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Date: Thursday, October 6, 2011Time: 1:00pm – 2:30pm Eastern Daylight Time (GMT/UT 1700)

12:00pm – 1:30pm Central Time 11:00am – 12:30pm Mountain Time 10:00am – 11:30am Pacific Time

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FDA’s Increased Emphasis on CAPA: Insights & Advice from a Former FDA Official & Industry Experts

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FDA’s Increased Emphasis on CAPA:Insight & Advice from a Former FDA Official & Industry Experts

An FOI Services Teleconference

Presented October 6, 2011 by:Denise Dion; formerly with FDA

Jodie Bastian; Stryker CorporationJonathan Lee; formerly with MedtronicMichael Santalucia; Bausch & Lomb Nancy Singer; formerly with AdvaMed

Mark Soderberg; Covidien

Denise Dion

Organization Name:Formerly at U.S. Food and Drug Administration

Former Title: Medical Device Expert Investigator

Background:Over 18 years as an FDA Investigator

Contact Information:[email protected]

2

Jodie Bastian

Company Name: Stryker Corporation

Size of Company: Multi‐billion dollar, Fortune 500 Medical Device company

Types of Products: Mainly orthopaedic implants, digital imaging systems and surgical instruments and hardware

Scope of Responsibility: Oversees the implementation of an effective, company‐wide CAPA system

Contact Information: [email protected]

3

Jonathan Lee

Company Name: Formerly at Medtronic

Former Title: VP Regulatory, Quality & Clinical Services, Medtronic Surgical Technologies

Company Size: MDT=US$15 billion; Surgical Technologies=US$1 billion

Types of Products: Class 1, 2 & 3 imaging, monitoring, implantable & surgical instrumentation

Scope of Responsibility: QMS, product quality, regulatory clearance & clinical evaluation from nine global locations

Contact Information:[email protected]

4

Mike Santalucia

Company Name: Bausch & Lomb

Title: Vice President of Regulatory Affairs

Size of Company: Multi‐billion dollar company; 10,000 employees

Types of Products: Pharmaceuticals, contact lenses, contact lens care products, IOLs, and surgical devices

Scope of Responsibility: Management and oversight of medical device products to provide global regulatory strategies, submissions and compliance guidance


5

Mark Soderberg

Company Name: Covidien Respiratory & Monitoring Solutions

Title: Director of Quality Systems

Size of Company: $1.2 billion

Types of Products: Ventilators, pulse oximeters, patient monitoring devices, airway products

Scope of Responsibility: Managing global quality management systems, including the design, production & process controls, CAPA, supplier quality, factory and field services, and documentation and records management


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Q1. What are key terms for CAPA?

Denise Dion, former FDA Medical Device Expert Investigator– Nonconformity – Correction– Corrective Action– Preventive Action

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Q2. How does FDA define “Nonconformity”?

Denise Dion, former FDA Medical Device Expert Investigator– 21 CFR 820.3– Nonconformity means the nonfulfillment of a specified

requirement.

8

Q3. How does FDA define the other terms?

Denise Dion, former FDA Medical Device Expert Investigator– FDA Boston Workshop; June 29‐30, 2010. ISO 9000:2005(E)

• “Correction” Action to eliminate a detected nonconformity1. A correction can be made in conjunction with a corrective

action.2. A correction can be, for example, rework or regrade.

• “Corrective action” ‐ Action to eliminate the cause of a detected non‐conformity or other undesirable situation; there can be more than one cause for a nonconformity

1. Corrective action is taken to prevent recurrence.2. There is a difference between correction and corrective action.

• “Preventive action” Action to eliminate the cause of a potential non‐conformity or other undesirable situation

1. There can be more than one cause for a potential nonconformity.

2. Preventive action is taken to prevent occurrence.

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Q4. Where are the requirements for CAPA?

Denise Dion, former FDA Medical Device Expert Investigator– 21 CFR 820.100

• Identify quality data sources• Document and evaluate all nonconformances• Investigate to root cause when needed• Identify and implement corrective and preventive action• Ensure effectiveness of corrected action• Trend quality data

10

Q5. What are the most important qualitydata that need to feed into your CAPA system?

