·Gerd Dautel, 29. September 2011

Vom Modell zur RealitätVom Modell zur RealitätFrom the Model to RealityFrom the Model to Reality

·BPMN-Modelle im Zentrum eines integrierten Qualitätsmanagementsystems·BPMN Models in the center of an integrated QM system

2

Guidance &Best Practice

Standards

Europe

The Regulatory Environment for The Regulatory Environment for Medical Devices is complex! Medical Devices is complex!

MDD

Laws …MPG

USA

QSR

ROW

Directives &Laws

Laws … Laws …

(China)

Laws …

(Korea)

Laws …

(Japan) Laws …

ISO IEC

Stan-dards

…UL

GHTF

Stan-dards

…

FDA AAMI

Stan-dards

…

…

Adva- Med

AAMI

Guid-ances

…

Guid-ances

…

CorporateRequirements

Policies

Corporate QM System

Local QM Systems

Business Needs

Harmonize, standardize & establish

Establish regulatory requirements

3

Follow QSR & ISO structure.

They are diverse, use different notations, formats, language.

Procedures have unclear interfaces.

The quality system and the business (processes) live in parallel.

And they are :

complex,

burdensome,

confusing,

verbose,

redundant,

inconsistent,

ambiguous, …

Quality Management Systems in the Quality Management Systems in the Medical Device Industry -Medical Device Industry -

4

A business oriented approach.

Regulatory requirements which are understandable and related to daily doing.

Procedures which are easy to find and to understand.

A system which does not become complex and burdensome over time.

A discipline for and a culture of continuous improvement.

What would we need?What would we need?

iQMSiQMS = an = an iintegrated ntegrated QQuality uality MManagement anagement SSystemystem

5

I. Big Picture

II. BP Maps

III. Procedures

IV. Instructions

V. Forms

Quality Planning

Business Planning

ManagementReview

Cust

omer

Regu

lato

ry B

odie

s Compliance Control

Regulatory Requirements

Corporate Requirements

IMT Processes

Continuous Improvement

Establishes iQMS

TrendsReports

OperativeGoals

StrategicGoals

MarketNeeds

Regulatory Requirements

Concept Development

Concept ProductDesign

Small SeriesProduction

DMR

Innovation Process

Risk Management

Human Factors Engineering

Reliability Engineering

Hazards Hazards Architecture & Design

Mitigation Measures

Specs

Reliability Measures

HI Design

Mitigation Measures

Regulatory Processes

RM Report (Risk vs. Benefit)

Specs

Assurance Case Creation

Remaining Critical Risks

Evidence

Cad

aver

Lab

Pro

cess

La

b P

lan

ne

rL

ab

Me

tho

ds

E

ng

ine

er

La

b C

oo

rdin

ato

rL

ab

Ob

se

rve

rH

CP

IMT

A

rch

ite

ctu

ral

Bo

ard

Define Cadaver Lab Expectations

PlanCadaver

Lab

OrganizeCadaver

Lab

Develop Assessment Methodology

and Procedure

PrepareCadaver Lab

Execution

Brief HCP

Debrief HCP

PerformSurgery

ObserveSurgery

PerformLab Team meeting

Consolidate Cadaver Lab

Results

All surgeries done

Lab Plan

Procedure Protocol

Lab Assess-

ment Metho-dology

Lab Agenda

Forms for protocols and notes

Consolidated Lab Results

Lab Team Summary

HCP Debriefing Protocol

Observer Notes

HCP Briefing Protocol

More Surgeriesto perform

Assess Cadaver Lab Results and decide

on next steps

Lab Assessment

Results

Clinical, Regulatory and Professional Affairs

Need for HCPs and Consultants

Selected HCPsand Consultants

Plans for HCPsand Consultants

HCP / Consultant Protocols(Completion Report)

Concept Development Finished

3.1 Research 3.2 Inception 3.3 Evaluation

Perform Technology Scouting /

Assessment / Acquisition

Perform Business Research

Define Technology Platform

Draft Application Plattform

DevelopMarket Concept

DevelopTechnical Concept

Plannext Generation

Plan Iteration

Check Market Product Feasibility

Check Indication Feasibility

Perform Requirements

elicitation & analysis

Decision:- Ok: Start Inception Phase- Revise: Rework Research- Stop: Terminate Concept Development

Decision:- Ok: Start Evaluation Phase- Revise: Rework Inception- Revise Technology: Rework Research- Stop: Terminate Concept Development

Decision:- Ok: Finish Concept Development- Revise: Rework Transition

Decision:- Ok: Start Transition to Product Development- Further investigations necessary : plan and evaluate next Generation, go to Inception- Revise Technology: Rework Research- Stop: Terminate Concept Development

