Prepare to Succeed

CAPA Build a Culture of Quality to Achieve Life Sciences Market Leadership

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Introduction Are you concerned with building quality and compliance within your Life Sciences organization?

Do you need to move your products to market more quickly?

Do you have a plan for maintaining or improving customer satisfaction and your brand’s reputation?

Are you managing global risk effectively to reduce errors that can lead to patient harm?

Management Review

Effectiveness Review and Follow-up

Implementation of Action Plans

Verification and Validation

Develop Action Plans

Analyze Problem

Document Problem

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This eBook is your roadmap to building a Culture of Quality based on CAPA best practices and improvements. It presents 10 improvements that your organization can implement that will help leverage CAPA best practices to achieve market leadership.

Patient safety, risk management, brand reputation and market share are just some of the concerns currently facing Life Sciences organizations. It can be difficult to manage and measure these initiatives without the proper tools or processes in place.

The good news is that a rigorous process around Corrective and Preventive Actions will go a long way towards meeting your goals in each of these areas. Plus, you will be in compliance with FDA regulatory requirements when you do.

Let us show you how >>

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Table of Contents

Understand the CAPA Basics 5

Recognizing Current CAPA Challenges 11

Build a Compliant CAPA Process 15

Leverage CAPA to Build Market Leadership 32

Contact Information 51

References 52

Understand the CAPA

Basics

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CAPA Basics If you are reading this e-book and work

with medical devices, drugs or in any

area of the highly regulated Life

Sciences industry, you are very likely

familiar with or responsible for your

organization’s Corrective and Preventive

Action (CAPA) process.

If your Life Sciences organization has ever received a 483 or Warning

Letter from the Food and Drug Administration (FDA), chances are that

some part of your CAPA process was cited.

85% of FDA Warning Letters to

Medical Device companies

cited CAPA in 2011 *

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FDA Focus on CAPA In accordance with its Quality System Inspection Technique (QSIT), the FDA typically examines four major quality management subsystems during an audit.

CAPA Production

and Process Controls

Design Control

Management Review

Source: http://www.fda.gov

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Top Citations In recent years, the prevalence of CAPA citations for Life Sciences organizations has remained steady.

This means that CAPA Citations are not a new trend. These citations are part of a continuing trend in Life Sciences organizations of all types. (Torres, 2012)

79

88 87 84

88 88 91

85

70

75

80

85

90

95

2004 2005 2006 2007 2008 2009 2010 2011

Percent of warning letters each year with a CAPA citation

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CAPA Regulations for Medical Devices CAPA process requirements for Medical Device Manufacturers are indicated in 21 CFR Part 820, specifically 820.100. Medical Device Manufacturers are required to “establish and maintain procedures for implementing corrective and preventive action.”

Part 820 requires process steps for:

ü  Problem analysis and detection (this can include statistical analysis)

ü  Investigation

ü  Identification of corrective and preventive action plans

ü  Verification and validation of the corrective or preventive action

ü  Change implementation and documentation

ü  Communication of quality problems to affected personnel

ü  Management review of problems and their associated CAPA

ü  Documentation of all activities and results related to the above requirements

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CAPA Regulations for Drugs FDA’s 21 CFR Part 211 for Pharmaceutical organizations requires investigation of batch failures. This includes the investigation of the “failure of a batch or any of its components to meet any of its specifications …. whether or not the batch has been distributed.” Part 211.192 further requires that “A written record of the investigation shall be made and shall include the conclusions and follow-up.”

Source: http://www.fda.gov

Other Pharmaceutical industry standards, such as ICH Q10, provide the guidance needed to develop a corrective and preventive action process that drives continuous improvement.

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Recognizing Current CAPA

Challenges

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CAPA Touches Everything FDA and other industry requirements are stringent and comprehensive. Moving forward along the road to market leadership requires an understanding of both regulatory requirements and the challenges that may occur as your organization builds a compliant process.

Some of the challenges you may face stem from the simple fact that CAPA can touch every part of your business. This includes audits, complaints, inspections, adverse events, suppliers, equipment, change control, document management and even training requirements.

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FDA Focus on Documentation CAPA is also challenging because the FDA wants documentation for each

step of every CAPA. The FDA looks for specific markers when evaluating

the efficacy of a company’s CAPA system:

ü  Where the quality system detects a CAPA event and sets it apart

ü  How the CAPA process functions and if it complies with GMP and

Quality System Regulations

ü  When the process is monitored

ü  Who controls the process and ensures that it is brought to a satisfactory

conclusion

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Too Much Data in too Many Systems When people, products, processes and facilities are added to the organization due to growth (either organic or by acquisition), the CAPA process can grow out of control. Communication and follow-up become cumbersome to maintain.

