A Risk Management System

Founded on Quality Tools

Scott Laman

Teleflex, Inc.

Lehigh Valley ASQ Section March 20, 2014

Teleflex

• Corporate HQ – Limerick, PA

• 12,000 global employees

• In 130 countries

• Class I, II and III devices

• Businesses: Vascular, Respiratory,

Anesthesia, Urology, Dialysis, Surgical,

Cardiac

Typical Medical Kit

Presentation Objectives

• Summarize quality tools used in risk management system development – Provide ideas for how to approach developing

quality system processes

• Describe and link types of product risk analyses – Provide knowledge of typical risk analyses

• Demonstrate the relationship between risk management and statistics

Example of Risk Management

• What is the highest-risk

animal in Pennsylvania?

• How do you evaluate

risk?

Example of Risk Management

Animal Severity Rating Probability Rating

Medical Risk Management Objectives

• Safe and effective products

– Minimize the patient/user risks

• Compliance with internal and external standards

– Minimize the Regulatory risk

• Stay in business so products remain available

– Minimize the business risk

ISO 14971 Risk Management

Risk Management is the systematic application

of management policies, procedures and

practices

to the tasks of

analyzing, evaluating and controlling

(mitigating and monitoring) risk

ISO 14971 Risk Management Process

• Risk Analysis

• Risk Assessment

• Risk Evaluation

• Risk Control

· Intended use and

identification of

characteristics related to

the safety of the medical

device

· Hazard identification

· Risk estimation

Risk analysis

Risk evaluation

· Option analysis

· Implementation

· Residual risk evaluation

· Risk/benefit analysis

· New risks from controls

· Risk control completeness

Risk control

Production and Post-

production information

Evaluation of overall risk

acceptability

Risk management report

· Risk acceptability decisions

Risk

Assessment

Risk

Management

Risk Management System Development

• Process characterization

• Prioritization

• Procedures

• Improvement

• Quality system connections

Process Characterization - SIPOC

Suppliers Inputs Process Outputs Customers Requirements

Step 1:

Plan Risk

Management

Activities

Step 2:

Publish the Risk

Management Plan

Step 3:

Conduct Risk

Analyses

Step 4:

Publish the Risk

Management

Report

Step 5:

Maintain the

Risk

Management File

Regulatory

Agencies

Guidances and

RegulationsRisk Management

File

Regulatory

Agencies Compliance

Product UsersFeedback, complaints,

data for reliability

analysisProducts Patients, physicians,

nurses

High quality, safety,

ease of use, clear

instructions

Management with

Executive

Responsibility

Resources, top-

level vision, key

decisions

Management with

Executive

Responsibility

Customer

satisfaction,

business success

Prioritization: Importance/Urgency

High

Low

HighLow

Importance

Urgency

Procedures – Seeing the Same Way

Procedures: Consensus Chart

Do We Want to

Standardize?

Is There Consensus?

No

Yes

Yes

No

Consensus Chart Strategies

Do We Want to

Standardize?

Hold Meetings to

Work Out

Differences

Everyone Agrees

Anyway

Let There Be

Variation

Proceduralize

Communicate

Train

Is There Consensus?

No

Yes

Yes

No

Consensus

Sta

nd

ard

ize

?

PLAN

DOACT

STUDY

Improvement

Improvement Examples

Improvement Opportunity Corrective Action

Too many procedures, overlap Reduce # of procedures – eliminate

redundancy

Procedures not used Make documents obsolete

Inconsistent usage Proceduralize important issues

Plan/Report not aligned Create templates

Poor documentation practices Reinforce and train

Inadequate training records Update records

Connections – Within RM System

Quality Manual

Risk

Management

Procedure

Risk

Management

Policy

Risk

Management

Report

Template

Health Hazard

Evaluation

Work

Instruction

Risk

Management

Plan Template

Post - market

Surveillance

Hazards

Analysis

Template

Design Failure

Mode and

Effects

Analysis

Template

Process Failure

Mode and

Effects

Analysis

Template

Hazards

Analysis

Design Failure

Mode and

Effects

Analysis

( DFMEA )

Process Failure

Mode and

Effects

Analysis

( PFMEA )

Useability

Failure Mode

and Effects

Analysis

( UFMEA )

