OHSAS 18001 and Potent Compound Safety Programs

Just the other day, I received the latest version of the Occupational Health and Safety Assessment Series (OHSAS) guideline and began to dive into reading this 80+ page document. For those of you unfamiliar with OHSAS 18001, it is an internationally recognized assessment specification for occupational health and safety management systems that is published by the British Standards Institution (BSI). As I started to get into the document, I couldn’t help but wonder how such a specification might be used to provide a model for an effective and sustainable potent compound safety program. So over the next several weeks, I will review each of the main parts of the specification and suggest how it might be applied to biotechnology, pharmaceutical, and medical device companies that are in the process of designing and implementing a potent compound safety program. At some point, I will put together a table that describes each of the main BS OHSAS 18001 points and the corresponding components of a potent compound safety program.

Overview of BS OHSAS 18001

Let’s begin by providing a high-level overview of BS OHSAS 18001 (hereafter, refer to as OHSAS 18001). OHSAS 18001, like its environmental counterpart ISO 14001, is management system assessment guideline that follows the familar plan-do-check-act (P-D-C-A) cycle to ensure continuous improvement. One important point to make about BS OHSAS 18001 is that it is not a compliance assessment tool and just because you can achieve BS OHSAS 18001 certification does not necessarily mean that you are in full compliance with every legal requirement. The text of 18001 states that in the organization’s OHSAS policy top management must define and authorize the policy such that it includes a commitment to at least comply with applicable legal requirements…that relate to its OH&S hazards.

The main components of OHSAS 18001 include:

  1. Scope,
  2. Normative references
  3. Terms and definitions
  4. OH&S management system elements, which includes:
    1. general requirements
    2. establishment of an OH&S policy
  5. Planning
    1. hazard identification, risk assessment and determining controls (I’m looking forward to discussing this section since we will get to cover potent compound risk assessments, control banding, and containment)
    2. legal and other requirements
    3. OH&S objectives and programe(s)
  6. Implementation and operations
    1. resources, roles, responsibility, accountability, and authority
    2. competence, training and awareness
    3. communication, participation and consultation
    4. documentation
    5. control of documents
    6. operational control
    7. emergency preparedness and response
  7. Checking
    1. performance measurement and monitoring
    2. evaluation of compliance
    3. incident investigation, nonconformity, corrective action, and preventative action
  8. Control of records
  9. Internal audit
  10. Management review

The document that I have is the guideline for the implementation of OHSAS 18001:2007 and contains a significant amount of detail. In order to keep each blog post to a relatively short read, I’ll stop here and next week we will discuss the importance of defining scope and the general requirements of the guideline. In the mean time, if you would like to discuss OHSAS and potent compound programs please contact me. For part 2 go here.


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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