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The Significance of a CAPA Program as a ‘Bellwether’ for Overall Compliance Efforts Victoria V. Lander IDEX Corporation 21cfrpart11.com

Capa ‘Bellwether’

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Page 1: Capa ‘Bellwether’

The Significance of a CAPA Program as a ‘Bellwether’ for Overall Compliance Efforts

Victoria V. LanderIDEX Corporation21cfrpart11.com

Page 2: Capa ‘Bellwether’

What is the Cost of Quality?

"Cost of quality is the amount of money a business

loses because its product was not done right in the

first place. From fixing a warped piece on the assembly

line to having to deal with a lawsuit because of a

malfunctioning machine or a badly performed service,

businesses lose money every day due to poor quality.

For most businesses, this can run from 15 to 30

percent of their total costs."

- American Society for Quality

Page 3: Capa ‘Bellwether’

Agenda

The Quality Challenge for the GxP Industry

What is a CAPA?

CAPA Implementation & Issues

ISO 13485 and 21 CFR Part 820

Summary

Page 4: Capa ‘Bellwether’

Background

Page 5: Capa ‘Bellwether’

Quality Challenges

Increasing Role for Pharmaceuticals in Health Care

Increased Number of Products

Greater number, and wider range, of drugs being manufactured

Globalization of the Pharmaceutical Industry

Increase in foreign manufacturing sites

Advances in Pharmaceutical Science, Like Application of Biotechnology to Drug Discovery and Manufacturing

More Complex and Diverse Manufacturing

Increasing Number of Manufacturing Supplements Submitted for Agency Review

Page 6: Capa ‘Bellwether’

Benefits of a CAPA System

To Strive to Improve Quality

To Recognize Existing or Potential Quality Issues

To Initiate Appropriate Steps Necessary to Investigate and Resolve these Issues

To Make Sure that the Same Issues Do Not Reoccur

Reduce Risk to Patients

Increase Quality Suppliers and Components

Products Designed and Tested to Meet Customer Requirements

Waste Elimination

Page 7: Capa ‘Bellwether’

Satisfying Compliance With CAPA

A Proactive, Automated Approach to a Quality System

Capturing All Corrective Action Issues and Tracking CA Processes to Completion

About 30% to 50% of All FDA 483s are Related to Problems with CAPA Processes

Corrective Action is Core of Quality Management Disciplines Such As...

Six Sigma DMAIC (Define, Measure, Analyze, Improve and Control)

TOPS-8D (Team-Oriented Problem Solving, 8 Disciplines)

ISO 9000

Page 8: Capa ‘Bellwether’

Top FDA 483 Items

QSIT Inspected Firms

CAPA (30%)PAPC (20%)

Records (10%)

Mgmt (40%)Source: Medical Device & Diagnostic Magazine, January 2002

Page 9: Capa ‘Bellwether’

Common CAPA Violations

No Established Procedures for Implementing CAPA

No True Root-cause Analysis, Failure Investigations Inadequate

Complaint Handling Too Specific, Do Not Look at Overall System

Failure to Document CAPA Action

No Validation

Failure to Designate & Document Executive Responsibilities

Infrequent Quality Audits

Inadequate Procedures for Quality Audits

Inadequate Procedures for Design Changes

Inadequate Procedures for Documenting CAPA

Lori S. Lawless, FDA, RAPS, October 2003 in Baltimore

Page 10: Capa ‘Bellwether’

CAPA Basics

Page 11: Capa ‘Bellwether’

Definition

•Corrective Action – The Action to Eliminate the Causes of a Detected Nonconformity or Other Undesirable Situation

•The CA Should Eliminate the vRecurrence of an Issue

Page 12: Capa ‘Bellwether’

Definition

• Preventive Action - Action to Eliminate the Cause of a Potential Nonconformity or Other Undesirable Potential Situation

• PA Should Prevent Occurrence

• Examples:• Design Reviews, Trend Activities, Audits, Process vMonitoring, Risk Management Processes, etc.

