Building a Cradle-to-Grave Approach with Your Design Documentation and Data Denise D. Dion, EduQuest, Inc. and Gina To, Breathe Technologies, Inc.

Building a Cradle-to-Grave Approach with Your Design Documentation and Data

Denise D. Dion, EduQuest, Inc.

and

Gina To, Breathe Technologies, Inc.

© 2007 EduQuest, Inc.

Agenda

• The Yin/Yang of Design and CAPA: Cradle to Grave

• Using Design Transfer to Set Up Your CAPA System

• Risk Management Transcends Design

• Case Studies


The Yin/Yang of Design and CAPA:Cradle-to-Grave


Cradle-to-Grave Concept of Design

Design Controls

CAPA

Product Monitoring

Complaints

Risk Management

Audits

Service Reports


Design Input


Design Inputs - Sources

• Human Factors• Regulations• Standards• Guidance• Preliminary Risk Assessment activities• Failure Investigations of Complaints, MDRs, CAPAs,

Recalls • Marketing and Clinical studies and surveys


Requirements to Top-Level Specifications

• Traceability– Traceability from requirements to specifications to design

verification and validation tests and test results is essential for good failure investigations

– Traceability should be started during design input and updated as the design progress through remaining phases

– Traceability should include Requirements, Specifications and Hazard Mitigations


Design Outputs


Design Output - 21 CFR 820.30(d)

• Procedures must …– ensure the identification of outputs essential for

proper safety and functioning of the device


Essential Outputs

• Use essential outputs to identify when a Failure Investigation is needed for a given complaint, in-coming, in-process or finished product failure

• Changes to these should be done with input by design engineers

• CAPA issues with essential outputs lead to either big improvements to design or process or to introduction of unintended consequences


Design Verification/Validation


Verification/Validation and CAPA

• The results of verification and validation tests should be available for use to address issues raised via the CAPA system

• Traceability from requirements to specifications to verification tests and test results are helpful in identifying true design flaws versus misuse or identification of an unknown failure mode


Design Change


Design Change Control

• Changes made to correct or compensate for faults found during any testing should follow the same procedures and controls as for any other change

• This data should be made readily available for assessing CAPA issues


Changes - Tasks

• Problem identification, evaluation and resolution tracking

• Proposed change assessment

– Does the change affect or may it affect design?

• Determine impact to appropriate documents (e.g., Requirements, Preliminary Risk Assessment, FMEA, etc.)

• Documentation update


Changes - Tasks

• Regression analysis or impact assessment and testing to determine change impact to the whole design

• Testing to evaluate correctness of the implemented change(s)

• Re-verification and re-validation of the device or device components after changes are implemented


Change Control Policy after Design

• Device Change Control – Assessment of Changes– Changes will be assessed to determine the extent of

validation or verification requirements

– All changes shall be documented, controlled and where applicable be linked or referenced in the Design History File


Design History File


Design History File

• Tells the story of a device or device family’s development from beginning to end

• The DHF contains the documentation necessary to assure changes to design or process for manufacture of the device do not adversely impact the device design and lead to improvement in design and process


Design History File

• Becomes a mixture of living documentation and historical records

• Living documents for the device family …– Describe the current state of the device – Examples are requirements, specifications, risk,

documentation and traceability. – Updated in whole when a change occurs (i.e. new

revision)


Using Design Transfer to Set Up Your CAPA System


Design Transfer Method

• Transfer Planning Begins Early in the Design Process

• The Process Must be Designed (or Re-Designed) with the Design of the Device


Design Transfer Documents

• Process FMEA Report

• Process Design of Experiments

• Process Validation Protocol

• Process Validation Test Report


Design Transfer Method

• Process Flow• Process Map• Production Line Set-Up (with space, equipment and

location defined)• Process Hazard Analysis• Process FMEA

– Review and Conformance to Design FMEA


Design Transfer: Risk

• Manufacturability is part of design

• Process risk needs to include mitigations relative to product risk

• Product risk documentation is needed to assure process is adequate for design


Design Transfer: Essential Elements

• Product Risk documentation shows what failure modes, components, parts, etc. should be monitored and trended.

• Identification of essential elements further identifies what needs to be monitored and trended

• Design and Process Validations indicate critical control points for manufacturing and design


Risk Management Transcends Design


Risk analysis•Intended use and identification of characteristics related to the safety of the medical device•Identification of hazards•Estimation of the risk(s) for each hazardous situation

Risk evaluation

Risk control•Risk control option analysis•Implementation of risk control measure(s)•Residual risk evaluation•Risk/benefit analysis•Risks arising from risk control measures•Completeness of risk control

Riskassessment

Evaluation of overall residual risk acceptability

Risk management report

Production and post-production information

Riskmanagement

Risk Process Flow


Risk Management: Requirements

• Preliminary Risk Assessment (top-down risk assessment) should occur while the requirements are being determined.

• High risk requirements should be modified or not included in the initial requirements document.

• FMEA or FTA (bottom-up risk assessment) should be used to further refine requirements or determine specifications.


Risk Management: Change

• Changes to design or process need to be assessed against the original risk documents -– Does the change introduce a new failure mode or

hazard?

– Does the change add a new mitigation to an existing failure mode or hazard?

• Update the risk documents as appropriate


Risk Management: CAPA Trends

• Trends need to be assessed against the original risk documents -– Does the trend support the original risk determinations

for severity, frequency or detectability?

– Does the trend show the original risk determinations were either too severe or too generous?

• Update the risk documents as appropriate


Risk Management: Market Surveillance

• Periodic post-production information review (reference ISO 14971 standard section 9).

• Need to make a routine practice of reviewing MDRs and adverse events from MAUDE database for problems from competitors’ like-products

• New/updated data and risks can be learned from publications, literature reviews, abstracts, presentations, and posters at conferences and congresses


Risk Management: Review

• Allows manufacturers to revisit/review warnings, cautions, contraindications, additional mitigations via labeling, design V&V, production, testing, processes, design.

• The challenge is to have a practical use of risk management, not just a desk/theoretical exercise to show adherence to ISO 14971 (Standard on Medical Devices – Application of Risk Management to Medical Devices).


Case Studies


Case Studies

• Failure modes - found in speaker component used in the devices – were not evaluated as part of new vendor qualification

• Design input requirements from external standards (ISO vs. ASTM) that are conflicting were not addressed

• Risk analysis did not include the potential impact of the production environment conditions on the performance of devices


Questions???


Thank-You

Building a Cradle-to-Grave Approach with Your Design Documentation and Data Denise D. Dion, EduQuest, Inc. and Gina To, Breathe Technologies, Inc.

Documents

device design

design change slide

design documentation

design fmea slide

design outputs

design input slide

design process risk

design testing