Managing concerns (or non-conformances) in the manufacturing processes is crucial to sustaining high levels of quality performance and the foundation for a continuous improvement plan.

Concerns need to be identified, allocated to the process owners and acted upon, not just in terms of immediate containment to prevent bad products from reaching the customer, but also in terms of corrective and preventative actions.

Naturally these actions take place over extended periods of time. Having a system to manage all the concerns, and the related actions is crucial to the robust management of non-conformances and a key to being able to make improvements.


You can use Concern & CAPA Management module of Shopfloor-OnlineTM Lifescience Edition to manage various problems that can arise, for example: non-conformities, isolated product, audit failures, to name a few. The module allows concerns to be recorded and managed through to resolution:

  • Record the concern as it arises in manufacturing. It can be recorded with useful traceability information e.g. product, defect, line, machine, nature of concern, detail, date, quantity affected, quantity received
  • Attach documents: e.g. photographs to aid with capturing the problem
  • Assign ownership to an individual to manage the concern, the system can automatically send emails to alert the owner and other relevant people
  • Workflow – manage the concern and change its status as it moves through the process
  • To the extent that the other modules of Shopfloor-OnlineTM Lifescience Edition have been used: automatically drill into information that is available. e.g. records of production runs; quality checks; materials used
  • Investigate the root cause of the problem, build up a library of root causes.
  • Create action plans to handle the concern. These can follow templates, for example containment actions; corrective actions; preventative actions
  • Assign the actions to different people within the organisation
  • Ensure all actions are closed before the concern can be closed
  • Track the progress of the concern and any associated actions
  • Track the age of each concern and with email alerts ensure all complaints are managed to a timely conclusion

When Used with Other Modules

When the Concern & CAPA Management module is used in conjunction with other modules of Shopfloor-OnlineTM Lifescience Edition the speed and ease of investigating concerns improves drastically. For example:

  • With the Job Tracking module you can immediately find the production run associated with the concern, to know the Production Order, manufactured date and time, production Line(s), shifts and crews
  • With the Quality module you have access to the results of all quality checks done (or not done!) on the production run
  • With the Traceability – Consumption module you can see what lots of materials were used in the process. If you have concerns about the material you can work back up the other way and immediately find all production runs that used the same material – even if you have not had concerns yet.
  • With the Build Traceability module, you can extend traceability down to serialised parts and see every step of the production process

The Concern & CAPA Management module complements the Customer Complaints and Supplier Complaints modules which have an external focus.


  • Standardise response to adverse events – enforce the process of concern management and corrective and preventative actions.
  • Convenience – attach documents, like photographs, makes access to information easier for everyone and accessible from anywhere.
  • History – develop a history of concerns to support continuous improvement activities: concerns can be analysed by all dimensions for example by product, defect, line, department, shift, crew.
  • Improve communication and workflow – automatically notifying the right people, promptly and escalating complaints that are not processed in a timely manner.
  • Visibility – increase the visibility of concerns in the organisation.
  • Observe recurrence – watch for reoccurring problems, have root causes been eliminated? Are they still causing problems? Was the preventative action successful?
  • Continuous improvement – Use the tool as a platform for developing continuous improvement.