The broad reach of CAPA processes and the large volume of documentation required has created increasing amounts of data in an increasing number of systems. These systems include disparate databases, excel spreadsheets, home-grown and even paper-based systems. As a result, reporting becomes time-consuming and trend analysis is either neglected or simply impossible to conduct.

Build a Reliable CAPA

Process

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Establish a Baseline We began our journey on the road to market leadership by understanding CAPA compliance requirements and the challenges in meeting these requirements. Next, we will explore improvements that can move your organization toward a compliant and reliable CAPA process. This will establish a baseline − a well-run process that can later be leveraged to accelerate your organization’s journey to market leadership.

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A Reliable CAPA Process Managing CAPA can be challenging. The first step toward compliance is to build a reliable CAPA process.

Let’s focus on 5 improvements that will help your organization build a reliable CAPA workflow.

Document Process

Solidify Root Cause

Analyze Trends

Integrate Change

Maintain Involvement

improvement

1 Document Your Process

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Document Your Process Best practice CAPA workflows integrate with other business processes such as audits, inspections, equipment monitoring, change control and more. A good CAPA Standard Operating Procedure (SOP) includes the basics:

ü  People or roles involved

ü  Processes to be monitored

ü  Risk levels

ü  Actions to take throughout the CAPA process

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Document Your Process The FDA indicates numerous steps to be included in each CAPA process. Each of these steps should be included in your CAPA documentation and each step in your process should be logically related to the next.

ü  Detection

ü  Analysis

ü  Investigation

ü  Verification

ü  Validation

ü  Change Implementation

ü  Communication

improvement

2 Solidify Root Cause Analysis

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Solidify Root Cause Analysis Corrective and Preventive Action cannot be effective without understanding the fundamental reason for the problem.

This sounds elementary, but the “Bandaid” approach to root cause analysis costs Life Sciences businesses countless dollars each year. Why?

Because when problems recur, they create more damage to patients, corporate compliance efforts and brand reputation.

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Solidify Root Cause Analysis Utilize (and document your use of) classic root cause analysis tools such as fish-bone diagrams, 5 Whys, Is-Is Not and Fault Tree Analysis to understand the true cause of each problem.

Understanding the underlying cause of each nonconformance drives the appropriate corrective and preventive action plans and prevents costly defects from reoccurring.

Don’t rush to solve the problem until the cause is understood.

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improvement

3 Analyze Trends to Understand Risk

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Analyze Trends to Understand Risk

A risk-based approach to CAPA means that low severity and easily detected problems may not need immediate attention, while riskier defects that could cause patient harm are promptly investigated.

When an FDA auditor walks through your door, a high number of CAPA records can be a trigger for further investigation. Any resulting citations are costly and damaging to your brand’s reputation.

Despite intense regulatory pressure, not every deviation, complaint, audit finding or supplier defect should trigger a CAPA.

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Analyze Trends to Understand Risk

Trend analysis can also be useful in monitoring and mitigating minor problems that could give rise to riskier issues later in the product lifecycle. If you want to reduce time to market, it is simpler and less time consuming to correct each nonconformance or deviation earlier in the process.

Applying a systematic definition of potential failure modes, and conducting trend analysis as defects are detected, can improve your ability to understand where to focus your CAPA efforts. (Claycamp, 2006)

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improvement

4 Integrate Change

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Integrate Change Change is a natural output of the CAPA process. In fact, change and continuous improvement are the results of a best practice CAPA workflow.

Tying the CAPA workflow directly to the change management process ensures that appropriate changes are implemented whether the CAPA end result calls for document-based change, retraining, new procedures or any other type of change.

Managing corrective and preventive change contributes to continuous improvement initiatives throughout the organization.

improvement

5 Maintain Management Involvement

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Maintain Management Involvement A CAPA process is not effective or compliant without management commitment. Managers who understand CAPA procedures and conduct management reviews of CAPA data and records keep the CAPA process in compliance and reduce their risk of 483s.

In typical Life Sciences organizations, CAPA is a reactive tool used to remedy defects, deviations, complaints or other incidents of poor quality. It is critical to have this process in place as defects are bound to occur in all organizations. Forward-thinking managers understand that a compliant and reliable CAPA process can increase patient safety and protect the corporate brand.

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Maintain Management Involvement Management commitment to the CAPA process is essential to moving forward along the road to market leadership. Moving from complying with regulations to building a Culture of Compliance can be accomplished by further improving and leveraging the CAPA process.

These improvements can help Life Sciences organizations move from a model of quality as a cost, to quality as a competitive differentiator, and to use this differentiator to achieve market leadership.

Leverage CAPA to

Build Market Leadership

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Drive Process Improvement with CAPA A Life Sciences organization that is focused on compliance will need to spend time developing and maintaining processes as well as reacting to problems. Process improvements beyond the required baseline CAPA process will move an organization from a Culture of Compliance to a Culture of Quality.

