With all the current buzz about Risk Assessment brought about by API Spec Q1 9th Edition, API Spec Q2 and the circulating draft of the ISO 9001 possible 2015 version, how is one supposed to know when to do risk assessment? Before API Spec Q1 9th Edition or API Spec Q2 came up with the concept of Risk Assessment, it had already been prescribed by two perhaps not-so-common standards: OHSAS 18001 Occupational Health and Safety Management Systems and ISO 27001 the Information Security Management System.
Once you have selected your risk assessment methodology and crafted your risk assessment procedure, the next step is to carry out the actual risk assessment. Using this simple premise of doing it right the first time and every time, when should we really do a risk assessment?
When you first deploy your quality management system, EHS program or information security management system, risk assessment is required to be conducted. After the initial Risk Assessment effort, ongoing Risk Assessment may be scheduled as a yearly event, but that should be viewed as a minimum, pending other possible triggers. The API Specification Q1 9th Edition or API Specification Q2 do call for a review of Risk Assessment during the Management Review, which could help to ensure that Risk Assessment was done well or to identify any risks not correctly assessed. Miriam Boudreaux is the CEO and Founder of Mireaux Management Solutions, a technology and consulting firm headquartered in Houston, TX. Aside from craft questions, Time Management is maybe the number one issue writers bring up. A:  It is the act or process of planning and exercising conscious control over the amount of time spent on specific activities, especially to increase effectiveness, efficiency or productivity. What event or activity in my business or personal life can I eliminate to make room for writing?

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While the first one placed emphasis on assessing safety hazards in your processes, the second one focused on assessing risks that could affect the confidentiality, integrity and availability of information.
Make sure you invite the management team and any process owner, to ensure they not only feel involved but also that they take ownership of the management system being implemented. In this case, I suggest you conduct it after your main process mapping session and midway during your procedure development phase. Rather than repeating the effort, having a list of discarded risks may help streamline the process during your next Risk Assessment review. For example, API Specification Q1 9th Edition and API Specification Q2 both require that risk assessment be done every time there is a Management of Change.
This will promote awareness as well as help ensure that new risks are included in the Risk Assessment matrix and that old risks are re-assessed for possible changes.
This is actually required by API Specification Q1 9th Edition or API Specification Q2, therefore it should be part of your MOC procedure.
While the API Specification Q1 9th Edition or API Specification Q2 do not necessarily specify that one should evaluate new risks during the Management Review, the ISO 27001 standard does specify that new threats or new vulnerabilities be considered during the Management Review to see if they present a risk. Perhaps this meeting is also an opportunity to have management agree on the treatment of any residual risk. Mireaux’s products and services encompass international standards ISO and API Consulting, Hands-On Training, Auditing, Document Control and implementation of Web QMS platform.

Based on our experience, risk assessment is an exercise that you want to do right the first time and every time, so you don’t end up having to activate your emergency or contingency plans.
While the results of your risk assessment may affect the content of the procedures, you don’t want to scare your employees, by subjecting them to a risk assessment session when they do not fully understand what a procedure should look like.
Basically we live in a changing world so risks and their impact should be regarded as changing also. The requirement is basically that for every MOC, the change be assessed to ensure you have considered any potential risks. While most of them may be already included as part of the MOC process, there may be other factors that could trigger this as well. I like this concept, because the reality is that Risk Assessment is largely under-performed. We specialize in assisting companies achieve international standards certifications, including ISO 9001, API Spec Q1, API Spec Q2, ISO 27001, ISO 14001, OHSAS 18001 and SEMS. As indicated above, these are “special circumstances,” so they may be uncommon, but your team needs to be aware of them. Using Management Review – when all management should be present – as an opportunity to evaluate new risks, is truly a value added effort.

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