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Lessons Learned in Integrating Risk Management and Process Validation. Medical Device Congress Harvard – March 2007 Jim Handzo – Senior Manager QA Innovative Spinal Technologies Fran Akelewicz – Principal Practical Solutions . Agenda.
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Lessons Learned in Integrating Risk Management and Process Validation Medical Device Congress Harvard – March 2007 Jim Handzo – Senior Manager QA Innovative Spinal Technologies Fran Akelewicz – Principal Practical Solutions
Agenda • Optimizing the validation activities sequence using risk management • Determining the statistical approach and acceptance criteria based on risk • Maximizing test plans and resources
Approach • For illustration purposes we will use an example of: • Safety product (functional approach) New feature -a collar with a hinged rectangular plastic guard which will clip over the needle after use to prevent the user from getting stuck with the needle
Key questions for process validation • What are the important design characteristics? • Where and how are they impacted in the process? • What resources do I need? • What do I do first? • How should I conduct the validation? • What do I do if I don’t like the answer?
What are the important design characteristics? • Product inputs to process validation • Key design features • Residual risk profile (dFMEA) • Controls for the risk-prioritized design features
What are the important design characteristics? • Product Inputs (User and Patient) • Key Design Features • Tools • Customer Requirements Matrix • Design Requirements Matrix
What are the important design characteristics? • Product Inputs (User and Patient) • Customer Requirements Matrix • Focused on user needs • Focused on business needs
What are the important design characteristics? • Product Inputs (User and Patient) • Design Requirements Matrix • Focused on risk analysis
What are the important design characteristics? • Product residual risk profile • Without safety feature X
What are the important design characteristics? • Product residual risk profile • With safety feature X
Where and how are key design features impacted in the process? • Process Inputs • Determine process control points that potentially impact the design features • Are process control points • One to one? • One to many? • Many to one? • Determine residual risk impact (pFMEA, FTA, etc.)
Where and how are key design features impacted in the process? • Determine various process points that potentially impact the design feature
Where and how are key design features impacted in the process? • Determine if the control points are • One process point to one design feature • One process point to many design features • Many process points to one design feature
Where and how are key design features impacted in the process? • Use tools to characterize process outputs vs. design features • Design of Experiments (DOE) • Edge of Failure (EOF) Studies • Ranging Studies • Mean Time between Failures (MTBF) • Cpk vs. Ppk • Determine process residual risk • Process Map & pFMEA • FTA • Waterfall with Feedback Loop • EN 60601-1-4 PEMS “V” Diagram
Where and how are key design features impacted in the process? • Process residual risk profile • Changes probability, not severity X
What resources do I need? • Dependent on type of product and/or process being evaluated • Electrical Engineer • Software Engineer • Reliability Engineer • Quality Engineer • Commensurate with the degree of residual risk
What do I do first? • Develop Process Validation Priority Risk Chart • Similar methodology to Product Risk Chart • Process effects on product are rated based on their impact • Safety • Performance • Acceptance • Compliance • Verification • Can also be used to develop a company Validation Master Plan
Process Map • Formation and attachment of needle guard with collar attachment
What do I do first? • Process Validation Priority Risk Chart
What do I do first • Apply to • Entire processes • Sub-processes (then add)
What do I do if I don’t like the answer? • Have a “Plan B” • Identify assignable causes • Justify discounting results with great care • Revisit assumptions made during validation setup • Revisit probabilities assigned to key design features • But you cannot change severity unless you change the design • Define contingencies in acceptance criteria
Determining the statistical approach and acceptance criteria based on risk
Determining acceptance criteria • Document in company policy • Similar to product risk chart • Key elements derived from product risk chart • Severity drives confidence levels • Confidence levels and probability drive sampling plans • Qualitative probabilities (Frequent, Probable, etc.) must be expressed quantitatively • Sampling plans should be discriminating enough to detect defects that relate to high severity/frequently occurring hazards
Determining acceptance criteria • Acceptance Criteria Risk Chart
Sampling plan determination • Determine the operating characteristic (OC) curve of selected sampling plan • Incorporate quantitative probabilities • Determine acceptable errors • Type I (Producer’s Risk) – we say it’s bad when it’s not • Type II (Consumer Risk) – we say it’s good when it’s not • Does it match residual risk and probability?
Sampling plan determination • Determine how much risk (error) you can tolerate in your estimates • Attributes • Percent defective error tolerance • Variables • Error tolerance of the average • Must constantly weigh sample size vs. estimate risk (error) • Economics vs. certainty
Sampling plan determination • Use appropriate probability distributions when determining sampling plans • Binomial • Large populations • Sampling with replacement • Hypergeometric • Small populations • Sampling without replacement
Sampling plan determination • Sampling Calculators available for download at: www.devicecongress.com/agenda/day2.html (Once on the website, go to Track A, 4:10pm session, for links to presentation materials. Calculators are in the excel document.)
Maximizing Test Plans and Resources • Identify resources based on risk • Prioritize the process validation activities based on risk • Choose the acceptance criteria • Choose the appropriate sample methodology to minimize the business risk
Change Control • Once process validation is completed you have established a “state of control” • Any changes made should consider: • Impact to product design risk (design verification testing; design validation testing) • Impact to process design risk (equipment design decisions) • Impact to control of risk within process
Conclusions • Risk management in process validation: • Provides the opportunity to: • challenge existing assumptions • “think out of the box” • Acknowledges the risks that we have taken (product and business) • Provides a common language • Provides a framework for consistency • Formalizes what we have done • Contributes to safer products
Thank You ! Jim Handzo Innovative Spinal Technologies +1 508 452-3517 jhandzo@istspine.com www.istspine.com Fran Akelewicz Practical Solutions +1 215 337-9238 franakelewicz@comcast.net www.practicalsolns.net