Usability

Failure Mode

and Effects

Analysis

Template

Risk Evaluation

Work Instruction

Complaint Risk

Evaluation

Template

Health Hazard

Evaluation

Template

Risk

Assessment

Work

Instruction

Risk

Assessment

Form

Fault Tree

Analysis

Risk Management Process Flow

FTA/Hazard

Analysis

DFMEA/

UFMEAPFMEA

Risk

Management

Report

Risk

Management

Planning

Post-market

Surveillance

New Product

Development

or Product

Changes

Design Plans,

Requirements

Design

Verification

Design

Validation

Product

Release

Design

Concept

Design

Change

Design Control Process Flow

Add Risk Management …

Design Plans,

Requirements

Design

Verification

Design

Validation

Product

Release

Design

Concept

Design

Change

Risk Management

Plan

FTA/Hazards

Analysis

DFMEA/

UFMEA PFMEA

Risk Management

Report

Post Market

Surveillance

Risk Analysis Linkages

• FTA/Hazards Analysis: Use

results from clinician interviews,

field data, engineering

• UFMEA/DFMEA: Use results

from hazards analysis

• PFMEA: Use results from

hazards analysis and DFMEA

The Tree of Potential Harm

Patient Harm

Hazardous

Situation

Reasonable ,

Foreseeable

Misuse

Product Failure

Design

Failure

Process

Failure

Hazards Analysis

• Top-down, most general

• safety driven, focused on patient and user risk

• Considers potential product failure and product

misuse

• Identify potential hazards, estimate severity of

harm and probability of occurrence, evaluate

risks, identify controls, recommend risk reduction

actions

Hazards Analysis Severity Scale

Effect Criteria

Person / Operator / Bystander Rank

Critical Death caused directly by the hazardous situation where the device was a

contributing factor 5

Serious

Serious injury, defined as an injury that is life-threatening or resulting in

permanent impairment of a body function or permanent damage to body

structure

4

Moderate

Serious injury that is not classified as 4, but is defined as requiring

medical intervention to preclude permanent impairment of a body function

or permanent damage to a body structure (temporary)

3

Limited Non-serious injury not involving medical or other third-party intervention,

or moderate discomfort/stress requiring medical intervention 2

Negligible No injury; cosmetic or nuisance only 1

Hazards Analysis Probability Scale

Category Probability of

Occurrence Rank

Frequent > 1 in 10 5

Probable > 1 in 100

< 1 in 10 4

Occasional > 1 in 1000

< 1 in 100 3

Remote > 1 in 10,000

< 1 in 1000 2

Improbable < 1 in 10,000 1

Fault Tree Analysis

• Supplemental tool to HA or FMEAs

• Top-down approach, single failure mode focus

• Analysis diagram utilizing AND and OR gates

(similar to a reliability diagram)

• Often used on highest risk failure modes from an

FMEA

Catheter breaks

during removal

Excessive force

applied to

catheter

Catheter

damaged by user

Catheter

damaged in

package

OR

Weak spot in

catheter

Production quality

problem

AND

QA sample

too small

Extrusion

temperature

inconsistent

2.5%

Improper

removal

technique

OR

Improper

handling of

catheter

Instructions

for use not

clear

Catheter stuck

in patient

Instructions

for use not

clear

Improper

insertion

Doctor not

trained

Incorrect

component

placement

Packing

personnel

not trained

QA not

checking

placement

AND

Lack of

process

control

AND

1.5%

10%

15%

0.7% 0.1% 0.2%

Example Fault Tree Analysis

FMEA

Type Purpose Process

Usability

Systematically looks at the

procedural steps or

instructions for use

Identify use failure modes,

estimate and evaluate risks,

identify controls, recommend

risk reduction actions

Design Considers risk with product

functionality Identify failure modes,

estimate and evaluate risks,

identify controls, recommend

risk reduction actions Process Considers risk with product

manufacturability

Risk Evaluation

Risks can be prioritized using:

• RI (Risk Index) • RI = a combination of S and O

• View in table format

• Ultimately 2 options: AR, UR

• RPN (Risk Priority Number) • RPN = product of S x O x D

• The lower the better

DFMEA

PFMEA

UFMEA

Hazards

Analysis

Risk Acceptability

Hazards Analysis Risk Index Table

Probability of Occurrence

Severity 1 2 3 4 5

5 Medium High High High High

4 Medium Medium Medium High High

3 Low Low Medium Medium High

2 Low Low Low Low Medium

1 Low Low Low Low Medium

Key:

Low Low Risk – Acceptable

Medium Medium Risk – Acceptable

High High Risk – Unacceptable

Example of Combined Risk Analysis

Tissue/Vessel Damage,

Delayed Treatment

Loss of Syringe Device

Functionality

Excessive force during use

leading to separation

Syringe plunger does not fully

depress

Design: Insufficient

tolerance of piston diameter

dimension

Piston Molding:

Excessive mold

pressure

Patient Harm

Hazardous Situation

Usability

Product Failure

Process

Design

Standard Syringe

Syringe Hazards Analysis

Hazard or

Hazardous

Situation

Harm Severity

Rating Cause of Failure

Probability

Rating

Controls to Prevent

or Detect a Cause

Syringe does

not fully

depress

Tissue/ Vessel

Damage,

Delayed

Treatment

5

Improper use

3

Instructions for use,

product labeling

Improper design

tolerances

2

Adequate

requirements, proper

material selection

Improper

manufacturing

4

Manufacturing

process controls,

operator training, final

inspection

Syringe UFMEA

Process

Step

Failure

Mode

Effect on

Procedure/

Patient

Sev.

Rating

Potential

Cause

Prob.

Rating Controls

Prev.

