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  • CAPA gap analysis: Tell me something I

    dont know about CAPA!

    10 February 2015

    Prepared by Diane Kulisek 1

    CAPA Gap Analysis: Tell Me Something I Dont Know

    About CAPA!

    10 February 20151

    Presented by Diane Kulisek for

    Topics to be covered:

    FDA CAPA Tripwires

    CAPA Investigations

    Reviewing and Correcting a Non-conformity

    Verifying CAPA Implementation and Validating CAPA Effectiveness

    Risk Management for CAPA

    Tips for Writing CAPA Plans

    10 February 2015 Presented by Diane Kulisek 2

  • CAPA gap analysis: Tell me something I

    dont know about CAPA!

    10 February 2015

    Prepared by Diane Kulisek 2

    FDA CAPA Tripwires

    10 February 2015 Presented by Diane Kulisek 3

    CAPA Gap Analysis: Tell Me Something I Dont Know About CAPA!

    FDA CAPA Tripwires The FDA has published data analysis in regard to Form 483 observations since 2003 and Warning Letter cites since 2004.

    In 2013, the FDA data indicated that CAPA issues have consistently been one of the top types of FDA observations or cites throughout the past decade.

    CAPA has consistently represented approximately 1/3 of all FDA Form 483 observations in FDA data analysis reports

    88%, 127 out of 144 Warning Letters issued, in 2013, cited CAPA deficiencies.

    10 February 2015 Presented by Diane Kulisek 4

  • CAPA gap analysis: Tell me something I

    dont know about CAPA!

    10 February 2015

    Prepared by Diane Kulisek 3

    FDA Inspectional Observationsby QMS Subsystem

    Source: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm416501.pdf

    10 February 2015 Presented by Diane Kulisek 5

    CAPA Represented 31% of all 2013 FDA Inspectional Observations

    FDA CAPA Tripwires (continued)

    Source: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm416501.pdf

    10 February 2015 Presented by Diane Kulisek 6

    CY2004 CY2013Warning Letters with QS Citations

    2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

    # of WLs 113 97 79 74 98 77 89 122 164 144

    FDA CAPA Tripwires (continued)

  • CAPA gap analysis: Tell me something I

    dont know about CAPA!

    10 February 2015

    Prepared by Diane Kulisek 4

    Source: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm416501.pdf

    10 February 2015 Presented by Diane Kulisek 7

    CY2013Warning Letters

    QS Subsystem # ofWLs w/CitePercentage

    (144 Total WLs)CAPA 127 88%P&PC 127 88%DES 91 63%DOC 77 53%

    MGMT 71 49%

    FDA CAPA Tripwires (continued)

    Source: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm416501.pdf

    10 February 2015 Presented by Diane Kulisek 8

    Observation (QS Regulation) # of Observ. Percent21 CFR 820.100(a)CAPA Procedures missing or inadequate.

    355 33%

    21 CFR 820.198(a)Complaint Procedures missing or inadequate; Complaint files not maintained or inadequately maintained.

    280 26%

    21 CFR 820.100(b)CAPA activities not documented or inadequately documented.

    133 12%

    21 CFR 820.90(a)Nonconforming product not controlled or inadequately controlled (procedures, evaluation, notification, documentation).

    120 11%

    21 CFR 820.198(c)Complaint Investigation not performed (without prior investigation for a similar complaint).

    71 7%

    21 CFR 820.198(e)Record of Complaint Investigation missing or inadequate.

    34 3%

    CAPA TOTAL : 993(of 1,085)

    92%

    Most Frequent 2013 CAPA Form 483 ObservationsFDA CAPA Tripwires (continued)

  • CAPA gap analysis: Tell me something I

    dont know about CAPA!

    10 February 2015

    Prepared by Diane Kulisek 5

    General Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/default.htm

    10 February 2015 Presented by Diane Kulisek 9

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

    For example, your firms CAPA procedure, as outlined in the quality manual document DRAFT L-001-2.12 Laatuksikirja, Quality Manual Mega Electronics Ltd, does not include requirements for analyzing quality data in order to identify existing and potential causes of nonconforming products, or other quality problems.

