Case for Quality Company D

Risk Management

Risk Management

2

Introduction to Risk Management procedure at Company X

Establishes requirements for

Risk Management of Medical Devices

with regards to Safety

for patients, medical device users, and other persons (as well as property and the environment).

Risk – Combination of the probability of occurrence of harm and the severity of that harm. [ISO 14971]

Risk Management – Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk. [ISO14971].

Safety – Freedom from unacceptable risk. [ISO 14971]

People exposed to medical devices after

production.

Risk Management

3

Scope of Procedure Applies throughout the entire lifecycle

of medical devices

and medical systems

for which Company X is the manufacturer

Lifecycle – All phases in the life of a medical device, from the initial conception to final decommissioning and disposal. [ISO 14971]

Medical Device – Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of (1) diagnosis, prevention, monitoring, treatment or alleviation of disease, (2) diagnosis, monitoring, treatment, alleviation of or compensation for an injury, (3) investigation, replacement, modification, or support of the anatomy or of a physiological process, (4) supporting or sustaining life, (5) control of contraception, (6) disinfection of medical devices, (7) providing information for medical purposes by means of in vitro examination of specimens derived from the human body; and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. [ISO 14971]

Medical system – System containing at least one medical device

Risk Management

4

Risk Management Team – Team responsible for the review of risk management activities (within a defined scope).

The Risk Management Team is a subset of the Project Team (both pre-launch and post-launch)

Typical roles: Quality Engineer, Design Engineer, Manufacturing Engineer, Marketing Rep, Clinical Affairs Rep, Regulatory Affairs Rep.

Risk Management Board (RMB) – Designated group of subject-matter experts and managers who have responsibility for the supervision of all Risk Management activities at Company X including authorization to balance medical benefits against residual risks to make final decisions regarding the acceptability of Overall Residual Risk (ORR).

Key Terms

Risk Management

5

Risk Table Risk Table – Main table for documenting risk analysis, risk evaluation, and risk control activities.

01 02 03

04 05 06 07 08

09 10 11

Risk

ID #

Functional

Output Hazard

Hazardous

Situation Harm

Person

Affected Causes

Planned/Existing

Risk Control

Measures

Severity

Level

(SHARM)

Occurrence

Level

(OHARM)

Risk

Region

12 13 14 15 16 17 18

Additional Risk

Control Measures

Revised

Occurrence

Level

(OHARM)

Revised

Risk

Region

Risk/Benefit Analysis

(required for

High/Medium risks)

Verification of Risk

Control Measures

(Implementation)

Verification of Risk

Control Measures

(Effectiveness)

Comments/

Rationale (if

necessary)

Risk Management

6

Risk Analysis

Risk Evaluation

Risk Control

Production and Post Production Monitoring

ORR Evaluation

LAUNCH

Risk

Management

procedure

Risk Analysis Techniques

work instruction

Critical Quality Attributes

work instruction

Risk Management

Board

work instruction

Post-Market (Health) Risk Assessment

work instruction

1

2

3

4

5

Risk Management Process: 5 Elements

Risk Management

1

2

Risk Management Process Flow

Risk Management

Yes

Is risk control complete?

(Are all hazards accurately

considered?)

Is further individual risk

reduction necessary or

possible?

Are new hazards/hazardous

situations introduced or existing

risks affected due to additional

risk control measures?

No

Document additional risk

control measure(s)

Overall Residual Risk is acceptable.

Complete Risk Management Report

Risk

reduceable by

inherently safe

design?Risk reduceable by

protective measures in the

device or mfg process?

Risk reduceable by

Information for Safety?

Yes

Yes

Risk reduceable by

restriction of

Intended Use?

Restrict the

Intended Use

(Project Strategy)

Yes

Is further risk

reduction

possible?

Risk Management

Board

No

Yes

Is the

Overall Residual Risk

Acceptable?

Is

re-assessment of risk

necessary?

