EU Unannounced Audits (UAV) Experience To Date Medical Device Single Audit Program (MDSAP) Copyright 2015 BSI. All rights reserved.

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Claribel Charles
5 years ago
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EU Unannounced Audits (UAV) Experience To Date Medical Device

Background & Requirements - See Webinars BSI

BSI Resources http://medicaldevices.bsigroup.

5 Who? Commission Recommendation specifies at least two assessors BSI Assessment Team One QMS Assessor (Client Manager) One Product Technical Specialist In advance briefing preparation by the Scheme Manager Often not the regular assessor(s) Copyright 2015 BSI. All rights reserved. 5

6 Where? Legal Manufacturer? YES if all or some manufacturing, design or test activities performed onsite for all or some products Critical Subcontractor or Crucial Supplier? YES, for virtual manufacturers Copyright 2015 BSI. All rights reserved. 6

7 Where? if this is likely to ensure more efficient control in particular if the main part of the design development, manufacturing, testing or another crucial process is located with the subcontractor or supplier. Critical Subcontractor E.g. Manufacturer of finished devices, key sub-assembly or significant components. Regulatory responsibility and / or activities essential for ensuring compliance with legal requirements. Design or software development, sterilisation, sterile packaging. Crucial Supplier E.g. Critical raw materials such as silicone gel component for an implant, animal tissue for use in heart valve. Proprietary items. Copyright 2015 BSI. All rights reserved. 7

8 How is the determination made? Information Collection & Review Information collated from manufacturer via Scheme Manager Form completed please ensure updates notified (IT Portal for future) Scheme Manager reviews & compiles plan BSI Plan Finalized In most cases one Unannounced Audit to one manufacturer (or their CS/CS) in one 2 or 3 year period In some cases there may need to be more than one location visited Visit Scheduled Audit assigned to a QMS Assessor & Product Technical Specialist Copyright 2015 BSI. All rights reserved. 8

9 What information should we have on file? Facility Details Access details: Hours of operation, contact names & phone numbers, PPE / Health & Safety requirements, language skills on site, shutdown periods etc. Critical Subcontractors & Crucial Suppliers (CS/CS) Details of device types, activities performed & frequency + all above Copyright 2015 BSI. All rights reserved. 9

10 How often? Per Commission Recommendation & NB Code of Conduct Minimum frequency in number of years for Classification an unannounced visit Is / Im IVD self test IIa IIb III / AIMD IVD List A Normal conditions 3 yr 3 yr 3 yr 2 yr If the device bears high risk 2 yr 2 yr 1 yr 1 yr Devices that are often non-compliant 2 yr 2 yr 1 yr 1 yr Specific reasons for suspicion 2 yr 2 yr 1 yr 1 yr Version July 2014 Copyright 2015 BSI. All rights reserved. 10

11 For how long? Most Manufacturers - Including small & medium sized facilities - One day by two auditors Very Large Manufacturers - Several hundred employees + - Four man-days (or more in extreme cases). Likely two assessors for two days - Or an increase in frequency of visits Copyright 2015 BSI. All rights reserved. 11

12 What happens on the day? Arrival BSI Assessors present an introduction / overview letter referencing the objective, EC Certificate(s), location to be assessed, date and assessment team Identification The letter contains a link to the BSI website which contains names and photos of all assessors authorized to conduct Unannounced Audits for BSI Copyright 2015 BSI. All rights reserved. 12

13 What happens on the day? BSI Assessors arrive onsite and present identification (letter and weblink) Request to speak to allocated contact or the most senior person on site Explanation of visit within brief opening meeting Audit team progress swiftly to manufacturing area Assessment team work together to audit all elements specified in the Commission Recommendation and identify areas / processes for further audit as part of the visit Brief closing meeting, with details of findings where possible Report will be provided within approximately one week Follow up of any non-conformities through normal audit processes Copyright 2015 BSI. All rights reserved. 13

