ISO 2015: Risk? What risk?
The 2015 revision has eliminated Preventive Action. Actually, it has really been repurposed and branded as “Risk”. Most companies are typically doing risk management but not calling it risk (quoting, contract review, pFMEAs, etc.). The objective of the new emphasis on risk is to have companies address uncertainty in processes that will affect the quality of the customer’s delivered goods or services. As with preventive action, things such as trends, history and customer feedback will be drivers of risk mitigation.
Under 2015, risk-based thinking (RBT) permeates every facet of the company with the expectation that you look at everything with a “risk-based eye” (what can go wrong and what do we do if it does). When addressing risk in your Quality Management System, be sure that you look beyond simply determining the “chance” that something happens and evaluate “the effect of an uncertainty” on your business and QMS objectives.
There are five (5) attributes to enhance risk management:
- A company should accept accountability for their risks and develop comprehensive controls and risk mitigation strategies.
- Risk management should be a part of a company’s continuous improvement strategy.
- Identify and train individuals with accountability for risk management.
- Decision making within the company should include consideration of risks and the application of the risk management process where appropriate.
- Maintain consistent and periodic reporting to all stakeholders of the company’s risk management performance.
In the real world, we all know that extensive analysis and identification of high risk orders will not prevent the president from overriding it and saying “I understand, but we are taking this order!” That is fine, the intent of the standard is that you go into everything with your “eyes wide open” by acknowledging, and consciously accepting any risk (hopefully with additional countermeasures put in place to minimize it).
Contact me to see how I can help you implement risk-based thinking as painlessly as possible in your company.
920-841-3478
Steve@TheRightApproachConsulting.com