Ris

k C

on

tro

lO

ve

rall R

es

idu

al R

isk

Ev

alu

ati

on

5

Pro

du

cti

on

an

d

Po

st-

Pro

du

cti

on

Mo

nit

ori

ng

Yes

1

Yes

Yes

Risk Control

Option Analysis

LAUNCH

3

Consult Risk

Management Board

Do medical

benefits outweigh

Overall Residual

Risk?

No

Yes

No

Yes

No

2

No

No

No

4

2

9.4.1

9.4.1

9.4.1

9.4.1

9.4.1

9.4.1

9.4.1

9.4.3

9.4.6

9.5.1 9.5.2

9.5.4

9.6.1

9.4.7

Verify implementation of all risk control measures

Go to

From

Go to

Go to

Go to

From 9.4.5

9.5.3

1

3 2

5

3

9

1

3 2

5

3

9

DR6

Estimate the residual risk assuming

all (planned/existing and additional)

risk control measures will be

implemented

Do medical benefits

outweigh the individual

residual risk?

No

Risk is

unacceptable.

Abort project.

No

Yes

Identify and communicate

failure criticality information pertaining

to risk control measures

DR9

DR10

Review production and post-production information

No

No

9.4.1

9.4.2

Is RMB approval

required?

No

Yes

Yes

9.4.8

Residual risk is judged acceptable

(pending verification)

Individual residual risks are acceptable

9.5.2

Ensure RMF is

released.

9.4.2

9.4.2

9.4.4

9.5.2

9.5.4

9.6.2

9.6.3

9.4.8

DR79.4.6

9.4.7

1 1

7 2

1

1

8

2

Risk Management Process

Part II

Verify effectiveness of all risk control measures

Risk Management Process Flow

(contd.)

3

4

5

Risk Management

Yes

Is risk control complete?

(Are all hazards accurately

considered?)

Is further individual risk

reduction necessary or

possible?

Are new hazards/hazardous

situations introduced or existing

risks affected due to additional

risk control measures?

No

Document additional risk

control measure(s)

Overall Residual Risk is acceptable.

Complete Risk Management Report

Risk

reduceable by

inherently safe

design?Risk reduceable by

protective measures in the

device or mfg process?

Risk reduceable by

Information for Safety?

Yes

Yes

Risk reduceable by

restriction of

Intended Use?

Restrict the

Intended Use

(Project Strategy)

Yes

Is further risk

reduction

possible?

Risk Management

Board

No

Yes

Is the

Overall Residual Risk

Acceptable?

Is

re-assessment of risk

necessary?

Ris

k C

on

tro

lO

ve

rall R

es

idu

al R

isk

Ev

alu

ati

on

5

Pro

du

cti

on

an

d

Po

st-

Pro

du

cti

on

Mo

nit

ori

ng

Yes

1

Yes

Yes

Risk Control

Option Analysis

LAUNCH

3

Consult Risk

Management Board

Do medical

benefits outweigh

Overall Residual

Risk?

No

Yes

No

Yes

No

2

No

No

No

4

2

9.4.1

9.4.1

9.4.1

9.4.1

9.4.1

9.4.1

9.4.1

9.4.3

9.4.6

9.5.1 9.5.2

9.5.4

9.6.1

9.4.7

Verify implementation of all risk control measures

Go to

From

Go to

Go to

Go to

From 9.4.5

9.5.3

1

3 2

5

3

9

1

3 2

5

3

9

DR6

Estimate the residual risk assuming

all (planned/existing and additional)

risk control measures will be

implemented

Do medical benefits

outweigh the individual

residual risk?

No

Risk is

unacceptable.

Abort project.

No

Yes

Identify and communicate

failure criticality information pertaining

to risk control measures

DR9

DR10

Review production and post-production information

No

No

9.4.1

9.4.2

Is RMB approval

required?

No

Yes

Yes

9.4.8

Residual risk is judged acceptable

(pending verification)

Individual residual risks are acceptable

9.5.2

Ensure RMF is

released.