Some issues still open

All open issues of Generation n evaluated

Approve Generation candidate for Transition

with all stakeholders

Evaluate open issues

Complete and hand over Transition

Tangibles

3.4 Transition

LEVEL PURPOSEDepicts all IMT business processes

IMT‘s business prosseses refined down to procedures

Detailes procedural workflows and its associated requirements

Provide detailed task instructions, depict methods or education material

Checklists, forms, templates

iQMS architecture

Balanced documents

with consistent Interfaces

Business oriented process design

Establishes regulatory

and business requirements

Stry

ker I

MT

Cust

omer

Concept Development

Needs

Cust

omer

Regu

lato

ry B

odie

s

ProductDesign

ProductionDMR

Safety & Effectiveness

Controls

Continuous Improvement

Management Processes

Supporting Processes

NC

Rese

arch

Innovation Process

Regulatory Compliance

Core Processes

IMT Processes

Product

Complaints

iQMS is constructed using BPMNiQMS is constructed using BPMN

Strategy

6

Level I – The Big PictureLevel I – The Big Picture

Characteristics

Uses BPMN in a very loose manner.

Identifies all top level business processes.

Shows major interrelationships.

Stry

ker I

MT

Cust

omer

Concept Development

Concept Specs

Cust

omer

Regu

lato

ry B

odie

s

ProductDesign

ProductionDMR

Safety & Effectiveness

Controls

Continuous Improvement

Management Processes

Supporting Processes

NC

Rese

arch

Innovation Process

Regulatory Compliance

Core Processes

IMT Processes

Product

Complaints

7

Level II – Business Process MapsLevel II – Business Process Maps

Characteristics

Use BPMN in a very simplistic manner.

Maps tell a “story” (the inner logic of a business process).

They are refined down to the level of procedures.

Help to find procedures quickly.

Are “design specs” for procedures.

Help to balance procedures.

Ensure consistent interfaces.

Helps to avoid silos.

Concept Development

ConceptSpecification

ProductDesign Production

DMR

Innovation Process

RiskManagement

Human Factors Engineering

Reliability Engineering

Architecture & Design

Mitigation Measures

Specs

Reliability Measures

HI Design

Mitigation Measures

Regulatory Compliance

RM Report (Risk vs. Benefit)

Safety & Effectiveness Controls

Specs

Assurance Case Creation

Remaining Critical Risks

Evidence

Mitigation Measures

Causes(for potential hazards)

Mitigation Measures

Hazards

8

Level III – ProceduresLevel III – Procedures

Characteristics

Use BPMN in a correct, descriptive manner.

Procedures start with their task flow description.

The task flow structures the procedure.

Integrate regulatory and business requirements on a task level.

Define the cooperation between different roles.

Have consistent interfaces.

Concept Development Finished

Start Concept Development

3.1 Research 3.2 Inception 3.3 Evaluation

Perform Technology Scouting /

Assessment / Acquisition

Perform Business Research

Define Technology Platform

Draft Application Plattform

DevelopMarket Concept

DevelopTechnical Concept

Plannext Generation

Plan Iteration

Check Market Product Feasibility

Check Indication Feasibility

Perform Requirements

elicitation & analysis

Decision:- Ok: Start Inception Phase- Revise: Rework Research- Stop: Terminate Concept Development

Decision:- Ok: Start Evaluation Phase- Revise: Rework Inception- Revise Technology: Rework Research- Stop: Terminate Concept Development

Decision:- Ok: Finish Concept Development- Revise: Rework Transition

Decision:- Ok: Start Transition to Product Development- Further investigations necessary: plan and evaluate next Generation, go to Inception- Revise Technology: Rework Research- Stop: Terminate Concept Development

Some hypotheses still open

All hypotheses of Generation n evaluated

Approve Generation candidate for Transition

with all stakeholders

Complete and hand over Transition

Tangibles

3.4 Transition

Specs

Concept Development

Specs

9

Level IV – InstructionsLevel IV – Instructions

Co

nce

pt

Dev

elo

pm

ent

Pro

du

ct D

esig

n

Approve Generation Candidate for

Transition with all Stakeholders

Evaluation Tangibles

Draft Transition Tangibles

Approval Protocol

Complete and hand over Transition Tangibles

Create Design Inputs for DR1

Prepare Inputs for DR2

Prepare Inputs for DR3

Prepare Inputs for DR4

Dra

ft D

ocum

ents

,S

uppo

rtin

g D

ocum

ents

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roto

type

s

Sta

rt P

rodu

ct D

esig

n

Dra

ft D

ocum

ents

,S

uppo

rtin

g D

ocum

ents

,P

roto

type

sChecklist for Approval

Req

uire

men

ts fo

r D

R1

Dra

ft D

ocum

ents

,S

uppo

rtin

g D

ocum

ents

,P

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type

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Dra

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ocum

ents

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uppo

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ocum

ents

,P

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type

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Req

uire

men

ts fo

r D

R3

Req

uire

men

ts fo

r D

R2

Req

uire

men

ts fo

r D

R4

Check Milestone „Design Concept

Selection“

Go to Execution

PhaseDesign & Development Planning Phase

Transition Phase

DR1Design Input

& Performance

req’s

DR2Hazard

Identification

DR3Concept Review

DR4Risk and Design

Capability Assessment

Transition (to Product Design)

Characteristics

Instructions (and training material) use BPMN in a detailed manner.