Denise Dion, former FDA Medical Device Expert Investigator– Complaints– Incoming, in process and finished product testing– Nonconformances– Internal and suppliers audits– Equipment – Calibration maintenance– Environmental and process monitoring

Industry Practices– Bausch & Lomb (Mike)– Covidien (Mark)

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Q6. What criteria should be used to determine when to elevate a nonconformance to a CAPA?

Denise Dion, former FDA Medical Device Expert Investigator– For a product: An indication that it caused or contributed to

death, serious injury or illness.– For a product or process: If the nonconformance is occurring

beyond expected frequency or severity or in an unexpected manner.

Industry Practices– Stryker (Jodie)– Medtronic (Jonathan)

12

Q7. What documentation can we use to determine whether we need to open a CAPA?

Denise Dion, former FDA Medical Device Expert Investigator– Design and process risk documentation– Knowledge of previous investigations to understand different

failure modes• Post‐market• Design phase

Industry Practices– Covidien (Mark)– Stryker (Jodie)

13

Q8. Should firms let anyone open a CAPA or have an advisory committee make these decisions?

Denise Dion, former FDA Medical Device Expert Investigator– In the gray areas you might want to have a variety

of expertise.

Industry Practices– Medtronic (Jonathan)– Bausch & Lomb (Mike)

14

Q9. What is a failure investigation?

Denise Dion, former FDA Medical Device Expert Investigator– Part 1: The initial evaluation is done as part

of the nonconformance investigation.• Is it valid?• What is the extent of the problem?• What is its impact?

– Part 2: The root cause investigation• Cause for occurrence• Cause for escape

– Part 3: Identification of corrective or preventive action• Verify and validate

Industry Practices– Stryker (Jodie)– Bausch & Lomb (Mike)

15

Q10. What are some documentation practices for failure investigations?

Denise Dion, former FDA Medical Device Expert Investigator– Define the method of investigation– The dates of investigation activities– The data that was reviewed– Description and reference to any tests performed

and why this is appropriate– The corrections and containment measures taken– Determined cause

Industry Practices– Medtronic (Jonathan)– Bausch & Lomb (Mike)

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Q11. If I do a failure investigation, do I always have to get to the definitive root cause?

Denise Dion, former FDA Medical Device Expert Investigator– No.

• Probable cause• Rule out • Two reasons why we don’t always get to root cause


17

Q12. What are common mistakes in CAPA documentation?

Denise Dion, former FDA Medical Device Expert Investigator– Inflammatory words (negligent, careless, dangerous)– Opinions rather than facts– Generalities– Vague statement (not specifying who, what, and when)– Passive voice used without describing the actor;

e.g., “The records were reviewed.”


18

Q13. How many days should a company allow for the investigation of a CAPA?

Denise Dion, former FDA Medical Device Expert Investigator– At least 30 days to get to root cause and identify the needed

corrective and preventive action– Need to update the record as you go

Industry Practices– Bausch & Lomb (Mike)– Covidien (Mark)

19

Q14. What should the goal be for closing CAPAs?

Denise Dion, former FDA Medical Device Expert Investigator– The goal should be based on the priority of risk – The higher risk needs to be sooner– If that is not possible, the firm should document the file

Industry Practices– Bausch & Lomb (Mike)– Stryker (Jodie)

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Q15. What criteria do you use to make the determination that a CAPA is closed?

Denise Dion, former FDA Medical Device Expert Investigator– Corrective action is complete– Any needed preventive action is in place– Effectiveness has been demonstrated

Industry Practices– Covidien (Mark)– Bausch & Lomb (Mike)

21

Q16. What is meant by an effectiveness check?

Denise Dion, former FDA Medical Device Expert Investigator– Effectiveness is an action taken to determine if the CA or PA

truly did reduce or eliminate the occurrence or reoccurrence of the nonconformance or potential nonconformance due to the indentifying cause.

– It is not the task required to implement the CA/PA.

Industry Practices– Covidien (Mark)– Medtronic (Jonathan)

22

Q17. How do you monitor CAPAs which are open for an extended period of time?

Denise Dion, former FDA Medical Device Expert Investigator– At least every 30 days:

• Generate periodic aging reports about all open CAPAs• Hold periodic meetings to discuss open CAPAs• Discuss open CAPAs through emails

– Update the record as activities occur


23

Q18. Which department should be in charge of CAPAs?

