Who will identify the issues (External, Internal and Parties (Stakeholder,Employee) [Management]

1) Who will identify the issues(External, Internal and Stakeholder) and how are they related to Quality objective?

2) Under External and Internal issue I have mentioned the Issue type as Technological and its impact to the organization and the Risks involved for the same. Here I have a doubt, does the issue description and Risk Description are the same . If yes please clarify?

 

Anil, ideally your top management should know/identify the external/internal issues. However since we should look at the issues as relevant to the quality management system, you as the quality professional may also be aware of these. So let us look at them, for example ,for a company manufacturing and selling products to their customers directly. So what are the issues relevant to the objective of QMS? Example:

1. Typically, to satisfy the customers by meeting their requirements as projected in their orders.
2. To do this you need reliable suppliers who should meet your quality and delivery needs to enable you to produce and supply to your customers.
3. If your product is mandated to meet certain regulatory requirements (e.g safety), put that also in
4. Your infrastructure for achieving your objectives must be available in good condition all the time
5. The manpower you need, to achieve the desired results, must be adequately skilled and motivated.

The first 3 are the examples of external issues; last 2 are internal issues. If any of these issues are not met satisfactorily, what is going to happen to your QMS or to your organisation itself? (what are the risks?)

Of course all these may need to be modified and added to, depending upon the nature of products and services you are dealing with and the size of your organisation.
Once you have listed these out you can discuss with your top management, or in a larger meeting, again, depending on your organization.

Hope this helps answer your question.

 

Context of the organization (3.2.2 of ISO 9000:2015) is defined as "combination of internal and external issues that can have an effect on an organization’s approach to developing and achieving its objectives". This would mean that prior to setting appropriate objectives, an organization should determine the relevant internal/external issues. For example if a pizza delivery service would like to set an objective like "Zero Late Delivery", they will need to consider internal issues like adequacy of motorcycle riders, maintenance of delivery motorcycles, communication infrastructure, timeliness of cooking/preparation, etc. and external issues like coverage of delivery zone, location of callers, traffic flow, weather conditions, volume of dine-in customers, etc.

 

Perhaps it is best not to start with the 'who is responsible?' question but have a look at what is already being carried out within the organisation. You may find that there are already processes in place, for example:

• Marketing looking at existing and new customers to see what their requirements are
• Design group looking at relevant new technologies that can be incorporated in products and services in the future
• Design and / or legal looking at upcoming legislation that may affect products / services
• Legal / Sales looking at upcoming changes to consumer protection legislation that can affect sales processes
• Top management looking at business strategy and predicted changes to the market
• Etc.

Once you've looked at wht is there you may immediately see there are owners of these processes and, working with the top team, agree how these might influence the organisation's processes, plans and objectives.

It sounds like you are using PESTLE analysis to help identify issues that can influence the organisation.

Taking the Technology example you can have the same heading for internal and external interested parties but the issue for each is likely to be very different. So, as for the example above, there may be a technology development that influences the products / service you provide. E.g. Internet of Things - may mean that all products have to be designed with connection to the internet in mind and that brings opportunities and risks as my recent article highlights. Technology advances may mean that the quality management system can be made available as a portal at people's workplace rather than as hard copy documents.

Hope this helps.