GHTF Study Group 4 Report

Work Programme:

The initial focus of the work of Study Group 4 has been to complete the guidance supplements to the general requirements document SG4(99)28 dealing with training requirements for auditors (Supplement No 3) and the estimation of audit duration (Supplement No. 2). A supplement identifying all of the documentation that would normally be associated with regulatory audits has been prepared to clarify Clause 5.7 in the General Requirements. In addition, the group has developed a supplement setting out guidance proposals for observed audits for confidence building. Both of these, Supplements 4 and 6 respectively, have been issued as 'Proposed documents' for public comment.

The group's main attention is now on the development of an audit report documentation system to cover all details of information relevant to the manufacturer, nonconformities and observations recorded during the regulatory audit. The approach being developed is designed to be suitable for application by auditing organizations for electronically recording and evaluating detailed audit information and for exchanging audit information between regulatory agencies.

The group has been concerned to show evidence that its work was being used to harmonize approaches to regulatory audits. A report is being prepared therefore identifying the manner and scope of application of the General Requirements document by Founder Member and other countries. This report should be completed very soon. This report is also intended for other agencies not currently involved with the group but planning to introduce regulatory quality management requirements to the manufacturers of medical devices and where auditing was an element of the regulatory process. In this, it is designed to provide such agencies with information to demonstrate that the GHTF auditing guidance was achievable as well as good practice and so encourage consideration of its wider application.

Key Documents Published During the Report Period and their Status'

Estimation of audit duration: Supplement No 3 - Ready for approval as Final document by GHTF

Compilation of audit documentation (Clause 5.7): Supplement No 4 - Proposed document.

Observed audits for confidence building: Supplement No 6 - Proposed document.

New Work Item Proposals

FDA has proposed in the past that the group should consider developing guidance on the strategy that regulatory auditing organizations should apply more recently presented its audit strategy, QSIT, to the group. As a result, the group is now considering adding the development of guidance on audit strategy to its work programme.

Meetings

The group has had three meetings since the last GHTF Conference. These have been held in Dublin, Ireland (13 -15 October 1999), Munich, Germany (15-17 March 2000) and currently, in Ottawa, Canada, as part of the 8th GHTF Conference programme.

Membership

During the period of this report, the following longstanding members have left or are leaving the group, Christine Nelson (FDA), Egid Hilz (COCIR) and Robert Wurzel (HIMA). We would like to take this opportunity to thank them for their significant contributions to the group's work.

The group has always looked to establish contact with experts in countries outside of the original membership. During the period of this report we have been pleased therefore to welcome Mr Albert T W Li (Industrial Technology Research Institute, Taiwan), Mr Kyung-Man Lee (Korea Testing Laboratory) and Mr Markus Zobrist (Swiss federal Office of Public Health)

Robert Allen joined the UK Department of Health in 1976 after working in the UK National Health Service and industry. Currently, he holds the position of Section Head of European Regulatory Affairs 2 (ERA2) with responsibility for medical device clinical investigation reviews, registration of medical devices, and the designation of UK Notified Bodies and Conformity Assessment Bodies. Mr. Allen is also the Chair of GHTF Study Group 4 (Auditing) and Chairman of ISO/TC 210.