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Validation
• Requirement:
“establish documented evidence which provides a high degree of assurance
that a specific process will consistently produce a product meeting its
predetermined specifications and quality attributes.” [1]QSR 820.3](https://image.slidesharecdn.com/validationmasterplanning2-141103091702-conversion-gate01/75/Process-Validation-Master-Planning-DMAIC-Fusion-7-2048.jpg)
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Process Validation Master Planning DMAIC Fusion
ARV Excellence is a consulting firm specializing in process validation for medical devices, focusing on regulatory compliance, risk management, and process improvement. The document outlines the validation lifecycle, including risk management strategies based on ISO 14971, as well as the importance of a Master Validation Plan (MVP) to ensure reliable processes. It emphasizes the need for evidence-based documentation to assure consistent product quality and regulatory adherence.
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Process Validation Master Planning DMAIC Fusion
- 1. Process Validation MasterPlanning Medical Device Lean Sigma ARV Excellence is a consulting firm based in Galway Ireland. ARV Excellence. Better results. Assured.
- 2. www.arvexcellence.com Background ARVExcellence: expertise in medical device, pharma and drug/device combination product process improvement
- 3. www.arvexcellence.com Validation: RiskManagement Verification • Why Validate – Patient Safety – Regulatory Requirement – Business Sense
- 4. www.arvexcellence.com Process ValidationPlanning • Risk Management Plan – ISO 14971 Section 3.4/ Annex F – Contents • Manage the risks – Identify and control KIPV • Verification of risk control measures – By Validation (A.2.6.3) • Document MVP and MVR – Validation activities – Verification activities
- 5. www.arvexcellence.com ISO 14971Risk management plan 3.4 Risk management plan This plan shall include ……….: a) the scope – product, process realisation lifecycle b) assignment of responsibilities and authorities…; c) requirements for review of activities….; d) criteria for risk acceptability….; e) verification activities…….; f) activities related to collection and review of relevant production and post-production information. EN ISO 14971:2007 (Detail in Annex F)
- 6. www.arvexcellence.com Validation LifeCycle Product FMEA IQ OQ PQ Change Assessment Revalidation Design Development Process Map Process FMEA Attribute Test Method Qualification Variable Test Method Qualification Master Validation Report Master Validation Plan Process Monitoring Process Control Development Commercialisation
- 7. www.arvexcellence.com Validation •Requirement: “establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” [1]QSR 820.3
- 8. www.arvexcellence.com Risk –both look the same Risk
- 9. www.arvexcellence.com Validation -Document this:
- 10. www.arvexcellence.com Process Description: Process MAP/ Process Flow Chart • Process understanding and overview • Description of the process • Logical sequence of steps Assemble Xxxxx-00 Mould xxxxx-01 Trim and Inspect xxxxx-01 Pack & Blister Seal xxxxxx-01
- 11. www.arvexcellence.com Source ofInformation FMEA Failure Mode and Effects Analysis Product/ Process Potential Failure Mode Effect from Failure Cause of Failure OCC SE V CI Det SOD Proposed Corrective Action Pack No seal Non sterile Sealing temperature too low 2 -- -- -- Sealing temperature too high Risk - CI = Severity x Occurrence; Determines Criticality Index
- 12. www.arvexcellence.com Confidence andReliability Example: Quantify Risk Data Type Confidence FMEA Risk Index Level Minimum Levels Defective Reliability Variable 95% II - FDA Mandated 0.1% 99.9% II 0.3% 99.7% I 5% 95% 0 Attribute 90% (10th percentile) II 1% 99% I 3% 97% 0 Limit/ Challenge 90% (10th percentile) II 10% 90% I 20% 80% 0
- 13. www.arvexcellence.com Goal: Targetand Spread: Confidence and Reliability Accuracy = On target Precision = Spread Specification Reduce spread Risk Risk Specification Centre on target Off centre and spread = process variation = risk.
