Coronavirus/Covid-19 Information & Updates for Manufacturers

Evaluating Your QMS Risk Management Plan – Pandemic Considerations


Companies who have ISO based certified Quality Management Systems such as ISO 9000, AS 9100 or IATF 13949 have analyzed the risks and opportunities associated with their businesses as part of the requirements for those standards. These same organizations need to ask themselves what the COVID-19 Pandemic has changed as far as their risks and opportunities.

These standards state “Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results, and preventing negative effects”. Additionally, the standard states “the organization shall … determine the risks and opportunities that need to be addressed to: enhance desirable effects; and prevent or reduce undesired effects”. It is important to remember that one of the requirements of ISO based system is the need to evaluate their risk management plan, typically, annually.

The pandemic has created additional risks which is certainly sufficient cause for reviewing and updating your company’s risk analysis immediately. You should not wait for the scheduled annual risk review and should plan on reviewing your company’s risk assessment by the end of the second quarter.

All companies are unique, but the following are some new risks that may be considered:

  • International sourcing
  • Sole sourcing
  • Interruptions to supply chain
  • Cross training – due to anticipated absenteeism
  • Illnesses due to virus (shop floor & key personnel)
  • No contact / communicating with remote workers (i.e. power outages or other causes)
  • Cyber security for remote work
  • Lead times (impacted by supply chain and employee availability)
  • Required layout changes (to maintain distancing)
  • Financial Risk – cash flow, drop in customer demand, canceled orders

A functional quality management system would need to consider these additional threats that are now addressing the organization and make appropriate changes to the priorities and actions planned.

On the flip side, opportunities may also be presenting themselves. Competitors may not be able to serve customers due to their own compromised situation. This can provide your organization opportunities for additional business that was not available earlier. The company should analyze these as well and take appropriate action based on the potential opportunities.

Given the uncertain situation we find ourselves in, companies with established quality management systems have the tools in place to minimize risk and maximize opportunities. If your organization is struggling how to best apply these tools contact Insyte Consulting for a discussion and assistance in identifying your best approach:


David Hanitz: 716-982-6406
Ryan Case: 716-864-4329