CAPA - the importance of data analysis Presented by: Sue Jacobs QMS Consulting, Inc. 1 847 359 4456 sue@qmsconsultant.com QMS Consulting, Inc. 2007 1
Topics Regulatory Requirements Design Controls and CAPA Deciding what data to analyze Responsibilities and frequency Setting action limits QMS Consulting, Inc. 2007 2
FDA & ISO Requirements to Analyze Data QMS Consulting, Inc. 2007 3
Definitions Correction Action taken to eliminate a detected nonconformity Corrective Action Action taken to eliminate the cause of an actual nonconformity or other undesirable situation Preventive Action Action taken to eliminate the cause of a potential nonconformity or other undesirable potential situation A disposition decision repair, rework, scrap Recall, Correction & Removal Corrective action is taken to manage/control recurrence Preventive action is taken to prevent occurrence QMS Consulting, Inc. 2007 4
Corrective Action vs. Preventive Action The data we analyze will distinguish Corrective Action from Preventive Action Corrective Action data source detects actual nonconformity reactive Preventive Action data analysis identifies a potential nonconformity (unfavorable trend) proactive QMS Consulting, Inc. 2007 5
ISO 13485 Requirement 8.5.2 Corrective Action Review nonconformities (including complaints) and their causes 8.5.3 Preventive Action Determine potential nonconformities and their causes QMS Consulting, Inc. 2007 6
FDA Requirement CAPA 820.100(a)(1) Analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned products Identify existing and potential causes of nonconforming product Detect recurring problems QMS Consulting, Inc. 2007 7
21 CFR Part 820 vs. ISO 13485 Requirements Same intent ISO 13485 makes a clear distinction between Corrective Action and Preventive Action 21 CFR Part 820 is more prescriptive in terms of what should be analyzed QMS Consulting, Inc. 2007 8
820.100(a)(1) Analyze Processes and Work Operations Consider what is relevant to your business Type of product Complexity of product Manufacturing process Complexity of the process Monitor data sources relative to the risks associated with failure Product Process Quality System QMS Consulting, Inc. 2007 9
820.100(a)(1) (cont.) Concessions Use-As-Is disposition decisions Deviations (product, process, quality system) Temporary changes It doesn t t meet our requirements but we re using it anyway QMS Consulting, Inc. 2007 10
820.100(a)(1) (cont.) Quality Audit Reports Internal audits and external audits Recurring audit observations Systemic observations Preamble #160: FDA wants to make it clear that corrective and preventive actions, to include the documentation of these activities, which result from internal audits and management reviews are not covered under 820.180(c) QMS Consulting, Inc. 2007 11
820.100(a)(1) (cont.) Quality Records Evidence of compliance to your quality system Training Records Preventive Maintenance Records Environmental Monitoring Records Installation Records Servicing Records Product Returns Change Control Records QMS Consulting, Inc. 2007 12
Warning Letter Example It was revealed that your firm did not establish and maintain procedures for implementing corrective action with regard to certain user complaints of [redacted] failures. Your firm maintained that these types of failures had been investigated before, however the seventeen (17) design changes (DCN's) that were supposed to address the identified failure either did not correct the known failures or had never been implemented. QMS Consulting, Inc. 2007 13
Design Control & CAPA QMS Consulting, Inc. 2007 14
Design Control and CAPA Utilize the output of design control process to drive CAPA Intended use Essential outputs Identification of hazards and estimation of risk (analysis) Risk evaluation (mitigation) Risk control (implemented decision to control risk) QMS Consulting, Inc. 2006 15
Design Control and CAPA Design Control Considerations Product Design Manufacturability of the design Supplier Selection Serviceability Risk Management Risk Evaluation Risk Analysis Risk Control Post Production Design Planning Design Inputs Design Outputs Verification Validation Design Transfer QMS Consulting, Inc. 2007 16
Deciding What Data To Analyze Product Process Quality System QMS Consulting, Inc. 2007 17
CAPA data sources Internal External QMS Consulting, Inc. 2007 18
Internal data sources Acceptance activities (incoming, in-process, final test) Nonconforming product Process controls Environmental monitoring Equipment monitoring Change order/ecn data Design control Internal audits 3rd Party audits Supplier evaluations Management Review Device history records QMS Consulting, Inc. 2007 19
External data sources Complaints MDR s Vigilance Reporting Servicing Warranty Non-warranty Field service reports Product Returns Installation Recalls Legal Claims QMS Consulting, Inc. 2007 20
Product Data Product Process Quality System Monitor data linked to decisions implemented to control risk Controlled Environment Test Methods QC Procedures Equipment Maintenance Supplier Performance Process Monitoring Contract Manufacturer Line Clearance Warning/Cautionary Statements in Labeling Expiration Dating Service Frequency Certified Operators Operator Training Inspection QMS Consulting, Inc. 2007 21
Product Data Enable early detection Production vs. Post Production while product is still within your control QMS Consulting, Inc. 2007 22
Process Data Manufacturing Processes Characterize and evaluate processes Process validation Process controls Equipment Monitoring Automated processes Preventive Maintenance Environmental Monitoring QMS Consulting, Inc. 2007 23
Post Production Data Post Production & Complaint Management Frequency and occurrence as expected Servicing Customer Complaint Adverse Events Returned Products QMS Consulting, Inc. 2007 24
