Reporting significant non-conformities is an integral part of continual process improvement. When performing an investigation into a non-conformity, it is important to remember that the goal is to examine and improve a process, not to immediately place blame on individuals.
Human error and faulty systems are expected to produce mistakes, so use the QMS and NCE management program to encourage learning from such mistakes and improve processes.
However, this does not mean that a laboratory should cultivate an environment that is exclusively “blame-free.” There needs to be a balance of safety and accountability. Reckless, malicious, or otherwise purposeful harmful behaviors that lead to NCEs are not to be tolerated. To achieve this balance, management must promote the open communication that is necessary to report and work through NCEs.