In a Culture of Quality, organizations are proactive in seeking improvements and changes. They are no longer simply satisfied or concerned with forced compliance; rather, they seek process improvements which enhance overall product and service quality.

Next, let’s review 5 additional improvements that can leverage the already required CAPA process to increase patient safety, build a better brand, and move products to market more quickly.

improvement

6 Focus on Prevention

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Culture of Compliance Reactive

Culture of Quality Market Leader

Concerned with regulatory

compliance

Concerned with improving the

business

Spends time reacting to problems

Proactively identifies areas

for improvement

Concerned with developing and maintaining the CAPA process

Leverages required CAPA processes to

improve products and move faster

than their competition

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Focus on Prevention Don’t wait for a problem to appear to use the CAPA process. The preventive aspect of CAPA can eliminate defects before they cost your organization time and money. Once your CAPA process is well-defined and compliant, use it to identify and implement opportunities for improvement.

Preventive action most heavily impacts the bottom line, as avoiding defects and deviations reduce costs associated with rework. In addition, preventive actions reduce the potential for liability, warranty claims, fines and negative publicity. This is an area where many organizations, including your competitors who have implemented corporate-wide CAPA systems, fail to make progress.

improvement

7 Be a CAPA Detective

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Be a CAPA Detective Make every effort to detect problems as early as possible. This means early in the product lifecycle and early in the value chain.

Problems discovered later have greater negative impacts, including increased:

ü  Problem severity

ü  Time to resolve

ü  Cost to resolve

ü  Cost to your brand

Customer Experience

Production

Sourcing

Design

Cost Impact

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Be a CAPA Detective The ability to identify and address a problem at any point throughout an organization’s product or process value chain is an important feature of any good CAPA system.

Cost Impact

Whether an issue crops up at a supplier, during the manufacturing process, or after product distribution, the FDA wants to know that it will be immediately identified and handled appropriately.

improvement

8 Learn From the Past

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Learn From the Past Trend and signal analysis can help to detect problems early on, before they become high severity, customer-facing problems. However, trend analysis is only effective if you know what to look for.

How do you know which defects have the potential to lead to problems?

Market-leading life sciences organizations leverage lessons learned through CAPA to feed the R&D process. The link between CAPA and R&D forms a closed loop that allows lessons learned from one product to feed design for the next.

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Learn From the Past CAPA data and insights can be used to reduce your time to market and develop the safe, high-quality products needed to increase your market share.

R&D Receiving Production Customer

Experience

CAPA CAPA

CAPA

improvement

9 Sharing Makes You Great

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Sharing Makes You Great There are numerous ways to share lessons learned. It can begin with moving product defect data back to design. But you have more options for sharing knowledge to drive innovation.

Can you share product related lessons learned with relevant vendors? Or with other sites within your organization?

What about audit results? Vendor, internal, customer and regulatory audit results can be shared with other departments or sites to improve their compliance and continuous improvement efforts.

These efforts can build efficiencies throughout your business and allow everyone to focus on product safety and faster time to market.

improvement

10 Technology is a CAPA Tool

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Technology is a CAPA Tool Unless an integrated quality system is in place, most departments and sites track and trend their own data on their own systems, marking it hard for management to see a corporate-wide compliance picture.

Without this vision, key personnel cannot predict and prevent possible deficiencies and meet CAPA regulations. Automated enterprise systems allow you to trend, communicate, share and innovate in ways that are impossible with manual systems.

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Moving Toward Market Leadership Your organization may need to build processes required to achieve compliance, or you may be ready to leverage compliance practices to gain competitive advantage.

In either case, Pilgrim Quality Solutions provides both the flexible solutions and the industry expertise needed to support your organization’s goals. Are you ready to move toward market leadership?

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“ “ It is not enough to do your best; you must know what to do, and then do your best.

W. Edwards Deming

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Quality and Compliance Solutions Since 1993, leading manufacturers and service providers have relied on Pilgrim Quality Solutions for the expertise needed to tackle their toughest operational and compliance challenges.

Pilgrim supports the Life Sciences industry by automating, streamlining and effectively managing processes required to develop and maintain safe, high-quality and innovative products and services.

Pilgrim's integrated suite of software solutions is based on industry best practices and tested business solutions. Our process-oriented solutions lead to world-class, superior performance by building compliance and quality management into key business operations.

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Contact Us Pilgrim Quality Sales

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www.pilgrimquality.com

   

Prepare to Succeed

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References ü  Torres, M. (2012). Current FDA Inspection and Enforcement Trends [PowerPoint

slides].

ü  Claycamp,H. Gregg, Ph.D. (2006). ICH Q9: Quality Risk Management [PowerPoint slides].

ü  Guide to Inspections of Quality Systems: Quality Systems Inspection Techniques (QSIT):http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm

ü  Q10 Pharmaceutical Quality System:http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128031.pdf

ü  CFR Title 21 Database:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm