A robust Corrective and Preventive Action (CAPA) system is integral to drive quality improvements and operational excellence in bio-pharmaceutical organizations. Therefore, it is imperative for quality leaders to evaluate the effectiveness of their CAPA processes to improve the productivity of their function. Best Practices, LLC undertook benchmarking research to help companies achieve best-in-class performance in three important areas critical to the quality function: CAPA Process Management, CAPA Performance Benchmarks and Quality Resource Management. Quality leaders can refer to this study to develop a robust CAPA system and thereby build a robust quality function, within limited resources. Download Full Report: http://bit.ly/2dzgpZ5

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Best Practices, LLC Strategic Benchmarking Research
Benchmarking BioPharma
Quality and CAPA Processes

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Table of Contents
 Executive Summary Pgs. 3-6
 Research Overview Pg. 4
 Participating Companies Pg. 5
 Definitions and Abbreviations Pg. 6
 Key Findings and Insights Pgs. 7-10
 CAPA Benchmarks and Defining CAPA Pgs. 11-18
 CAPA Effectiveness Metrics Pgs. 19-24
 FDA Questions, Inspections and Observations Pgs. 25-28
 Best Practices for Building a Strong CAPA System Pgs. 29-30
 Quality Spend Levels and Trends Pgs. 31-36
 Quality Staff Levels Pgs. 37-41
 Quality Spend Mix Pgs. 42-48
 Quality Reporting and Ownership Pgs. 49-53
 Quality Spend Drivers Pgs. 54-59
 Outsourcing Quality Pgs. 60-64
 Best Practices for a Robust Quality Function Pgs. 65-66
 Demographics Pgs. 67-71
 About Best Practices, LLC Pg. 72-73

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Field Research & Insight Development:
Best Practices, LLC recruited Quality function and
CAPA Process executives at 14 biopharmaceutical
organizations to share their data and insights in a
customized benchmarking study.
Respondents were surveyed through an online
benchmarking instrument, validated through
telephone conversations. Top performers were
engaged via phone interviews.
Assist companies in achieving top-
tier performance in three important
areas critical to Quality:
• CAPA Process Management
• CAPA Performance Benchmarks
• Quality Resource Management
Research Objectives & Methodology
Research Objectives:
Business Objective:
This benchmarking initiative focuses on:
 Assessing CAPA processes
 Uncovering strong benchmarks for CAPAs, NCEs, FDA Questions, Inspections
and Observations
 Defining CAPA effectiveness metrics
 Measuring the true cost of Quality
 Highlighting strategies to manage quality costs and align spend mix

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Universe of Learning: 14 BioPharma Companies Participated
This benchmarking study engaged 14 executives from leading biopharmaceutical organizations. Data
is charted throughout this report for the “Total Benchmark Class” (TBC) as well as for the “Large
Company Segment” (LCS), which includes 9 companies with biopharmaceutical revenues above $5B.
Large Company Segment
• Associate Director, Process
Excellence
• Director, Global CAPA and Change
Control
• Vice President, Quality
• Director of Quality
• SVP, Quality
• Director, Quality
• Executive Director, Quality
• Head of Quality, Biotechnology
• Director, Supply Chain
Management
• Director, Continuous Improvement
• Sr. Director, Quality Assurance
• Director, Quality Assurance
• Sr. Director, QA
• Sr. Manager
Participant TitlesTotal Benchmark Class

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Definitions and Acronyms
Management
Factors
Process
The following definitions and acronyms were used in this research study.
• CA: Corrective Action
• CoQ: Cost of Quality
• FTE: Full-time Employees
• LCS: Large Company Segment
• NCE: Non-Conforming Event
• PA: Preventive Action
• Q FTE: Quality FTEs
• Q Spend: Quality Spend
• Q: Quality
• QMS: Quality management System
• TBC: Total Benchmark Class

6. Key Findings & Insights: Benchmarking BioPharma Quality and CAPA Processes
 Volume of Open CAPAs: The way that companies define start and end points of CAPA plays
a critical role in understanding the CAPA success of the companies.
 While companies with strict definitions of CAPA end points may have high number of open
CAPAs, the companies with loose end point definition may end up having less open CAPAs.
As a result utilizing a wide range of different metrics to provide deeper information about CAPA
process effectiveness and minimize the effects of definitions on CAPA measures are critical.
 CAPA Effectiveness: Companies are still trying to find the best ways to measure
effectiveness of their CAPA processes. There can not be “one size fits all” approach, because
of the differences in products and processes of the companies.
 We observed that benchmarked companies fall behind in preventive activities, since the
targeted ratio of preventive actions is higher than the actual.
 Quality Spend & Staff Levels and Trends: Complexity factors, regulatory restrictions and
process management factors are the top areas that effect Quality resource levels. To ensure
lower costs, companies must manage the factors that they can have high control on.
6

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Companies Moving Toward Earlier Management of CAPAs
Fifty-Six percent of TBC defines Entrance of the Information into the Quality Management System as the
CAPA start point, while one-third uses Discovery of an Event as the start point of CAPA. Companies
using Discovery as a CAPA start point event typically report superior corrective vs. prevention metrics.
Q22. Start and End Point of a CAPA: How do you define the start and end of a CAPA in your organization?
N=9
Other response: “During and after investigation of an unplanned deviation.”
Investigation
Necessity of
CAPA(s) (Yes/No)
If Yes, Put in
QMS System
Entrance into
QMS System
Investigation
Implementation
QMS Start Point Discovery Start
Point
Discovery of an
event
33%
Entrance of the
information into
the Quality
Management
System Tool
56%
Other
11%
CAPA Start Point

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Top CAPA Effectiveness Metrics: Recurrences and Repeats
More than half of the benchmark class uses Number of Recurrences and Number of Repeats to
measure effectiveness of CAPA processes.
Q25. CAPA Effectiveness: Please select the metrics that you use to measure your CAPA effectiveness.
N=8
88%
75%
50%
50%
38%
38%
38%
25%
13%
Number of recurrences
Number of repeats
Completion of action timelines
Frequency of non-conformances
Frequency of complaints confirmed as nonconformance
Frequency or number of product recalls
Complaint closure timelines
Frequency or number of investigations which reach root
cause
Investigation timelines
CAPA Effectiveness Metrics - TBC
% Respondents

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A Strong CAPA System is Critical for the Success of Quality
Function
Management
Factors
Process
STRONG
CAPA
SYSTEM
Align Definitions:
Aligning definition
of CAPA with the
performance
evaluation metrics
is critical to
understand
success of CAPA
processes
Adjust CAPA
Processes: It is
important to adjust
CAPA processes
with the product
portfolio and
complexity factors
to hit CAPA targets
Increase
Prevention: High
preventive-action
ratios allow
companies to avoid
future corrective
actions
Use the Right
Metrics:
Identifying metrics
that align with the
company targets is
critical for the
success of CAPA
processes
Keep Strong
Records: Keeping
exact records with
proper tracking of
all the CAPA
related events aids
early identification
of issues
Maintain
Conformance with
Regulations:
Ensure that
implementation and
effectiveness of
CAPA aligns with
regulatory
demands

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Choose the Right CMO to Avoid Outsourcing Failures
An important component of outsourcing is working with CMOs. It is critical for companies to create a
high set of standards when choosing the CMOs that they work with.
Identifying
manufacturing
capabilities
Experience
with the
company’s
products
Understanding
the strength of
Quality system
within the
CMO
Registration to
the country’s
regulatory
bodyAlignment
between the
capacity of the
CMO and the
company’s
demand
Understanding
of deviation
reporting and
investigation
Pathway to
choose the
right CMO
Choosing the Right CMO

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85%
85%
86%
88%
88%
91%
98%
17%
15%
16%
14%
14%
9%
2%
Regulatory Affairs
Training
Audit Management (Internal and External)
Operational Excellence/ Continuous Improvement
Operational Excellence/ Continuous Improvement
Compliance
Quality Assurance
Outsourcing Quality - TBC
% of Activities Done In-House: % of Activities Outsourced
A Majority Utilizes In-House Quality Capabilities
More than 90% of the benchmark class manage Quality Assurance and Compliance activities in-house.
In addition, more than 80% of the TBC do not outsource other activities.
N=9
Q17. Managing Quality Labor Costs: Please estimate the percentage of total Quality
activities that are done in-house vs. outsourced.

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About Best Practices, LLC

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Best Practices®, LLC is an internationally recognized thought leader in the field of best practice
benchmarking®. We are a research, consulting, benchmark database, publishing and advisory firm that
conducts work based on the simple yet profound principle that organizations can chart a course to superior
economic performance by leveraging the best business practices, operating tactics and winning strategies of
world-class companies.
6350 Quadrangle Drive, Suite 200
Chapel Hill, NC 27517
(Phone): 919-403-0251
www.best-in-class.com
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