Page 13: Capa ‘Bellwether’

CAPA is a Systematic Approach

Define the Problem

Determine Root Cause

Implement Corrective Action

Implement Preventive Action

Verify Effectiveness of Implemented CAPA

Document and Disseminate “Close-out”A CAPA Follows an Assigned Workflow Process…Assures All Variables Related

to Quality are Addressed

Page 14: Capa ‘Bellwether’

Key Elements of a CAPA System

Corrective Action to Eliminate the Cause of the Issues

Preventive Action to Prevent Potential Issues from Occurring

Data Collection, Analysis and Monitoring

Prioritization of Issues Based on Risks

Active Management Participation

Comprehensive, Complete CAPA Records / Documentation

“Close the Loop” - Was the Resolution Effective?

Initiate for Deviations, Nonconformance, Out-of-Specifications, Complaints (Reactive)

BUT… Approach Should Also be Proactive

A CAPA Solution Must be an Integrated Part of a Quality and Compliance Solution

Page 15: Capa ‘Bellwether’

Enterprise-Wide Approach

An Internal Agreement for CAPA Definition

Must be reflected throughout entire firm

All Departments Will be Involved in CAPA

Not just Quality Assurance or Compliance

CAPA as an Integrated Part of a Sound Quality System

It can’t function in a vacuum

Also Used to Evaluate Entire Quality System and Other Sources of Quality Data

Effective CAPA Programs Should Fully Interact with Change Control System

Page 16: Capa ‘Bellwether’

Define Your CAPA Process: Key Questions

Who Will Initiate CAPAs?

How Will they be Initiated?

Will other systems drive the CAPA initiation?

How Will CAPAs be Assessed and Investigated?

How Will All CAPAs be Evaluated for their Applicability?

What Completion Requirements Set for Certain CAPA Activities?

Length of Investigation Before Creating Correction SOP?

Interoperability of CAPA with Other Quality Processes?

e.g., PAT, QSIT, Risk Management

Did You Include Your Change Control System in Your Planning?

How Will You Monitor CAPA System for Effectiveness?

Page 17: Capa ‘Bellwether’

Software and CAPA

Software Helps in Managing & Tracking CAPA Process

Functionalities in a CAPA IM System Should Include …

Web-based change management, audit trails and tracking

Visualization, reporting, and quality performance analytics

Configurable workflows

Standard template-based best practice workflows

Roles-based information view

Event management

Integration into back-end systems

A modular structure, capable of being incrementally deployed

Source: AMR Research

Page 18: Capa ‘Bellwether’

CAPA Data Considerations

Product and Quality Data Sources

How will the Data be Captured

How will the Data be Analyzed

Including methods of analysis

When will the Data be Analyzed

What Steps are Taken After Analysis

“Review of the CAPA system document noted that all quality data sources have not been identified, such as:

• All in-process production test data sources and the routine analysis performed on these data sources; • Various data sources for complaints, failure analysis and repair data from in-house to distributors”

JUNE 11,2003 Roche Diagnostics Corporation Indianapolis, Indiana, USA

Page 19: Capa ‘Bellwether’

Quality Data Sources

Clinical Adverse Reactions

Internal, External, Supplier and Third Party Audits

Installation Feedback

Spare Part Usage

Acceptance Activity - Records Relating to Components

In Process Failures - Reworks and Discards

Finished Product Failures - Reworks

Complaints - Returns and Repairs

Field Service and/or Warranty Reports

Corrective and Preventive Actions

Lawsuits and Other Legal Actions

Published Literature

Reports from Employees

Page 20: Capa ‘Bellwether’

Elements of an Effective System

Use a “Closed-loop Process”

Include Written Procedures and SOPs Used to Define the Closed-loop Process

Define Responsibility for Managing the CAPA and Distributed it to the Organization

Establish Sequential Activities that Identify, Correct or Eliminate Existing or Potential Problems

