ISO 9001:2015 - Definition of Opportunities (Per 6.1.1)

[jga444]

Per 6.1.1 - Actions for Risks and Opportunities

Can anyone give me a definition of an Opportunity. It is not defined in ISO9001 or 9000.

The ISO White Paper - Risk-Based Thinning in ISO 9001:2015 gives the following:

Risk is commonly understood to have only negative consequences; however the effects of risk can be either negative or positive.

In ISO 9001:2015 risks and opportunities are often cited together. Opportunity is not the positive side of risk.

An opportunity is a set of circumstances which makes it possible to do​

something. Taking or not taking an opportunity then presents different levels of risk.

At the operational level then, may I look at it this way:

Risk: The risk already exists in our operations and is identified, evaluated and mitigated by actions plans, if we decide to do so.

Opportunity: Circumstances allow us to do something new and beneficial. However, it may increase risks in certain areas, as the results. We would then have an opportunity for improvement buy mitigating the resulting risk by action plans.

Any input is appreciated.

 

[bigqman]

Re: ISO 9001:2015 - Opportunities

I utilize ISO 31000:2009 Risk Mgt Standard - - there is a "public" copy available online (unsure whether it is appropriate for me to post link!)

Concept of "risk treatment " in 2.25 may be of help - a process to modify risk that can involve taking or increasing risk in order to pursue an opportunity -AND - (this helped me a lot.....) It is important to identify risks associated with Not pursuing an opportunity! Hopefully some of this helps you!

 

[jga444]

Re: ISO 9001:2015 - Opportunities

Hi

It seems to me that to 'identify risks associated with Not pursuing an opportunity' is just mitigating a risk. Depends on were you start from. Why call it an opportunity when it can be considered a risk that may need to be managed.

 

[Randy]

You need to read the complete Standard, in this case 0.3.3 Risk-based thinking to help get an understanding of how opportunities can await you

 

[Sidney Vianna]

This discussion is very illustrative of the debacle created by some parts of 9001:2015.

The misdevelopment of the standard, moving further and further away from its original intent of providing sensible yet robust requirements for confidence building in b[sub]2[/sub]b contractual relationships, can turn into a disaster if not properly corrected.

Customers want assurance they will get what they ordered. Mind numbing mental exercises about risk apetite and opportunity management will only detract 9001 and it's users of what led the standard to be a global phenomena, welcome by the business community for almost 15 years. Sad to see the direction parts of the standard are leading people astray.

 

[Jen Kirley]

jga444, you have what you need but don't realize it.

Like Sidney said, this set of concepts have given ISO 9001 users plenty of reasons to feel unsure of themselves and the extent of their understanding. The terms have become less of a quality guru's technospeak and more in line with general business. That has QA people's heads spinning.

The 3M Post-it® Notes story provides an example of risks and opportunities:

1968, Dr. Spencer Silver, a 3M Company chemist, was doing R&D for a super-strong adhesive. He came up with a super-weak adhesive instead. (R&D always includes the risk of not coming up with what you want).

There was an opportunity for the super-weak adhesive, and Dr. Silver promoted its use within 3M for the next five years, but no one could think of a way to use it until a colleague became frustrated when the bookmarks he used to mark his place in his hymnal kept falling out. They tried some of Dr. Silver's super-weak glue on a book mark, with happy results.

Then comes the risk of successfully launching a new product. In 1977 (nine years after the adhesive was invented!) 3M launched the product under the name “Press 'n Peel" in 1977 in four cities. It was not an immediate success. Then, a successful product test took place and the canary-yellow, renamed Post-it® Notes went nation-wide in 1980.

It is said that signature canary-yellow color was also an accident (an opportunity in disguise?): the 3M team that first developed the product used leftover scrap paper from a nearby laboratory for their successful product test that went ahead and launched one of the most ubiquitous forms of office material.

Maybe this is why the technical committee has included the SWOT (strengths-weaknesses-opportunities-threats) analysis as an example of risk-based thinking. The SWOT method is so well-known in business that its use can remove a barrier that previously existed between QA and top management in some organizations. The site I linked gives lots of examples for input that would do nicely as identifying internal and external issues...

I hope this helps!

 

[Sidney Vianna]

I hope this helps!

Jen, I know you posted that with the best of intentions; however, in my opinion, the 3M post-it notes example does not help at all for the typical ISO 9001 user organization.

It should go without saying that, in 1968 there was no ISO 9001.

The post it note is an example of creativity going right. A multi billion product line coming out from innovation. It has nothing to do with quality assurance.
This should have nothing to do with ISO 9001 in my opinion.

It is just a matter of time until misguided 3rd party auditors start writing nonconformities such as "there is no evidence available that organization X has identified opportunities". Pretty much akin when we had auditors writing up nonconformities for lack of "preventive actions".

The TC 176 SC2 WG24 created a potential quagmire for ISO 9001:2015 registrants with this opportunity bs, in my estimation. Once again, many uneducated registrants will be left at the whim of auditors on murky, undefined, non-QA related issues.

Chances are, and as in the past, most of the conformity assessment practitioners will blissfully ignore this aspect of ISO 9001:2015. Time will tell.

 

[Jen Kirley]

I suggest we move beyond product and recognize ISO 9001:2015 as an organizational document, as it was meant to be.

It's true that ISO 9001 did not exist in 1968. That wasn't the point; risks and opportunities exist in design and marketing too, both of which are arguably critical for even the best product to succeed. We are asked to recognized that an opportunity is not necessarily a carefree solution. It could present its own risks; we are asked to consider them. Organizations have been using the SWOT for a long time already. This is not a new thing. It's just new to the quality standard.

When output of processes is mentioned in the standard, we are talking about things including but also beyond production. Otherwise, the standard would have said production outputs instead. For organizations concerned about losing their skilled personnel in a wave of retirement, there is an opportunity to set up a mentorship program and/or work with area school(s) to tweak their curricula in order to help build skills for students who hope to join the organization. It's about the organization's issues, which may also involve support processes. The system.

It is important to not over-complicate these subjects.

 

[Mike S.]

Examples of opportunities:

Find a way to change a process to reduce its cycle time or waste.

Discover a way to make a measurement faster or more accurately.

Apply a new technology to your current product line to make it better/cheaper/faster (i.e. additive mfg. instead of machining parts out of bar stock).

Implement SPC to better control your process.

 

[bigqman]

Thank you Jen from someone of average intelligence and limited time:
X Resources;
Define and mitigate risks.
Define and take advantage of opportunities.
Actions taken effective?
Evidence?