Working Paper by the United Kingdom of Great Britain and Northern Ireland : The Role and Importance of Auditing in On-Site Activities (WP.223)

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AD HOC GROUP OF THE STATES PARTIES
TO THE CONVENTION ON THE PROHIBITION
OF THE DEVELOPMENT, PRODUCTION AND
STOCKPILING OF BACTERIOLOGICAL
(BIOLOGICAL) AND TOXIN WEAPONS AND
ON THEIR DESTRUCTION

BWC/AD HOC GROUP/WP.223
19 September 1997

Original: ENGLISH

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Eighth session
Geneva, 15 September - 3 October 1997

Working paper submitted by the United Kingdom
of Great Britain and Northern Ireland

THE ROLE AND IMPORTANCE OF AUDITING IN ON-SITE ACTIVITIES

INTRODUCTION

1. On-site auditing was identified in VEREX as one of the possible on-site verification measures. Auditing was defined as the "examination within a facility boundary, in accordance with agreed standards and criteria, of documentary records, electronically held data and manuals, to assess consistency of matters recorded and materials accounted with declared purposes and permitted activity." The United Kingdom believes that this measure, in conjunction with visual observation and interviewing of personnel, plays a key role in the conduct of effective investigations. However, this does not mean that all documentation must be examined. In practice, on-site auditing activities are limited: inspectors have no need for a widespread documentary analysis; and inspected facilities have moreover the right, where necessary, to restrict access to sensitive documents etc. under managed access techniques.

2. Auditing taken in isolation certainly does not provide definitive proof for the presence or absence of illegal biological warfare activities. However, auditing is an important on-site tool for both investigations and visits. It is an effective means for gathering confirmatory evidence which helps answer, explain and clarify questions and issues that emerge as on-site activities unfold. Examination of documentation, for example, helps explain and account for the presence and use of equipment. Such background information in turn builds confidence that equipment has been used as claimed.

THE UNITED KINGDOM'S EXPERIENCE

3. The role and limitations of on-site auditing was one of the topics investigated during the United Kingdom's four practice compliance inspections. We were keen to see whether scrutiny of documents was possible without posing an unacceptable risk to commercial proprietary information. This paper provides examples of the roles and importance of on-site

GE.97-64307

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auditing taken from specific scenes in the inspection programme. Many of these lessons have been reinforced during continuing practice inspections at sensitive defence facilities as part of the United Kingdom's CWC implementation preparations.

(i) Categories of documents and records

4. Inspectors sought access to a range of documentary information, not usually in isolation but as one of various types of information requested as a line of enquiry developed. The types of information requested included fermentation and down-stream processing records, batch deviation records, maintenance records, culture collection lists, quality control records, warehouse inventories, off-site waste disposal logs, safety data sheets for specific materials, site diagrams, building floor plans, site safety and emergency procedures, accident log records and reports, and documentation kept for domestic regulatory purposes such as Control of Substances Hazardous to Health, the Medicines Control Agency, the Veterinary Medicines Inspectorate, and the Advisory Committee for Genetic Manipulation. Access to some medical or occupational health records (other than individual personal medical records) was also requested including statements of immunization policy and lists of vaccines.

(ii) Extent and scope of access

5. In most cases comprehensive access was possible, but there were times when the facility refused access to given records because it felt this would pose an unacceptable risk to commercially sensitive data. However, in such cases facility personnel were often happy to offer random selective access to individual documents. For example, when inspectors requested access to a Cell Culture Collection list, the facility was able to offer four pages chosen at random from the list (and if necessary it would have been possible to confirm that individual cultures selected from the log were actually held on site). On other occasions sensitive data, such as the metabolite produced by the microorganism, was blanked out, but there was still sufficient data on the page to show that the nature of the work was nothing to do with offensive BW. These principles can equally be applied to equipment operating protocols or product manufacturing instructions.

(iii) Utility

6. At one facility the record-keeping system meant that the movement of every microorganism received was recorded as it moved between laboratories on the site. Inspectors were thus able to cross-check the receipt and despatch of microorganisms from specific buildings as well as the general nature of the work done on individual organisms. On another occasion documents such as disposal and batch deviation records were examined as a way of accounting for failed batches or periods

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when fermenters were unused. (Facilities are anyway obliged to keep such records if their product is subject to US Food and Drug Administration or UK Medicines Control Agency procedures.) Maintenance and power consumption records played a comparable helpful role in clarifying equipment down times.

CONCLUSIONS

7. Information obtained by auditing reinforces and builds confidence in the consistency and plausibility of information acquired by other measures such as interviewing, visual inspection and identification of key equipment. It is unusual for a question that arises in the application of one of these on-site measures not to have some read-across to information which could be provided by auditing - or indeed other on-site measures. The degree of reinforcement when the various categories of information agree - or do not agree - is a major factor in building confidence about the site's activities.

8. The extent to which Inspectors are able to have access to records and to put these in context may vary from site to site. In the case of the UK's practice inspections access to many types of document (e.g. site diagrams) was often possible on an unrestricted basis. Other documents were commercially sensitive, such as those revealing output or the identity of a particular metabolite, and access had to be controlled on a managed access basis. This did not however diminish the utility of auditing. Auditing works alongside other on-site measures, all of which are closely interdependent, thereby providing inspectors with a much more meaningful view of a facility's activities. It is the combined effect of the on-site measures, including on-site auditing, which makes for effective investigations and visits.

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