.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.1.5, 7.4.1, 8.3.1

FDA: 21 CFR 820.100(a)(6)

ANVISA: RDC ANVISA 16/2013: 7.1.1.6

MHLW/PMDA: MO169: 5, 37, 60

Task 14 – Evaluation of Complaints for Adverse Event Reporting

Ensure that the medical device organization has defined, documented and implemented procedures to evaluate the complaints for adverse event reporting.

Verify that the medical device organization is making a decision of not reporting a complaint to regulatory authorities with proper and valid justification.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.2.1, 7.2.3, 8.2.3

FDA: 21 CFR 803

TGA: TG(MD)R Sch3 P1 1.4(3)(c)

ANVISA: RDC ANVISA 16/2013: 7.1.1.8, RDC ANVISA 67/2009

HC: CMDR 59-61.1

MHLW/PMDA: MO169: 6, 29, 62

Task 15 – Evaluation of Quality Problems for Advisory Notices

Ensure that the medical device organization has implemented procedures for evaluation of non-conformities related to the distributed product and for potential issuance and implementation of advisory notices.

Verify whether the medical device organization has taken a decision to issue or not to issue advisory notices based on the risk associated and valid justification.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.2.1, 7.2.3, 8.3.3

FDA: 21 CFR 806, 820.100(a)

TGA: TG(MD)R Sch3 P1 1.4(3)(c)

ANVISA: RDC ANVISA 16/2013: 7.1.1.8, RDC ANVISA 23/2012

HC: CMDR 63-65.1

MHLW/PMDA: MO169: 6, 29, 60

Task 16 – Top Management

Commitment to

Measurement, Analysis, and

Improvement Process

Ensure that the medical device organizations top management provides the necessary commitment to detect and address product and quality management system related nonconformities

Verify that the top management is ensuring the continued suitability and effectiveness of the quality management system.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.1.3, 5.2, 8.1, 8.5.1

ANVISA: RDC ANVISA 16/2013: 2.2.1

MHLW/PMDA: MO169: 5, 11, 54, 62

Now I hope you have acquired some knowledge about MDSAP Chapter 3 - Measurement, analysis and improvement Task 7 - Task 16. We will discuss in detail about remaining chapters of Medical Device Single Audit Program in our future blogs.

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