9.4.2

9.4.2

9.4.4

9.5.2

9.5.4

9.6.2

9.6.3

9.4.8

DR79.4.6

9.4.7

1 1

7 2

1

1

8

2

Risk Management Process

Part II

Verify effectiveness of all risk control measures

ORR Evaluation After all risk control measures have been verified, the Overall Residual Risk (ORR) posed by the medical device (i.e., all residual risks documented in the Risk Table and displayed on the Risk Matrix) is evaluated to decide if the ORR is acceptable.

Note: It is possible that the ORR can be considered unacceptable even though the individual residual risks are acceptable. This is particularly true for complex medical devices/systems with a large number of individual risks.

Risk Management

Yes

Is risk control complete?

(Are all hazards accurately

considered?)

Is further individual risk

reduction necessary or

possible?

Are new hazards/hazardous

situations introduced or existing

risks affected due to additional

risk control measures?

No

Document additional risk

control measure(s)

Overall Residual Risk is acceptable.

Complete Risk Management Report

Risk

reduceable by

inherently safe

design?Risk reduceable by

protective measures in the

device or mfg process?

Risk reduceable by

Information for Safety?

Yes

Yes

Risk reduceable by

restriction of

Intended Use?

Restrict the

Intended Use

(Project Strategy)

Yes

Is further risk

reduction

possible?

Risk Management

Board

No

Yes

Is the

Overall Residual Risk

Acceptable?

Is

re-assessment of risk

necessary?

Ris

k C

on

tro

lO

ve

rall R

es

idu

al R

isk

Ev

alu

ati

on

5

Pro

du

cti

on

an

d

Po

st-

Pro

du

cti

on

Mo

nit

ori

ng

Yes

1

Yes

Yes

Risk Control

Option Analysis

LAUNCH

3

Consult Risk

Management Board

Do medical

benefits outweigh

Overall Residual

Risk?

No

Yes

No

Yes

No

2

No

No

No

4

2

9.4.1

9.4.1

9.4.1

9.4.1

9.4.1

9.4.1

9.4.1

9.4.3

9.4.6

9.5.1 9.5.2

9.5.4

9.6.1

9.4.7

Verify implementation of all risk control measures

Go to

From

Go to

Go to

Go to

From 9.4.5

9.5.3

1

3 2

5

3

9

1

3 2

5

3

9

DR6

Estimate the residual risk assuming

all (planned/existing and additional)

risk control measures will be

implemented

Do medical benefits

outweigh the individual

residual risk?

No

Risk is

unacceptable.

Abort project.

No

Yes

Identify and communicate

failure criticality information pertaining

to risk control measures

DR9

DR10

Review production and post-production information

No

No

9.4.1

9.4.2

Is RMB approval

required?

No

Yes

Yes

9.4.8

Residual risk is judged acceptable

(pending verification)

Individual residual risks are acceptable

9.5.2

Ensure RMF is

released.

9.4.2

9.4.2

9.4.4

9.5.2

9.5.4

9.6.2

9.6.3

9.4.8

DR79.4.6

9.4.7

1 1

7 2

1

1

8

2

Risk Management Process

Part II

Verify effectiveness of all risk control measures

ORR Evaluation – Risk Management Board

The Risk Management Board (RMB) must be consulted and must decide about the acceptability of the ORR if any of the following conditions is true:

• Any residual risk is in the High Risk (Red) region,

• Any residual risk in the Medium Risk (Yellow) region has severity S3 or higher, or

• The Risk Management Team requests RMB consultation.

Risk Management

RMB Members The Risk Management Board must include, at a

minimum, the following five functions (roles):

1. Head of RA/QA (or authorized designate*)

2. Head of R&D (or authorized designate*)

3. Risk Management Expert

4. Medical Expert (Clinical Expert)

5. Post-Production Monitoring Expert

Note 1: Where a safety representative or comparable function is required by national law, this person or authorized designate must be a member of the Risk Management Board.

Note 2: *Authorized designates must have equivalent or similar organizational responsibility and/or authority.

Risk Management

– Additional functions (roles) may be added to the Risk Management Board as needed, for example:

• Project Leader

• Technical specialist(s)

• Manufacturing representative(s)

• Marketing representative (for perspective on product use)

• Legal representative (typically only for higher risk products)