Post Production Data Questions to ask Is this a new or unknown hazard? Has the severity increased decreased? Is the rate of occurrence unexpected? Have the causes of the hazard been confirmed? Are there new causes of the hazard that have inadequate or no mitigation? Is the original risk analysis still valid? Are the risk control measures still appropriate? Update Risk Management plan as more information becomes known QMS Consulting, Inc. 2007 25
Quality System Data Quality Audits Systemic nonconformances Recurring (repeat) nonconformances QMS Consulting, Inc. 2007 26
Who analyzes the data? and when? QMS Consulting, Inc. 2007 27
Define responsibilities QSR requirements mandate that companies have staff with the training, knowledge, and experience for the job Top Managements Role Ensure adequate resources are allocated Process Owners Functional areas should routinely trend the performance of their department and act on the results QMS Consulting, Inc. 2007 28
Define the frequency Data should be examined on a regular basis Define the frequency Use a appropriate statistical methods to analyze and trend data SPC, Pareto Analysis, Control Charts, Scatter Diagrams, Histograms. QMS Consulting, Inc. 2007 29
CAPA Action Limits QMS Consulting, Inc. 2007 30
Setting Action Limits Monitor data directly linked to decisions implemented to reduce (control) risk Design FMEA Process FMEA Hazards and risk mitigation implemented Define criteria (action limits) for CAPA Not all nonconformities require Corrective Action Avoid speeding ticket syndrome QMS Consulting, Inc. 2007 31
Setting Action Limits (cont.) Determine trending points Enable early detection Where would they make the most impact? Establish limits Number of occurrences over time Define Negative Trend For example: A number of consecutive points in an unfavorable direction QMS Consulting, Inc. 2007 32
Setting Action Limits (cont.) Not all CAPAs are created equal Establish a method for prioritization based on risk Prioritize based on severity, significance and risk Significance of the issue will determine the level of investigation Convey the sense of urgency QMS Consulting, Inc. 2007 33
For Example Production and Process Controls Monitor risk control measures Design/Process FMEA Supplier, acceptance activities, line clearance, packaging, labeling, test methods, etc. Establish frequency based on risk Process monitoring (SPC data) Preventive maintenance unplanned or negative trend Environmental monitoring results with a negative trend QMS Consulting, Inc. 2007 34
For Example Complaint Process Product malfunction resulting in death or serious injury (reportable event) Design FMEA Monitor complaint data for Potential failure modes Potential failure effects Negative trend complaints per business quarter QMS Consulting, Inc. 2007 35
For Example Nonconforming Product Recurring nonconformity identified through the review of past nonconformances by Part number, lot number or, work order number Frequency of occurrence as expected? Negative trends Design/Process Product family FMEA Supplier (multiple nonconformances related to the same supplier) Defect code, cause code or reason code QMS Consulting, Inc. 2007 36
Significant issues Utilize multiple sources of data to identify significant issues Acceptance Activities Nonconforming Product Supplier Performance Installation Service Returned Product Process Monitoring Environmental Monitoring Complaints & MDR s Recalls Corrections & Removals Law Suits More QMS Consulting, Inc. 2007 37
Significant issues (cont.) Take a global approach when analyzing quality data to detect recurring problems product, process and quality system Look across business units, divisions, product families Encourage critical thinking QMS Consulting, Inc. 2007 38
Relational Data Identify relationships for multiple data sources Internal Audits & External Audits Audits & Training Records Supplier Performance & Nonconforming Product Final Inspection & Installation Design Changes & Complaints Complaints & Nonconforming Product Preventive Maintenance & Nonconforming Product QMS Consulting, Inc. 2007 39
Warning Letter Example A CAPA report was prepared as a result of several complaints related to holes observed at the hub area of ( ) Needles there is no documentation to demonstrate that potential corrective and preventive actions were discussed and evaluated QMS Consulting, Inc. 2007 40
Warning Letter Example although your firm is aware that "big flares" occur during the insert molding process of the needles causing the holes in the hub defect, you have not identified any corrective and preventive actions to prevent this problem. QMS Consulting, Inc. 2007 41
Initiate CAPA when Action limits are reached Individual high risk failure meet predefined criteria At the discretion of senior management Prioritize based on risk Consider severity and frequency of occurrence Risk to patient, user safety, business, regulatory Individual high risk failures QMS Consulting, Inc. 2007 42
Summary "The customer doesn't expect everything will go right all the time; the big test is what you do when things go wrong." -Sir Colin Marshall, CEO of British Airways QMS Consulting, Inc. 2007 43
Summary Understand the difference between corrective action and preventive action and how it relates to data analysis Utilize the output of design control to drive CAPA Define criteria for CAPA, monitor data directly linked to decisions implemented to control risk, set action limits Utilize multiple sources of data to illustrate significant issues Take a global approach to analyzing quality data to detect recurring problems QMS Consulting, Inc. 2007 44
Thank-You! Sue Jacobs QMS Consulting, Inc. 1566 West Algonquin Road Hoffman Estates, Illinois 60195 USA 1 847 359 4456 sue@qmsconsultant.com www.qmsconsultant.com QMS Consulting, Inc. 2007 45