process validation for bme 512
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BME 512BME 512Process ValidationProcess Validation
Copyright GCI, Inc. 2006
Process Validation Process Validation RoadmapRoadmap
MVP
OQChallenge
Process PQ
MVR
Risk
IQ
OQ Limit
Product PQ
Copyright GCI, Inc. 2006
Process Validation StepsProcess Validation Steps
1. Determine Risk from FMEA/FTA2. Create a Master Validation Plan3. Perform Installation Qualification4. Identify Acceptable Defect Rate5. Select Reduced Sampling Plan for OQ6. Perform Operational Qualification7. Select Optimal Sampling Plan for PQ8. Execute Performance Qualifications9. Assure Appropriateness of Sampling
Plan 10. Generate a Master Validation Report
Copyright GCI, Inc. 2006
Step 1: Determine RiskStep 1: Determine Risk(from process FMEA)(from process FMEA)
RPN Validation Action
1 - 5 Verification
6 - 10 Moderate LTPD
11 - 15 Minimal LTPD
16 Needs Improvement
Copyright GCI, Inc. 2006
Step 2: MVPStep 2: MVP
Process Rationale
IQ OQProcess PQ
Product PQ Software
Weld Required Required Required Required RequiredAll elements will be performed
Bond Required Required Required RequiredNot Required
Software validation not required because there is no software associated with this bonding process
Seal Required Complete Required Required Required
OQ from similar impulse sealer will be leveraged, see report # 12345 rev B
Requirement
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Step 3: Perform IQStep 3: Perform IQ
Verify Proper Installation
Verify Proper Operation
Verify Equipment Controls
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Equipment IssuesEquipment Issues
Mobile and Non-Mobile Equipment
Multiple Machines
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IQ Validation ToolsIQ Validation Tools
Poka-yokeVerification & Challenge Factory Acceptance Testing
Control PlanProcess FMEA
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IQ DocumentationIQ Documentation
IQ Protocol IQ ChecklistIQ ReportControl PlanFunctional SpecsUser Specs
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Step 4: Determine Acceptable Step 4: Determine Acceptable Defect RateDefect Rate
Based on clinical risk
FDA mandates
SOP documentation
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Step 5: Select a Reduced Step 5: Select a Reduced Sampling Plan for OQSampling Plan for OQ
Why a reduced plan is acceptable at this point
What is a reasonable sample size?
SOP documentation
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Step 6: Perform OQStep 6: Perform OQ
Characterize the process
Establish controls on inputs to ensure quality of output
Alert and action limits
Test the limits
Ensure control plan is effective
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Characterize the ProcessCharacterize the Process
Test Method Validation Use experimental design to identify
key process inputs Determine relationships among
inputs (interactions) Understand relationship between
inputs and outputs Establish controls to ensure stability
and capability
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Challenge vs. Limit TestingChallenge vs. Limit Testing
Challenge Testing results in product that may not meet acceptance criteria
Limit Testing results in product that meets acceptance criteria, but just barely
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Spotlight on OQ:Spotlight on OQ:Taguchi Designed ExperimentTaguchi Designed Experiment Factor Level Response Trial Combined Effect Interaction Confounding
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OQ: Taguchi TechniqueOQ: Taguchi Technique
State the problem State desired results Determine quality characteristics Determine measurement methods Select factors Identify noise and control factors Select orthogonal array
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Taguchi Technique, cont’d.Taguchi Technique, cont’d.