    Specific Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm381538.htm (first device WL of 2014)

    FDA CAPA Tripwires (continued)Examples of Actual 2014 CAPA Warning Letter Citations

    General Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/default.htm

    10 February 2015 Presented by Diane Kulisek 10

    Failure to maintain complaint files and to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:

    a. CAPA number C13004 documented (b)(4). Upon the FDA investigators request for the associated complaint

    record, your firms Quality Engineer indicated that the issue directly went to CAPA and that there was no entry of the incident on the feedback log.

    b. Section 9.2 of document number L-002-2.5 Myynti ja markkinointksikijra, Quality Manual Mega Electronics Ltd

    Sales and Marketing Manual, defines a complaint as a written, electronic, or oral communication that alleges deficiencies. However, section 9, Customer Feedback, of the same document does not instruct or refer to the

    process to be followed for documenting oral complaints.

    c. According to section 9.3 of document number L-002-2.5 Myynti ja markkinointksikijra, Quality Manual Mega Electronics Ltd Sales and Marketing Manual, customer feedback is recorded on a (b)(4) form and a determination is

    made whether the feedback is a complaint. However, the form does not contain an entry or criteria for complaints to be evaluated for Medical Device Reportability. Your firms Quality Manager indicated that such evaluation is

    performed by the Quality Engineer and recorded on the CAPA form for the complaint if a CAPA is opened.

    Specific Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm381538.htm (first device WL of 2014, contd.)

    FDA CAPA Tripwires (continued)Examples of Actual 2014 CAPA Warning Letter Citations (Contd.)

  • CAPA gap analysis: Tell me something I

    dont know about CAPA!

    10 February 2015

    Prepared by Diane Kulisek 6

    Failure to establish and maintain procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm did not have corrective and preventive action procedures in place at the start of our inspection.

    During the course of the inspection, you provided Corrective/Preventive Action Procedure, Revision Level 001 to our investigator. We cannot verify this procedure has been implemented.

    10 February 2015 Presented by Diane Kulisek 11

    Specific Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429201.htm (last device WL of 2014)

    General Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/default.htm

    FDA CAPA Tripwires (continued)Examples of Actual 2014 CAPA Warning Letter Citations (Contd.)

    FDA CAPA Tripwires (continued)

    Failure to establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example: Your firms Corrective Action procedures (Corrective Action System SOP-019 dated 11/15/2012 and Problem Reporting SOP-002 dated 11/15/2012) do not include: a) Requirements to verify or validate corrective/preventative action as effective and they will not adversely affect the finished device.

    b) Definitions of preventative actions or how preventive actions will be controlled.

    We acknowledge receipt of your revised Corrective and Preventive Action SOP-008, however it is inadequate in that it fails to include key requirements identified under 21 CFR 820.100(a)(1). For example: Your revised procedure does not include a requirement that appropriate statistical methodology shall be employed where necessary to detect recurring quality problems as required by 21 CFR 820.100(a)(1).

    10 February 2015 Presented by Diane Kulisek 12

    Specific Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm425532.htm (second to last device WL of 2014)

    General Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/default.htm

    Examples of Actual 2014 CAPA Warning Letter Citations (Contd.)

  • CAPA gap analysis: Tell me something I

    dont know about CAPA!

    10 February 2015

    Prepared by Diane Kulisek 7

    FDA CAPA Tripwires (continued)

    Create a matrix

    Include details of requirements as stated within the applicable regulation subsections: 21 CFR 820.90 (Nonconformances)

    21 CFR 820.100 (CAPA)

    21 CFR 820.198 (Complaints).

    Map the Gap

    Map your organizations procedures and content, detail, to each applicable regulatory requirement (perform a gap analysis).

    Close the Gap

    If any requirement (gap) has not yet been addressed (mitigated) within the Quality Management System, do so immediately.

    CAPA CAPA

    If the gap is significant, open a CAPA to track progress.

    10 February 2015 Presented by Diane Kulisek 13

    AVOIDING FDA CAPA Form 483 Observations and Warning Letter Citations

    FDA CAPA Tripwires (continued)

    Create and use a checklist

    to perform internal audits of your quality systems that represents all of the requirements for the applicable regulation subsections.

    Use templates To document Nonconform