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

[Kronos147]

One thing to remember about ISO 9001 is the writers were not thinking about the readers a whole bunch.

Risk and Opportunities is not a 'chapter' or single clause in the standard, rather it is a thread. Perhaps reading these clauses in order can help clarify the concept to some:

0.3.3 Risk-based Thinking
0.1 General
4.4.1 (f) AQMS and its Processes
5.1.2 (b) Customer Focus
6.1.1, 6.1.2 Planning: Actions to Address Risks and Opportunities
8.1.4 Prevention of Counterfeit Parts
8.3.3 (e) Design and Development Inputs
8.3.6 (d) Design and Development Changes
8.4.2 Type and Extent of Control
9.3.1 (e) Management Review: General
10.2.1 Nonconformity and Corrective Action
A.4 Risk-based Thinking

 

[hogheavenfarm]

I can understand Mikes examples, mostly opportunities that may be available in processing, but cannot wrap my head around Jens example of the Post its, as that is more of a strategic business direction thing, and most of us do not have access to that part of the business. I have no idea what my company may be exploring or thinking about, I do know what we are making and maybe can improve the process a bit.

 

[Jen Kirley]

I can understand Mikes examples, mostly opportunities that may be available in processing, but cannot wrap my head around Jens example of the Post its, as that is more of a strategic business direction thing, and most of us do not have access to that part of the business.

That is true, that's why top management is expected to be more aware of the QMS requirements and more actively involved. The language in the 2015 version reflects the effort to turn ISO 9001 into a business standard, not just a quality control standard. Chances are good that top management is already doing all this, they just haven't shared it with you before. I know that as a internal auditor I used to be denied any contact with the Annual Operating Plan.

I have no idea what my company may be exploring or thinking about, I do know what we are making and maybe can improve the process a bit.

Up to this point, we didn't have access to a number of strategic things that generally appear in business plans: internal and external issues, internal and external interested parties, related risks and what they are doing about them. That sort of thing used to be walled off from quality people. It was only talked about in "Mahogany Row." Part of the revision is to remove the silos walling off business interests from QC.

 

[Jen Kirley]

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.

That's great for Quality Assurance/QC. Now managers have to learn to do it way up there in the business planning stage.

 

[Zearl]

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.

Definition of risk: the negative effect of uncertainty

Definition of opportunity: the positive effect of uncertainty.

In my view, that is how it should be defined. Risk in the real world is only associated with negative effects. TC176 defined it as both negative and positive and that is simply not how it is defined and understood in the normal world.

Question: Can I define risk and opportunities as my view if it will help. Since the definition will probably be changed in the future? Risk should only be associated with the negative, and opportunities with the positive. While ISO 9000:2015 is stated as a normative reference in 9001:2015, it isn't really mandatory is it? Opportunities is not even defined in 9000:2015. Why?

My view is if defined as I believe it should be, it doesn't really contradict the intent or definition anyway, it just helps users understand the context.

Now you strict CB auditor's can jump on me!!

 

[howste]

Question: Can I define risk and opportunities as my view if it will help. Since the definition will probably be changed in the future? Risk should only be associated with the negative, and opportunities with the positive. While ISO 9000:2015 is stated as a normative reference in 9001:2015, it isn't really mandatory is it?

In ISO 9001:2015 Annex B it says that ISO 9000 "provides an essential background for the proper understanding and implementation" of ISO 9001. ISO 9001 clause 2 says that ISO 9000:2015 is "indispensable for its application." That sounds mandatory to me. However, what you do in your company to help them understand the intent and meaning is up to you.

Opportunities is not even defined in 9000:2015. Why?

I don't know why it's not defined in 9000. However, the ISO 9000 introduction has this note:

NOTE Guidance on some additional frequently-used words in the QMS standards developed by ISO/TC 176, and which have an identified dictionary meaning, is provided in a glossary available at: http://www.iso.org/iso/03_terminology_used_in_iso_9000_family.pdf

If you look in that document it says (item 73) that opportunity means chance. Unfortunately that doesn't add much clarity.

My view is if defined as I believe it should be, it doesn't really contradict the intent or definition anyway, it just helps users understand the context.

I like your definition. I agree that it doesn't conflict with the intent and it makes it more user friendly.

 

[Zearl]

In ISO 9001:2015 Annex B it says that ISO 9000 "provides an essential background for the proper understanding and implementation" of ISO 9001. ISO 9001 clause 2 says that ISO 9000:2015 is "indispensable for its application." That sounds mandatory to me. However, what you do in your company to help them understand the intent and meaning is up to you.


I don't know why it's not defined in 9000. However, the ISO 9000 introduction has this note:
If you look in that document it says (item 73) that opportunity means chance. Unfortunately that doesn't add much clarity.


I like your definition. I agree that it doesn't conflict with the intent and it makes it more user friendly.

howste,
Appreciate the response and thanks!
I guess I'll quote the 9000:2015 definition, but add some remarks in parenthesis to (think of risk as a negative effect and opportunities as positive effects).

 

[Antonio Vieira]

Considering the classical definition of quality, which can be easily stated as “assure customer satisfaction”, this standard has ZERO value!
And with the constant decrease in the number of 9001 registered organizations, since the beginning of 2015 version, is it to expect that this version will last the typical 7 or 8 years?

 

[hogheavenfarm]

I agree, I see this standard losing out as well, and mostly from a different perspective. Many of our customers have acted as if 9001 was not enough, and proceeded to add additional requirements on it. 9001 used to be good enough for IRIS, with a few simple addons, now its a nonstarter. The same seems to be true in the other standards. There is a revolt against the fuzziness of 9001:2015 and a subsequent substitution of a proscriptive set of 'best practices'. Sort of a return to the "old ISO 9001". I used to place some trust in a supplier that was registered, but no longer, now I audit them myself.

 

[John C. Abnet]

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.

Good day-
In applying the SWOT methodology, you may find this helpful. Think of Strengths and Weakness as traits INTERNAL to your organization and Opportunities and Threats as coming from OUTSIDE of your organization.

Using your data you may find...
1- You have very few problem recurrences. Therefore an internal Strength ("S") would be effective corrective actions).
2- You have numerous nonconformances due to lack of change point control. Therefore, an internal Weakness ("W") would be change point control.
3- You may be only selling your products to a single market, therefore, international or other industries may be an outside Opportunity ("O") to increase market share.
4- You may have a patent expiring soon, therefore an outside Risk ("R") may be competition.

Hope this helps.