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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