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How to Identify the Risks and Opportunities required for QMS Processes?

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John Predmore

Trusted Information Resource
#2
Your leadership team should start with a list of problems that have already happened, or problems that nearly happened ("near-misses"), or problems that happened to someone else but could happen to you. You should add to the list the events or issues that potentially threaten your product quality or your business, that keep you awake at night. If you can elaborate what answers you are looking for, the user community here is very helpful.

The greatest value of the Risk Identification exercise is to recognize new Risks which are valid concerns which have not happened yet or the idea hasn't occurred to anyone. There are tools and frameworks for brainstorming risks, you could buy a book or browse the Internet for ideas, look up FMEA for example. For example, list all the important functions which must occur for your product or business to be successful, then think of scenarios where any one of those functions fail. If you take raw material delivery as an example function, a crucial shipment could arrive late, or a partial shipment, the material arrives damaged, or not what you ordered. The shipment arriving early could also be a problem, if these are perishable items and you have no place to store them. Once you identify Risks, you would prioritize the list, and think of countermeasures or contingencies to reduce the greatest risk items. But you only asked how to identify risks and opportunities.

A similar thought process could generate a list of potential Opportunities, and you would devise action plans to capitalize on opportunities or put your company in position to increase your benefit.
 

qualprod

Trusted Information Resource
#3
Your leadership team should start with a list of problems that have already happened, or problems that nearly happened ("near-misses"), or problems that happened to someone else but could happen to you. You should add to the list the events or issues that potentially threaten your product quality or your business, that keep you awake at night. If you can elaborate what answers you are looking for, the user community here is very helpful.

The greatest value of the Risk Identification exercise is to recognize new Risks which are valid concerns which have not happened yet or the idea hasn't occurred to anyone. There are tools and frameworks for brainstorming risks, you could buy a book or browse the Internet for ideas, look up FMEA for example. For example, list all the important functions which must occur for your product or business to be successful, then think of scenarios where any one of those functions fail. If you take raw material delivery as an example function, a crucial shipment could arrive late, or a partial shipment, the material arrives damaged, or not what you ordered. The shipment arriving early could also be a problem, if these are perishable items and you have no place to store them. Once you identify Risks, you would prioritize the list, and think of countermeasures or contingencies to reduce the greatest risk items. But you only asked how to identify risks and opportunities.

A similar thought process could generate a list of potential Opportunities, and you would devise action plans to capitalize on opportunities or put your company in position to increase your benefit.
But put special focus to risk and opportunities at strategic level,
This could emerge at defining 4.1 external and internal issues.
In this case John refers I think more to operational risks.
A risk and opportunities at strategical level could be:
Regulations changes in other countries (importing, tax,etc.), opportunity at discovering a potential customers arriving near you needing your products, both could impact your company positive or negative,
while operational could be that your supplier has not enough stock.
 
#4
how to Identify the Risks and Opportunities required for QMS Processes?
Risks and Opportunities as per 4.1 may be identified through the SWOT Analysis. SWOT (strengths, weaknesses, opportunities, and threats) analysis is a framework used to evaluate a company's competitive position and to develop strategic planning. SWOT analysis assesses internal and external factors, as well as current and future potential.
 

Kronos147

Trusted Information Resource
#6
Isn't a preventive action from the previous standard similar to a risk assessment and mitigation in the new standard?

Are the preventive actions records a good place to look?
 

Big Jim

Super Moderator
#7
Isn't a preventive action from the previous standard similar to a risk assessment and mitigation in the new standard?

Are the preventive actions records a good place to look?
Some companies have chosen to continue using Preventive Actions as their method of handling risk. Completely appropriate. Since most companies didn't really do a very good job with their Preventive Action program so this has not been a popular method of handling risk.
 

John Broomfield

Staff member
Super Moderator
#8
The problem with preventive action is triggering it.

Data-driven preventive action in time to prevent a potential nonconformity can work well provided the system is gathering and analyzing the right data at the right time.

So, you may find that data-driven preventive action needs to be supplemented by the preventive action that flows from the planning often found at the front end of a process and/or as a process that serves the whole system.
 

tony s

Information Seeker
Trusted Information Resource
#9
how to Identify the Risks and Opportunities required for QMS Processes?
At the operational level, risks and opportunities can be better identified if the "output/s" of a certain process is/are well established (see 4.4.1a). Risks prevent the process from producing the desired outputs while opportunities help the process to produce the desired output. For example:
Process = maintenance of equipment;
Output (expected) = equipment are kept in good running condition, speedy and reliable repairs;
Risks = inconsistent equipment inspection, technician not familiar with equipment, inadequate tools, lack/no spare parts,​
Opportunities = maintenance contract with the equipment vendor, renting of equipment instead of owning.

Addressing the risks and opportunities with appropriate actions will ensure the achievement of the outputs expected from the processes.
 

junior1505

Involved In Discussions
#10
Dear Duckdonald,
Well, you can start the process as under.
1. Identify and tabulate all your possible stakeholders.
2. Tabulate and determine the needs and expectations for these stakeholders.
3. What could be the possible issues both internal and external.
4. You arrive at some issues, which are then to be taken as risks, without which there is a possible non-conformity that could arise or may be a threat to your organisation/process/operation.
5. You denote the action plans for these with their scorings.
6. Analyse that if your action plans go well then what benefit you will get in total.
Thats all.....
 
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