As we live in a changing world, it comes as no surprise ISO 9001:2008 is now obsolete. One of the key revisions is to institute a systematic approach to analyze risk. What is risk? Risk is the extent of a potential failure of the unknown and/or the likelihood of its occurrence. Risk is native in all characteristics of a Quality Management System (QMS). Risk based thinking ensures risks are considered and controlled.
To ensure we are meeting requirements and needs of our customers and external agencies, Bull Metal Products needs to develop a concept of preventive action through risk assessment and mitigation. Failure Mode Effects Analysis (FMEA) will help identify risks resulting from changes in process variables. From product design to the manufacturing process, FMEA’s will help understand requirements (and changes to requirements) with clear vision for troubleshooting in the event of an internal or external product failure.
What is a Failure Mode? The indicator of a failure caused by product or process error (what happened and how did it happen?)
What is Affect Analysis? Identifying and addressing potential failures of production before they occur.
How can I eliminate risk?
Example: I can eliminate risk of being late for work by driving over the speed limit.
How do I mitigate risk?
Example: I can get to work on time but there is a good likelihood I could get pulled over by the highway police.
Implement a plan or action:
Example: If I wake up earlier, I will not have the likelihood of being late or getting pulled over.
Check the plan or action’s effectiveness:
Example: I woke up 30 minutes earlier and arrived to work safely (without getting pulled over) and on time.
Learn and Improve:
Example: I’ve been able to make it to work on time for an entire month. I know have data to use to help allow myself to make it to other venues and arrangements without being late. This experience teaches me to allow myself enough time for transportation incase an unknown variable could delay my travels.
Implementing control where the identified variables may be unknown is essentially incorporating Preventive Action throughout the entire context of the organization, including external parties. Risk based thinking is not new. We ask ourselves these types of questions in everyday life. Implementing risk mitigation to our QMS will allow us to meet the new standards of ISO 9001:2015 while being able to serve our customers with better products and services.