Rating

Syringe

does not

fully

depress

Clinician

Uses

Excessive

Force

Procedural step

needs to be

repeated

Tissue/vessel

damage/delay

of treatment

5

Inadequate

training or

instructions

2

Instructions warn

to not use

excessive force

6

Syringe DFMEA

Item Name

and

Function

Failure

Mode

Effect on

Procedure/

Patient

Sev.

Rating

Potential

Cause

Prob.

Rating Controls

Det.

Ratin

g

Standard

Syringe –

administer

anesthetic

or

medication

Piston

moves with

excessive

resistance

Difficulty

performing

function

Delay of

treatment

7

Inadequate

piston spec

(diameter)

2

Design

verification:

interference fit of

piston to syringe

barrel

Material design:

piston and barrel

material

compatibility

1

Piston is

severely

wedged in

syringe

barrel

Loss of

function

Tissue/vessel

damage

10

Syringe PFMEA

Proces

s Step

Failure

Mode

Effect on

Procedure/

Patient

Sev.

Rating

Potential

Cause

Prob.

Rating Controls

Det.

Rating

Piston

molding

Mold

pressure

too high

Procedural step

needs to be

repeated

Tissue/vessel

damage/delay of

treatment

5

Inadequate

training or

instructions

3

Standard

operating

procedures,

operator training,

in-process and

final inspection

4

Defective

pressure

transducer

2

Supplier controls,

operator

inspection,

preventive

maintenance

3

Statistical Techniques Opportunities

• Design verification and validation

• Process validation

• Post-market clinical follow-up/surveys

• Specific tasks

– Sample size determination

– Acceptance criteria

– Analysis of data

Design V&V Sample Sizes

• Consider the type of data

– Attribute

– Variable

• Use the risk analysis

• Perform statistical analysis

Attribute Data Analysis

• Minimum sample size

– No failures allowed

• Larger sample sizes

– May allow failures

Formula for 0 Failure Sample Sizes

Attribute Testing Sample Sizes

Effect and Criteria Rank Test Strategy

Critical = Death caused directly by the hazardous situation

where the device was a contributing factor 5

Confidence = 95%

Reliability = 95%

N = 59

Serious = Serious injury, defined as an injury that is life-

threatening or resulting in permanent impairment of a body

function or permanent damage to body structure

4

Moderate = Serious injury that is not classified as 4, but is

defined as requiring medical intervention to preclude permanent

impairment of a body function or permanent damage to a body

structure (temporary)

3

Limited = Non-serious injury not involving medical or other third-

party intervention, or moderate discomfort/stress requiring

medical intervention

2

Confidence = 95%

Reliability = 93%

N = 42

Negligible = No injury; cosmetic or nuisance only 1

Confidence = 90%

Reliability = 90%

N = 22

Variable Testing Confidence/Reliability

Effect and Criteria Rank Confidence/Reliability

Critical = Death caused directly by the hazardous situation

where the device was a contributing factor 5

Confidence = 95%

Reliability = 95%

Serious = Serious injury, defined as an injury that is life-

threatening or resulting in permanent impairment of a body

function or permanent damage to body structure

4

Moderate = Serious injury that is not classified as 4, but is

defined as requiring medical intervention to preclude

permanent impairment of a body function or permanent

damage to a body structure (temporary)

3

Limited = Non-serious injury not involving medical or other

third-party intervention, or moderate discomfort/stress

requiring medical intervention

2 Confidence = 95%

Reliability = 93%

Negligible = No injury; cosmetic or nuisance only 1 Confidence = 90%

Reliability = 10%

Variable Testing Confidence and Power

Effect and Criteria Rank Confidence/Power

Critical = Death caused directly by the hazardous situation

where the device was a contributing factor 5

Confidence = 95%

Power = 95%

Serious = Serious injury, defined as an injury that is life-

threatening or resulting in permanent impairment of a body

function or permanent damage to body structure

4

Moderate = Serious injury that is not classified as 4, but is

defined as requiring medical intervention to preclude

permanent impairment of a body function or permanent

damage to a body structure (temporary)

3

Limited = Non-serious injury not involving medical or other

third-party intervention, or moderate discomfort/stress

requiring medical intervention

2

Confidence = 95%

Power = 90%

Negligible = No injury; cosmetic or nuisance only 1 Confidence = 90%

Power = 90%

Variable Testing Difference to Detect

Confidence Level = 95% Confidence Level = 90%

Power of

Test (%)

Difference to Detect, δ (in

terms of std. dev.)

Sample

Size

Difference to Detect, δ (in

terms of std. dev.)

Sample

Size

95

0.1 1302 0.1 1084

0.5 54 0.5 45

0.7 29 0.7 24

1.0 16 1.0 13

1.5 8 1.5 7

90

0.1 1053 0.1 858

0.5 44 0.5 36

0.7 24 0.7 19

1.0 13 1.0 11

1.5 7 1.5 6

Conclusions

• Quality tools and techniques significantly help in risk management system development.

• The risk management system is connected to many other quality system processes.

• Product risk analyses are also interconnected. Different techniques applied together are needed to comprehensively assess risk.

THANK YOU FOR ATTENDING!