14 What happens on the day for a CS/CS? BSI Assessors arrive onsite and present identification (letter and weblink) Request to speak to allocated contact or the most senior person on site Explanation of visit within brief opening meeting Audit team progress swiftly to manufacturing area Assessment team work together to audit all elements specified in the Commission Recommendation and identify areas / processes for further audit as part of the visit Brief closing meeting, with details permission of findings / phone where attendance possible of Legal Manufacturer & details of findings where possible Report will be provided within approximately one week Report provided to Legal Manufacturer within approx one week Follow up of non-conformities any via normal through audit normal processes audit processes (at any location) Copyright 2015 BSI. All rights reserved. 14

15 What happens on the day if? No manufacturing or other processes ongoing? Review applicable evidence? E.g. Recent activity, warehouse stock, physical areas used, i.e. manufacturing, design, records etc and associated documentation If CS/CS (& within limits of confidentiality) review similar activities/processes/areas Assessment team judgement to a recommendation on audit validity Audit team is refused or denied access Assessors complete report providing full details of situation encountered Directly inform BSI Scheme Manager (& BSI notify Legal Manufacturer if CS/CS) Note any refusal or non co-operation will lead to review & follow-up action Potential escalation to certificate scope reduction, suspension or cancellation Copyright 2015 BSI. All rights reserved. 15

Timelines March 2014 April 2014 May June 2014 July 2014 > BSI trial period Several Unannounced Audits conducted as trials across a range of companies and devices BSI live with routine Unannounced

17 Timelines March 2014 April 2014 May June 2014 July 2014 > BSI trial period Several Unannounced Audits conducted as trials across a range of companies and devices BSI live with routine Unannounced Audits (per European Competent Authorities expectations) Small volume conducted Global roll-out of internal training (5 events and 140 people) Finalized practises, polices and procedures Full global roll out and ramp up, with significant volume of routine Unannounced Audits across remainder of Continuous internal review, policy finalization and refinement Copyright 2015 BSI. All rights reserved. 17

18 What did we learn? So far all were ready, including small manufacturers Some surprise (from auditees) at:- The assessment team working together No detailed assessment agenda Different focus to normal visits. i.e. more on product, less on supporting QMS processes (No routine coverage of Management Review, Internal Audit, CAPA etc) Having a visit so soon! Feedback indicated a more positive experience than expected! Copyright 2015 BSI. All rights reserved. 18

19 What did we learn? Key Points A very few manufacturers are still to return requested critical information to BSI to enable effective planning Audits have been conducted to locations which would not have been visited had the information been available (e.g. move ongoing, a planned site closure) Lack of returned information does not mean no Unannounced Audit. Lack of response could trigger EC certificate suspension or cancellation Copyright 2015 BSI. All rights reserved. 19

20 What did we learn? Key Points Unusual situations encountered Manufacture site moving or moved Re-modellers in facility Audit from a national regulator ongoing CE Certificate about to be cancelled Our procedures & training emphasise the importance of speedy access to manufacturing Please help no long factory tours or routing, cups of coffee (can be later), network passwords, navigation / access issues Copyright 2015 BSI. All rights reserved. 20

21 What happened on the day? Assessment Agenda - BSI Assessors have detailed briefing but no fixed assessment agenda - Following arrival and overview meeting generally swift progress to manufacturing and / or final product areas Typical Timings - Morning spent in product areas, then working lunch - Afternoon finish production etc, then more office-based, documentation audit trails link to Technical Files & Dossiers - End of day wrap-up / brief closing meeting Copyright 2015 BSI. All rights reserved. 21

22 Are you ready? Have you? 1. Studied the requirement? 2. Factored additional costs into budgets? 3. Implemented processes and procedures for receiving visits? 4. Responded to requests from your NB? 5. Reviewed (or are reviewing) critical subcontractors & crucial suppliers contracts? 6. Communicated awareness across all staff and trained appropriate staff? 7. Practised? 8. Had one?! Did you conduct a post-audit review to learn from the experience? Copyright 2015 BSI. All rights reserved. 22

On the day 1. Ensure guide(s) assigned 2. Be aware of requirement & assist the auditors, e.g. get to manufacturing as soon as possible 3. Let the assessment team know of any concerns or issues (e.g. no CE devices in production that day, fire alarm planned) 4.

