OHSAS 18001 and Potent Compound Safety, Part V – Hazard Identification and Risk Assessment

potent compound safetyWell it has been a busy week at Affygility Solutions, but I’m finally back on track with this series on OHSAS 18001 and Potent Compound Safety. In this part of the series I will discuss Hazard Identification and Risk Assessments. At this stage of program development, you will need to pull together all the various programs and procedures that you currently are using to identify occupational health and safety hazards, the risk assessments techniques that you may use, and how you determine the types of controls you will use to mitigate the risks.

This is a perfect place to take your potent compound categorizations and control banding procedures , extract them and integrate them into your overall OHSAS program. Additional documents and procedures that may be included in this part of your overall OHSAS program can include:

  • Qualitative Exposure Assessment Procedures
  • Quantitative Exposure Assessment Procedures
  • Process Hazard Reviews (PHA)
  • Occupational Toxicology Reviews
  • Personal Protective Equipment Assessments
  • Risk Assessments for Non-Routine Tasks (note: this is important and most companies don’t do a very good job at meeting these requirements)
  • Lockout/Tagout Equipment Reviews
  • Confined Space Entry Reviews
  • Electrical Hazard Reviews
  • New facility or renovation of facilities reviews
  • EHS facility inspection procedures
  • And many others

After the hazards have been identified, the risks must be assessed. As you may recall, in the EH&S world, risk is defined as:

Risk = Severity of Hazard X Probability

If you’re examining specifically potent compounds, the severity of the hazard will likely map over real well to your hazard banding scheme. It doesn’t matter how many bands you use, just as long as you’re consistent and it reflects the actual number of control scenarios that you have at your facility.

Once you have the degree of hazard then you will calculate the probability of an accident or incident occurring. The probability can be based on a number of factors, including:

  • Frequency of the activity
  • Duration of the activity
  • Number of employees involve
  • History of prior accidents/incidents/complaints

There are numerous established systems for determining risk and these can include:

  • Failure modes and effects analysis (FMEA)
  • Hazard and operability reviews (HAZOP)
  • Risk matrices (my personal favorite because they are very visual and easy to use)
  • Pareto analysis
  • Zurich Risk Assessments

You will also need to incorporate some form of management of change into your risk assessments. As you may know, if this is a process safety management (PSM) regulated facility, a management of change procedure may be required.

Well, I’m past my 500 word commitment, so next post I’ll talk about controlling risks. If you have any questions please contact me at Affygility Solutions. You can also email me directly at dcalhoun@affygility.com with your questions. If the questions are applicable to the general audience, I will be happy to post replies on this blog.If you happen to visit our website, please check out our project profiles. In addition, please feel free to link to our website by using the URL: http://affygility.com.


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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