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- Keshav Ram Singhal
Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Sunday, October 9, 2016




There may be various methods by which an organization can determine its risks and opportunities. My earlier article 'DETERMINING AND ADDRSSING RISKS AND OPPORTUNITIES' provides details of FEMA method, a commonly used method of risk identification and risk analysis.

ISO 9001:2015 QMS standard does not provide any specific procedure or method to determine risks and opportunities. It is for the organization to apply any procedure or method to determine risks and opportunities.

This article provides you a simple method by which, you can identify risks and opportunities associated with all functions and processes in the quality management system of your organization.

Top management of the organization should form a team of identified personnel, well versed with organization's processes and functions, with a coordinator to determine, monitor and review organization's risks and opportunities. The coordinator of the team should design a simple format for identification of risks and opportunities that should have following details:
- Process
- Department
- Risk/potential problem identified
- How critical is the risk/potential problem?
- Is risk acceptable or unacceptable?
- Proposed action to address the risk/potential problem (What should be done?)
- Opportunity identified with relevant details
- Proposed action to address the opportunity, so that it remains an opportunity and not turns to risk (What should be done?)
- Remark, if any

The above parameters are indicative. You can add a few more as per your needs. An illustrative example of the format designed for this purpose is shown in the below figure:

Suitable instructions should be issued to all process owners and department heads of the organization to fill the designed format and submit the same to the coordinator by a given date. For the first time, the management of the organization will set up a target date, but thereafter all process owners and department heads should report new identified risk or opportunity as soon as it comes to their notice. The coordinator of the team should collect relevant data, compile them, discuss with other team members through formal and informal meetings. He should make a summary of determined risks and opportunities with proposed actions and report the same to the top management. The top management of the organization should issue relevant guidelines and instructions within the organization, including department heads and process owners. This activity should not be a one-time activity. The top management and the coordinator need to take proactive active action regularly. Regular reviews (say quarterly or half-yearly) should be done and the author hopes that this simple method will be able to address the determined risks and opportunities in a proactive way.

A few examples of a few risks are mentioned in my earlier article. Here-in-below you will find a few examples about opportunities.


Opportunities lead to progress. Opportunities give assurance that the system can achieve its intended results. Opportunities enhance desirable effects. Opportunities prevent, or reduce, undesired effects. Opportunities achieve improvement.

Examples of opportunities

- NABL certified laboratory within the organization that provides verification and calibration services. Monitoring and measuring resources are verified and calibrated within the organization.
- Particular process is well defined and documented. Dealing person is well aware of the process.
- Learning from the past.
- Organization strives to implement 5-S Practice in the organization.
- Maintenance schedule is monitored and maintained.
- Process workers are trained and well-versed with the associated process.
- Organization provides complete engineering installation and commissioning service to customers.
- Organization provides after sales service support to its customers.
- Excellent team of work force.
- High standard of work culture.
- Use of information technology (IT)

- Keshav Ram Singhal

For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.
For details on 'Checklist for ISO 9001:2015 QMS', please CLICK HERE.

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