· gerd dautel, 29. september 2011 vom modell zur realität from the model to reality ·...
TRANSCRIPT
·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
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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 -
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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
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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
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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
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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
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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
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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
,P
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
roto
type
s
Dra
ft D
ocum
ents
,S
uppo
rtin
g D
ocum
ents
,P
roto
type
s
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.
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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.
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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
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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)
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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.
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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.