OHSAS 18001 and Potent Compound Safety – Part II:

In Part I of this series, I provided an overview of the OHSAS 18001 standard and how it might provide a useful model for an effective and sustainable potent compound safety program. In today’s post, I will be discussing the general requirements in the specification and the importance of defining the scope of the effort.

OHSAS 18001 Management System General Requirements

In the text of the standard, it is stated that “The organization shall establish, document, implement, maintain and continually improve an OHSAS management system…” All of the language in the standard stresses permanency, continuous improvement, and an ongoing effort on the part of the organization to keep the management system going and effective. The general requirement of the standard is ensuring continuous improvement. This should not be understated. In many years of experience, I’ve seen very good programs crumble and evaporate because of changes in either leadership at the top or less inspired EH&S management. While implementation of these types of programs generally requires some champion to get it started, going it alone without full support is difficult and generally not sustainable over time. You will always have a few naysayers, but as we indicate in our Advanced Potent Compound Safety webinar, establishing an effective potent compound safety program takes teamwork and cooperation from many groups, including research, clinical development, facilities, manufacturing, EH&S, and others.

OHSAS 18001 and Potent Compound Safety Scope

When embarking on any management system approach to EH&S, it’s critical to carefully define the scope of the activities to be covered. As indicated in the guidelines for implementation of OHSAS 18001, an organization can choose to implement their management system throughout the organization, or subdivisions, or individual facilities. They do stress in the guidelines that the range of the scope has to be consistent with the definition of a “workplace.” When using this framework to establish a potent compound safety program, it can be expected that only certain facilities will handle the higher potency compounds so ensure that those facilities are part of the scope.

Well it’s very early at Affygility Solutions and I have a long day of auditing so I’ll end my post here. Next time I will discuss defining and creating an OHSAS policy.


About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

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