Select levels for factors Select interactions Design the matrix (assign F/L to
columns) Conduct trials Analyze and interpret results Confirm experiment
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Limit Testing In OQLimit Testing In OQ
Using challenge test results, set limits for acceptable product
Poke-yokeManufacturing proceduresOperator trainingCpkReduced sample size is OK
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Regulatory Regulatory ExpectationsExpectations
21 CFR Part 820.75(b) : Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.
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FDA Warning LetterFDA Warning Letter
“You have not demonstrated that the process parameters used, under worst case conditions, assure all the products that you manufacture meet specifications and are appropriate for their intended use…”
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Contents of an OQ ProtocolContents of an OQ Protocol
Purpose/Scope
Reference Documents
Process Inputs
Process Outputs & Specifications
Process Parameters for Each Run
Operator Training Requirements
Procedure for Conducting Validation
Copyright GCI, Inc. 2006
Step 7: Select an Optimal Step 7: Select an Optimal Sampling Plan for PQSampling Plan for PQ
Balancing AQL and LTPD
What is a reasonable sample size?
SOP documentation
Copyright GCI, Inc. 2006
Step 8: Process and Product Step 8: Process and Product Performance QualificationsPerformance Qualifications
Process PQ (Performance Qualification) Demonstrate that product meets acceptance criteria Determine Ppk / Pp Minimum of three lots Nominal process settings Performance Levels tied to Process FMEA
Product PQ (Performance Qualification) Demonstrate that entire manufacturing process
produces product that meets product specification Minimum of three lots Nominal process settings Performance Levels tied to Design FMEA
Copyright GCI, Inc. 2006
Stability and Stability and CapabilityCapability
Stable: Consistently dependable; resistant to change of position or condition; not easily moved or disturbed (American Heritage Dictionary)
Capable: Having capacity or ability; efficient and able; implies that output of process meets requirements (American Heritage Dictionary)
Copyright GCI, Inc. 2006
What are Cpk and What are Cpk and Ppk?Ppk?
Cpk: capability of the process at a point in time (present)
Ppk: capability of the process over time (future)
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How Many Lots?How Many Lots?
Should represent multiple:SetupsRaw materialsEquipmentShiftsOperatorsTooling
Make samples representative of future production
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Process PQ ProtocolProcess PQ Protocol
Purpose/Scope
Reference Documents
Process Inputs
Process Outputs & Specifications
Process Parameters For Each Run
Operator Training Requirements
Procedure for Conducting Validation
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Product PQ ProtocolProduct PQ Protocol
Purpose/Scope Reference Documents Models/Units Product Characteristics Manufacturing Variability Test Method Sample Size Acceptance Criteria
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FDA Warning LetterFDA Warning Letter
“The process validation report does not document that the welding process itself results in a consistent, predictable weld based upon specific operational process parameters. The process validation protocol is inadequate in that it does not specify:
all data to be collected; test procedures to be used to measure
predetermined success criteria; or statistical rationale for the number of devices
per lot or number of lots…”
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PQ ReportPQ Report Cover Page Reference Documents Deviations to Protocol Results
Data summary; Non-conformances & Investigation Results; Errors & how addressed
Additional Process Controls/Monitoring Conclusions
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FDA Warning LetterFDA Warning Letter
Records documenting the procedure show inconsistencies from the protocol. The protocol stated that the validation would make use of three lots of finished devices. However, the summary page indicates that four lots were used to complete testing. Documentation is inadequate to indicate which lots were used for validation and testing or a rationale for why an additional lot was tested.
Copyright GCI, Inc. 2006
Step 9: Verify Step 9: Verify Appropriateness of Sampling Appropriateness of Sampling
PlanPlanAttribute vs. Variable
Distribution Fitting
Distribution-Free
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Step 10: Generate a Master Step 10: Generate a Master Validation ReportValidation Report
Cover Page
Deviations to Plan
Conclusions
MVR Matrix
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MVR MatrixMVR Matrix
Process Comments
IQ OQ Process PQProduct PQ Software
Weld 2345 rev A 1234 rev A 3456 rev A 4567 rev A S-789 n/a
Bond 5678 rev A 6789 rev A 789 rev A 8910 rev ANot Required
Software validation not required because there is no software associated with this bonding process
Seal 9101 rev B XYZ report 1011 rev B 1112 rev A 1213 rev A
OQ from similar impulse sealer was leveraged, see report # XYZ
Validations Completed
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