The tool for managing the closed-loop system

Implement an Information System for Managing the Information Associated with CAPA

Use Effectiveness Checks to Confirm that Action Prevented the Recurrence (or Occurrence)

Page 21: Capa ‘Bellwether’

Quality Regulations

Page 22: Capa ‘Bellwether’

GMP

EN 46000ISO 13485/8? QSR

ISO 13485

ISO 13485

ISO 9001

Quality System Regulations

Page 23: Capa ‘Bellwether’

About ISO 13485 & ISO 13488

Harmonized EU Medical Device Quality System Similar to EN 46000 plus Additional Requirements

ISO 13485:1996: Medical Devices - Used with ISO 9001

For manufacturers performing own design activities

ISO 13488:1996: Medical Devices - Used with ISO 9002

For manufacturers without design activities

Certification of a Quality Management System to ISO 9001/ISO 13485 (EN 46001)

Essential for Global Exportation

Third-party Verification that System Meets Requirements

US 21 CFR 820 Based on this (and ISO 9000)

Page 24: Capa ‘Bellwether’

ISO 13485 Corrective Actions Requirements

ID Nonconformities & Determine their Cause

Including customer complaints

Evaluate Need for Action to Prevent Recurrence of Nonconformities

Determine and Implement Action Needed, Including Updating Documentation

Record Results of Any Investigation & Action Taken

Review Corrective Action Taken and Effectiveness

“Shall be Appropriate to the Effects of the Nonconformities Encountered”

Page 25: Capa ‘Bellwether’

ISO 13485 Preventative Actions Requirements

ID Potential Nonconformities and their Causes

Evaluate Need for Action to Prevent Occurrence of Nonconformities

Determine and Implement Any Action Needed

Record Results of Any Investigation and Actions Taken

Review Preventative Actions Taken and Effectiveness

“Eliminate Causes of Potential Nonconformities to Prevent their Occurrence”

Page 26: Capa ‘Bellwether’

21 CFR Part 820: Sub-part J

ID Action Needed to Correct and/or Prevent Nonconformance and Other Quality Problems

Employ Appropriate Statistical Methodology to Detect Recurring Quality Problems

Investigate Causes of Nonconformities for Product, Processes and Quality System

Ensure that Information for Quality Problems is Disseminated to those Responsible for Assuring Product Quality

Submit Information on Quality Problems and CAPA for Management Review

Document All Activities and Results Required Under this Section

Verify or Validate the CAPA

Page 27: Capa ‘Bellwether’

21 CFR Part 820: Sub-part J

Analyze the Following to ID Causes of Nonconformance or Other Quality Problems …

Processes

Work operations

Concessions

Quality audit reports

Quality records

Service records

Complaints

Returned products

Other sources of quality data

Page 28: Capa ‘Bellwether’

FDA Warning Letter

“Failure to adequately establish and maintain procedures for implementing corrective and preventive action, which include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems, as required by 21 CFR 820.100(a) (1).” June 11, 2003

Roche Diagnostics Corporation Indianapolis, Indiana, USA

Page 29: Capa ‘Bellwether’

The FDA and CAPA

Strength of CAPA Program is Important Indicator that Impacts FDA Inspectors’ View of Other Compliance Efforts

e.g. 21 CFR Part 11, Predicate Rules

When FDA Finds Strong CAPA Program at Outset of Inspection, it’s a “Bellwether” for Your Overall Quality Compliance Programs

Despite the FDA’s Recent Moves to Narrow Enforcement of Part 11, Regulated Firms Should Bank on Agency Scrutinizing CAPA More During Inspections

http://www.fda.gov/cder/gmp/index.htm

Page 30: Capa ‘Bellwether’

Summary

Address Your Culture

Conduct Independent Reviews

Simplify Documentation

Use a “Closed-Loop” System

Monitor Your Process

Change With Your Business

Participate in Industry Meetings

Talk to People/Peers

Never Stop