23 On the day 1. Ensure guide(s) assigned 2. Be aware of requirement & assist the auditors, e.g. get to manufacturing as soon as possible 3. Let the assessment team know of any concerns or issues (e.g. no CE devices in production that day, fire alarm planned) 4. Think ahead remember likely need access to Technical Files / Design Dossiers for devices 5. Feel free to ask questions (will they break for lunch, approximate time to wrap-up etc) 6. Conduct (& share?) internal post audit review on any learnings ready for next time?! Copyright 2015 BSI. All rights reserved. 23

25 International Medical Device Regulatory Forum (IMDRF) IMDRF Management Committee (MC) regulators: Australia, Brazil, Canada, China, the European Union, Japan and the United States of America Representatives of the World Health Organization (WHO) Regulators from the Russian Federation, Mexico, Asian Harmonization Working Party (AHWP) participate as affiliate organization Copyright 2015 BSI. All rights reserved. 25

26 IMDRF Work Groups National Competent Authorities Report Exchange Program Roadmap for Implementation of Unique Device Identification system Medical Device Single Audit Program List of Recognized Standards Regulated Product Submission Copyright 2015 BSI. All rights reserved. 26

27 MDSAP Goals Recognize Auditing Organizations (AO) Single Audit by AO would: benefit patient health and patient access leverage regulatory resources minimize medical device manufacturing disruptions due to multiple regulatory audits provide global benefit both on short term goals and longer term goals by IMDRF regulators Copyright 2015 BSI. All rights reserved. 27

MDSAP- Statement of Cooperation (November 2012) Australia Therapeutics Goods Administration (TGA) Brazil Agência Nacional de Vigilância Sanitária

28 MDSAP- Statement of Cooperation (November 2012) Australia Therapeutics Goods Administration (TGA) Brazil Agência Nacional de Vigilância Sanitária (ANVISA) Canada Health Canada/Santé Canada United States of America Food and Drug Administration (FDA) Copyright 2015 BSI. All rights reserved. 28

29 MDSAP Manufacturer Audit Criteria GMP requirements of the regulatory authorities One audit to address all Certification will be required Health Canada US FDA Brazilian ANVISA Australian TGA AO Audit Copyright 2015 BSI. All rights reserved. 29

30 MDSAP Manufacturer Audit Cycle The initial Audit is followed by a partial Surveillance Audit in each of the following two years and a complete Re-audit, also referred to as a Recertification Audit in the third year Special Audits, Audits Conducted by Regulatory Authorities, and Unannounced Audits are potential extraordinary audits that may occur at any time within the audit cycle. Copyright 2015 BSI. All rights reserved. 30

31 How Regulators will use MDSAP reports Australia: The Therapeutics Goods Administration TGA will use an MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorization requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports. Brazil: The Brazilian National Health Surveillance Agency ANVISA will utilize the outcomes of the program, including the reports, to constitute an important input on ANVISA s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support regulatory technical evaluation on these issues. Canada: Health Canada HC will use a MDSAP audit as part of their Canadian Medical Device Conformity Assessment System (CMDCAS) certification program. Upon the successful conclusion of the pilot, Health Canada's intent is to implement the Medical Device Single Audit Program, as the mechanism to achieve regulatory compliance for quality management system requirements in Canada. Copyright 2015 BSI. All rights reserved. 31

32 How Regulators will use MDSAP reports United States: U.S. Food and Drug Administration s Center for Devices and Radiological Health FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted "For Cause" or "Compliance Follow-up" by FDA will not be affected by this program. Moreover, this MDSAP program would not apply to any necessary preapproval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device. Japan s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are official observers and active participants in the Pilot Program s Regulatory Authority Council and subject matter expert groups. Copyright 2015 BSI. All rights reserved. 32

33 MDSAP Pilot January 1, 2014 Recognition of initial participating Auditing Organizations June 1, 2014 Some Auditing Organizations were ready to start auditing medical device manufacturers and more will be added as the pilot progresses. Copyright 2015 BSI. All rights reserved. 33

Medical Device Single Audit Program (MDSAP) Copyright 2014 BSI. All rights reserved.

Medical Device Single Audit Program (MDSAP) International Medical Device Regulatory Forum (IMDRF) IMDRF Management Committee (MC) regulators: Australia, Brazil, Canada, China, the European Union, Japan