Risk Based Thinking ISO 9001:2015 and FMEA
The newly published standards of ISO 9001:2015 state that companies should adopt “risk based thinking” as part of its strategy. The idea of understanding risk is not entirely new to most process or product designers. During the design stage of any product or process, we were all cautioned by our teachers or supervisors to always ask “How can this fail?” and to look for ways to mitigate the condition.
The ISO 9001:2015 revision makes “risk based thinking” more explicit and builds it into the whole management system
FMEA: A tool for Risk Based Thinking
One of the tools we can use to demonstrate that we use “risk based thinking” is Failure Modes and Effects Analysis. It is a systematic method and a documented process to: recognize, evaluate, and prioritize potential failures and their effects. It structures the procedure to identify the actions which could eliminate or reduce the chance of potential failure occurring.
Failure modes are the ways in which the systems, process, component, sub-assembly or product could fail to perform its intended function. Failure modes may be the result of upstream operations or may cause downstream operations to fail.
Failure effects are the outcomes that are due to the occurrence of the failure mode on the system, product, or process. It is the “IMPACT” on the customer.
Risk Priority Number (RPN)
FMEA uses the idea of a Risk Priority Number (RPN) to rank the order of importance we can place on risks that we have identified. This is a form of Pareto Analysis on the Risk that we have identified. The RPN is the product of severity x frequency x detectability. The failure mode with the highest RPN is ranked number one, the second highest as number two and so on. The results in a table which suggests that our improvement efforts should be concentrated on the failures modes with the highest rank.
When to conduct an FMEA
- When conducting a process or product improvement. Ideally this is done as early in the program as possible.
- When new systems, processes and products are being designed.
- When existing designs or processes are being changed.
- When existing designs are used in new or different applications.
Learning how to conduct an FMEA
We offer FMEA training in public and in-house seminars. RMP Consultancy has conducted FMEA training for many of the largest companies in the Philippines. Contact Chili or Francis now for more information.
FMEA, RCA, SPC, and 8D Seminar Outlines
Upcoming FMEA, Root Cause Analysis (RCA), and 8D Seminars
2 Oct 2019, Wednesday, Failure Modes and Effects Analysis FMEA Essentials (one day),
14 Oct 2019, Monday, Root Cause Analysis RCA Essentials (One Day Seminar),
15 Oct 2019, Tuesday, Focused Improvement: The 7 Quality Control Tools,
21 Nov 2019, Thursday, Focused Improvement: The 7 Quality Control Tools,
22 Nov 2019, Friday, Root Cause Analysis RCA Essentials (One Day Seminar),
25 Nov 2019, Monday, Failure Modes and Effects Analysis FMEA Essentials (one day),
Register for one of the Seminars Above
Register for the Seminar
RMP Consultancy Seminars are available in the following formats:
- Public Seminar at our training center in Quezon City Philippines
- In-House (at your site) Workshop Format for a Max of 25 pax (Recommended)
- Special Exclusive Run
- One-on-one Coaching
Please Call Marco or Claire:
Landlines: Tel (632) 697-0767, Tel (632) 579-0233
Mobile (Globe) 0917-882-5578, Mobile (Smart) 0920-918-7358
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