In areas of considerable complexity it is necessary to demarcate who does what, and how and when and why, or be answerable for the consequences.

1. First there is the responsibility for preparation of the environmental policy, for ensuring that it is compliant with regulatory standards, and that local procedures are implemented in compliance with the policy. This is clearly a quality responsibility.

2. There are then the responsibilities for "doing" the environmental monitoring. This need not be detailed at this stage, but whereas most of this responsibility would normally be held by a quality group (such as QA microbiology), any components of the environmental program that are to be done by production (e.g., personnel monitoring may be done under the supervision of a production supervisor) or by engineering (e.g., monitoring of pressure differentials or total airborne particulate) should be clearly identified here. If responsibility for aspects of monitoring lies outside the quality group, there must be some means of periodic check monitoring or audit to ensure it is done properly.

3. There is the responsibility for training personnel in environmental monitoring.

4. There is the responsibility for defining how data are to be recorded and reported.

5. There is the responsibility for reviewing data and ensuring that there are appropriate reactions to all out-of-specification and atypical results. The responsibility for investigating such events, correcting them and ensuring that, they do not reoccur, may require a broader base.

6. Finally, there is the responsibility for periodic analysis and reporting of adverse trends in environmental data with a view to ensuring that potential out-of-specification conditions are "headed off at the pass."

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