Risk Management Part 5 – Subjects to Consider

The ISO 9001:2015 standard requires consideration of issues regarding the pertinent requirements of the relevant concerned parties to the Organization’s Context and identification of risks and opportunities that need to be addressed in order to:

a) Ensure that the Quality Management System can achieve its intended results
b) Increase the desirable effects
c) Prevent or reduce undesirable effects
d) Achieve improvement


When we perform a Risk Analysis, the issues are those unexpected exits in any of the processes of the Quality Management System, which may be favorable (opportunities) or unfavorable (risks) for the performance of the process. In the Failure Mode and Effects Analysis (FMEA) vocabulary, the issues are known as Failure Modes. Here are some examples related to the production process:


Process of SGC: Production

Favorable Issues: Little variation in production processes, available production capacity, pleasant working environment, use of state-of-the-art technology, etc.

Unfavorable Issues: Non-compliance with product specifications, late delivery dates, high production costs, regulatory non-compliance, frequent accidents in work areas, etc.


During the Risk Analysis, the Unfavourable Issues to consider can be determined from:

  1. Customer complaints – Non-conforming departures from the past that reached the customer
  2. Internal process rejections – Non-conforming outputs from the past that could have been contained by the same process
  3. Similar processes – Non-conforming outputs from the past that have occurred in other processes, products, etc.
  4. Assumptions – Potential outings that have never occurred but are thought to occur


IATF16949:2016 requires that at least the following Issues be considered:

  • Lessons learned from product recalls
  • Product audits
  • Field returns
  • Field repairs in the market (field repairs)
  • Complaints (complaints)
  • Scrap
  • Reprocessing (rework)


In the same way, favorable Issues can be determined from:

  1. Customer acknowledgements, awards, etc.
  2. Internal best practices, innovation and improvement
  3. Benchmark, industry best practices
  4. Assumptions


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