Denise Dion, former FDA Medical Device Expert Investigator– RA or QA or both

Industry Practices– Bausch & Lomb (Mike)– Covidien (Mark)– Stryker (Jodie)– Medtronic (Jonathan)

24

Q19. How should companies trend their CAPA/quality data?

Denise Dion, former FDA Medical Device Expert Investigator– Procedures for data trending should look across the data

sources, not just within the data sources– Procedures for trending need to include who trends, when,

and what– Management review process may be used to describe

trending processes – management needs to know why the nonconformances occurred, not just how many

Industry Practices– Bausch & Lomb (Mike)– Medtronic (Jonathan)

25

Q20. What type of CAPA data should be included in management reviews?

Denise Dion, former FDA Medical Device Expert Investigator– Key process, products and quality system performance

indicators• Management must be aware of not just the number of complaints, CAPAs or non‐conformances, but the reason (root causes) for these.

• It is important for management to be aware of what is wrong with the quality system.

Industry Practices– Stryker (Jodie)– Covidien (Mark)

26

Q21. When a decision is made not to open a CAPA, should that be justified in writing?

Denise Dion, former FDA Medical Device Expert Investigator– Yes.– Need to document

• Why no further investigation is needed• The name of the person making the decision • The date

Industry Practices– Covidien (Mark)– Medtronic (Jonathan)

27

Q22. What do you think are the biggest challenges firms have investigating CAPA events?

Denise Dion, former FDA Medical Device Expert Investigator– Determining when no further investigation is needed– The number of investigations and the time to conduct

the investigation– Identifying the root cause– Completing the investigation on time– Lack of training on conducting the right investigation– Writing the investigation report


28

Q23.Describe techniques you might use to get cooperation of all departments to investigate and close CAPAs.

Denise Dion, former FDA Medical Device Expert Investigator– Quality is everyone’s job.– Include being in compliance with FDA requirements

as an element in job descriptions and goals.– Have a triage when CAPAs are really needed.


29

Q24. If you use an electronic system to monitor CAPAs, what are its pros & cons?

Denise Dion, former FDA Medical Device Expert Investigator– The electronic system needs to work with any

nonconformance reporting systems for trending purposes– Need audit trail for all data fields– Must be validated for intended use

Industry Practices– Bausch & Lomb (Mike)– Covidien (Mark)– Stryker (Jodie)– Medtronic (Jonathan)

30

Q25. What are key publications for CAPA?

Denise Dion, former FDA Medical Device Expert Investigator– 21 CFR 820.100 and the preamble to QSR– QSIT Guide– Compliance Program 7382.845– AdvaMed Points to Consider on QSIT– Guidance for Industry – Investigating Out of Specification

(OOS) Test Results for Pharmaceutical Production, September 1998

31

Q26. If a company has put a nonconformance in their CAPA system, will that prevent FDA from citing it on the FDA Form 483?

Denise Dion, former FDA Medical Device Expert Investigator– Technically no– Can cite you for how well you conduct or document

the investigation– On occasion FDA investigators have cited firms


32

Q27. If a company combines their internal audits with their CAPA files, will this prevent FDA from looking at the CAPA data?

Denise Dion, former FDA Medical Device Expert Investigator– No.– If you want to protect your internal audits, you need

to separate them from your CAPA files.


33

Q28.What types of 483 citations did FDA cite in 2010?

• Failure to establish and maintain procedures 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.

• Failure to establish and maintain procedures for investigating the cause of nonconformities relating to product, processes, and the quality system.

• Failure to maintain procedures for implementing corrective and preventive action as required by 21 CFR 820.100(a).

• Failure to identify and initiate corrective actions.

34

Kim Trautman’s Talk on Global Compliance

• Time frame: January 1, 2010 through December 31, 2010• 3,434 observations cited for 21 CFR 820 deficiencies

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January – December 2010

QS # Warning Letters Percentage Subsystem with Citation

CAPA 81 91P&PC 69 78MGMT 43 48DESIGN 49 55DOC 33 37

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Observation by Subsystem

CAPA = 1,058P&PC = 1,045MGMT = 522DES= 452DOC= 357‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐Total= 3,434

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Thank You! Questions?

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If you think of a question later, or would like to discuss an issue in a private setting, you are invited to contact a speaker directly. (Contact information is on pages 2‐6.) You may also submit your question(s) to the moderator, Nancy Singer, at [email protected] or +1‐703‐525‐4159.

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