BPMN workflows may be supplemented by any helpful icons or notations.

Provide detailed directions and requirements for a specific task.

Keep interfaces consistent.

10

Define Intended Use

SpecifyUser Needs

Review CAPA, Complaints and Issue Tracking

Databases

Specify System Requirements & Acceptance Criteria

Design Input ProcessUsability Engineering Process

EstablishTraceability Links

Usability Engineering

Input

Voice of theCustomer

Design Input

Regulatory Affairs Assessment

Risk Management Process

Risk Control Measures

Standards and Regulations

Norm Control

Create Design Input

Level IV – MethodsLevel IV – MethodsCharacteristics

Use BPMN in a descriptive manner.

Explain the principle, how a certain task shall be performed.

Don’t have the very detailed and prescriptive level of instructions.

Integrate regulatory and business requirements.

Define the cooperation between different roles.

Keep interfaces consistent.

11

P

Design Review

Project Leader Design Review Team

Design Review Meeting (DR N)

Select Design Review

Team

Prepare an Shedule

Design Review Meeting

form(Findings, decision, due date)

Approved Tangibles

form(List of tangibles)

Tangible Review and

Approval

PDM link

Perform Design Review

Review Rules (from a training slide)

Purpose is to confirm that work is complete and accurate.

They are not meant to be a brainstorming session!

Perform them when the work is ready to be reviewed!

Individual reviews may be subdivided or combined as long as all requirements are met.

Additional activities may always be added to the scope of review.

Supported by SOP and form!

Level IV – Training Material Level IV – Training Material

12

ID HW SW EL Task Instructions Tangibles

DESIGN

INPUT

[10] X X

A, B,

C

X Create Design Inputs

Consolidate User Needs and translate them into system

requirements and characteristics.

Consolidate compulsory User Needs and translate them

into compulsory system requirements.

Define interfaces and system boundaries if applicable

Consider open issues of former releases (especially in

case of software)

SOP - Design Input

SOP - Medical Product

Systems and

Combinations

F - Design Input

F - Software

Requirements

Specification

PROJECT

STRATEGY

[11] X X

A, B,

C

X Establish the project strategy including (excerpt):

Intended use definition

Project goals, objectives and members

Project risks

Patent potentials and issues

Marketing issues

Rough forecast(pilot run,1st,2nd, 3rd quarter)

Establish regulatory strategy including:

Classification

Submission strategy

None F - Project Strategy

Plan

F - Regulatory Affairs

Assessment

Procedures call Instructions Procedures call Instructions

(Excerpt from Product Design procedure)

13

Structures iQMS in a Business Process Hierarchy using BPMN.

Is a skeleton for future growth of the system.

The “Business Process Modeling and Notation” is our standard business process description language.

The “Information Mapping” method structures procedures and instructions for readability.

About how to express requirements simple and clear.

Procedures are the cradle of roles.

A unique definition of roles is important.

Interfaces need to be understood and properly modeled.

Further standardization, automation and effectiveness and efficiency measures.

Constructs & Modeling methods

Important iQMS building blocksImportant iQMS building blocks

14 Source: Prof. Dr. Allweyer, University of Applied Sciences Kaiserslautern

Status & OutlookStatus & Outlook

Value Chains, Value Networks

Business Processes, Procedures, Events

Products and Services

Goals, Objectives, KPIs, Metrics

OrganizationalStructure, Roles

Risks andControls

!Business Rules

§

Requirements, Standards, Regulations

BusinessObjects, Data,Documents

PhysicalResources(Machinery,Equipment)

IT Systems

?

?

?

?? ?

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Lessons learnedLessons learned

BPMN is very valuable for creating a business process hierarchy! All levels are “a unified whole”;

Rules or patterns for top down design would help;

All requirements (regulatory & business) are integrated, which makes them manageable.

BPMN supports a common “look & feel” across business process levels, procedures and specifications.

Used in procedures, instructions, training material, design specs, manufacturing specs, etc.;

BPMN rule set and patterns to be developed internally;

BPMN needs to be supplemented by documentation structure and writing rules.

16

Lessons learned, ctd.Lessons learned, ctd.

Keep a BPMN based business process & QM system balanced and consistent. Establish on top levels clear and simple interfaces, and refine those on lower levels;

Maps tell a story (the inner purpose of a business process);

Consider the rule of thumb for avoiding complexity ( 7+/- 2 elements / process map);

Keep process and task flow depictions clear and harmonic (e.g. aligned at grid);

Define the purpose of processes & procedures;

Define interfaces;

Procedures should have about the same length;

Establish a lectorate.