- 14. www.arvexcellence.com Sources ofVariation Sources of variation > Curves in time > Eoin Barry Methods Measurement systems Machines Materials Process Observed variation performance IQ MSV OQ PQ
- 15. www.arvexcellence.com Business Case:Old Patterns Assemble Inspect Weld Inspect Linish Inspect Polish Scrap Inspect Disassemble Rework Waste Costly rework and inspection activities; Documentation; CAPA; MRB Risk;
- 16. www.arvexcellence.com Business Benefits Reliable processes Assemble Inspect Weld Inspect Linish Inspect Polish Waste eliminated: Resources free to resolve other issues; Less risk £ / € / $ Saving
- 17. www.arvexcellence.com Begin withthe end in mind…
- 18. www.arvexcellence.com Blister Sealer Assurance Consistently 95% confident that 99.9% of the blister seal pack are have a seal strength between 1.5 and 2.5 lbs X-bar +/- k s Predetermined BS ISO 16269-6 Determination of statistical tolerance intervals
- 19. www.arvexcellence.com n: SampleSize Planning (Time and cost) • Statistical validity – minimum n to test Normality • Wider Interval – Less likely to fit in specification • Width of Tolerance Interval – X-bar +/- ks k = f(n, assurance, proportion) – Lower n , wider interval – Higher Risk Index, greater proportion, wider interval BS 2846-7 Tests for departure from normality
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- 21. www.arvexcellence.com Validation MasterPlan Document • Defines the Scope of the validation effort – Communication – Planning tool • Quality Document: Available for inspection • Overview of the GMP compliant approach • Living Document – Process Improvement – CAPA
- 22. www.arvexcellence.com MVP Tableof Contents & Reference Documents Why validation is required. TOC • Responsibilities and Review • Introduction • Purpose • Scope • Revision History • Reference Documents • Process Description • Master Validation Plan Matrix • Product Performance Qualification • Appendices Reference Docs • Validation Policy Document • Process Validation SOP • Product Specifications • Process Flow Chart • Component Specifications • Control Plan • Product Risk Analysis Workbook • Process FMEA • Training Process & Products covered: Phase Contents and Ref Doc’s meet the requirements of ISO 14971 Section 3.4 & Annex F (Detail)
- 23. www.arvexcellence.com MVP Matrix Line # Process Name & Number Validation Scope KEY: R – Required, L– Completed (historical data), NR – Not Required Rationale for Leveraging Historical Validations (L) or Elements Not Required (NR) Process IQ Process Verification Process Validation Equipment IQ/OQ Software IQ / OQ Test Method Validation Attribute Test Method Validation Cleaning Validation OQ Limit Performance Qualification (PQ) 1 Blister Seal Xxxx-x1 R N/R L L L R R Cleaning validation completed as per doc xxxxx-xxx ATMV completed as per xxx-xxx TMV completed as per xxx-xxx P/T or GR&R completed OQ required Sealer already installed
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- 25. www.arvexcellence.com Planning forSuccess DMAIC Phase DFSS Define Measure Analyse Improve Control Design x x x 600 500 400 300 200 Process Capability Analysis for Length LSL Target USL USL 602.000 Development 100 Target 600.000 x x x x x x LSL 598.000 Mean 599.548 0 Sample N 100 Process Map x x Risk (FMEA) x x x x Process StDev process (Within) 3 process 4 process 2 process 1 StDev (Overall) Potential (Within) Capability Cp CPU CPL Cpk Cpm 0.576429 0.620865 1.16 1.42 0.90 0.90 0.87 trial IQ Overall Capability Observed Performance Exp. "Within" Performance Exp. x "Overall" Performance x x x Pp 1.07 % < LSL 1.00 % < LSL 0.36 % < LSL 0.63 PPU 1.32 % > USL 0.00 % > USL 0.00 % > USL 0.00 PPL 0.83 OQ x x x x x Postal applications are dealt with too slowly when returned to branch. PQ x Surface Plot of Conversion x x Method Validation D New or existing e property x l i v e a r Control x x b e l Monitoring x x Change x x x x x x Revalidation x x x x x x RPN 186 155 127 106 Percent 32.4 27.0 22.1 18.5 Cum % 32.4 59.4 81.5 100.0 100 80 60 40 20 0 RPN Percent Example Pareto 598 599 600 601 602 % Total % Total % Total Ppk 0.64 0.36 1.00 0.83 Process Data Within Overall lab production -42.55 -42.60 -42.65 -42.70 lab production 70 lab production 1 CMM p o s it io n Y 2 3 123 Multi-Vari Chart for positionY by trial - part Panel variable: part Application Time Information Requirements Method 69 Knowledge IT Systems The time from when a customer first submits an application to when all necessary information to fully process the application is on the bank's information system or relevant file Customer does not provide necessary information on time What information is required? What method is used to supply it? Application via internet or via branch is faster than postal application Where and when does it originate? How many applications are received for each method? What information must be supplied manually? Is there data on speed of application for each method? Customer is not sure what type of mortgage he/she needs. Bank staff unable to provide advise due to lack of knowledge Internet site is too slow or down What is too slow? How often is the site down? Customer has difficulty understanding infromation requirements. 10 +/- 5 days Type of Mortgage 60 68 67 66 65 64 62 61 55 Time 160 63 165 50 Conversion Temp 170 1 4 7 10 13 16 19 22 25 28 15.0 12.5 10.0 7.5 5.0 Obser v at ion I ndividual Value UCL= 14.36 _ X= 10.10 LCL= 5.83 1 4 7 10 13 16 19 22 25 28 8 6 4 2 0 Obser v at ion Moving Range UCL= 5.235 __ MR= 1.602 LCL= 0 1 1 1 I -MR Char t of Temp
- 26. www.arvexcellence.com Master ValidationReport Matrix Process Name & Number Validation Scope Process Verification Process Validation Process IQ Equip ment IQ/OQ Software IQ / OQ Test Method Validation Attribute Test Method Validation Cleaning Validation OQ Limit Performance Qualification (PQ) 0x xxx-xx Protocol Prot Rept Prot Rept Prot Rept Xxx-xx Xxx-xx- 1 Prot Rept 0x xxxx-2 Report Document the protocol and report and conclusion: Process is validated for its intended use
- 27. www.arvexcellence.com Summary •MVP Risk management plan ISO 14971 • Validation is verification of risk control measures – Patient – Regulatory – Business • Risk – Variation – Variation reduction strategy • Business case • Report Help is available
- 28. Call us www.arvexcellence.com www.MedicalDeviceLeanSigma.com +353 (0)91 423 873 Eoin@arvexcellence.com
Editor's Notes
- #3 Eoin and Mike