Episode 5: Seven Common QMS Questions #QualityMatters2.0
Managing a quality management system involves more than maintaining procedures and preparing for audits. Quality managers regularly face decisions about corrective actions, training records, supplier approval, and the level of documentation needed to maintain effective controls. In Episode 5, Kyle Chambers and Caleb Adcock address seven common QMS questions that arise in their work with clients. Quality professionals regularly face questions about corrective actions, training documentation, supplier approvals, and maintaining effective processes. In Episode 5, Kyle Chambers and Caleb Adcock address seven common QMS questions they frequently receive from clients.
The discussion begins with two related concerns: Does every nonconformity need a CAPA? and Can one CAPA address multiple audit findings? Not every nonconformity requires formal corrective action, as isolated issues may only require correction and documentation. However, recurring problems or identifiable trends may justify a more thorough investigation. Multiple findings can also be addressed through a single CAPA when they share a common root cause, provided the corrective action addresses the underlying problem and includes verification of its effectiveness.
The conversation then turns to employee competence and purchasing controls, beginning with Is a signed training sheet enough? A training record may demonstrate attendance or awareness, but technical responsibilities often require additional evidence of competence through testing, observation, or practical demonstrations. The appropriate documentation depends on the training's purpose and the employee's responsibilities. This distinction between documented approval and demonstrated capability also applies to Does an approved supplier mean an approved purchase? Supplier approval should establish the specific products or services a supplier is authorized to provide, rather than automatically approving every potential purchase. Transactions outside that scope may require additional evaluation, conditional approval, or documented exceptions to maintain appropriate purchasing controls.
Another common question involves document control: We revised the procedure. Have we fixed the problem? Updating a procedure does not necessarily resolve the original issue, particularly when affected employees have not been informed of the change or trained on their revised responsibilities. Kyle and Caleb explain why organizations should consider the impact of procedural changes, communicate revisions effectively, and confirm that the updated process is understood and implemented. Depending on the circumstances, significant changes may also require additional controls, such as formal corrective action or management of change. The discussion then addresses What should management review actually produce? Rather than serving as a meeting held solely to satisfy audit requirements, management reviews should result in documented decisions, assigned responsibilities, actionable improvements, and follow-up on previously established objectives.
The final question, What should the quality manager do between audits?, brings these topics together by emphasizing ongoing oversight rather than periodic preparation. Kyle and Caleb recommend maintaining a regular schedule for reviewing nonconformities, corrective actions, training records, calibration, maintenance, and supplier performance. They also highlight the importance of spending time on the production floor, communicating with employees, and identifying concerns before they develop into larger problems. Throughout the episode, the central message remains consistent: an effective quality management system should support daily operations without creating unnecessary administrative work. By maintaining practical controls, meaningful documentation, and consistent oversight, organizations can improve their processes throughout the year rather than waiting until the next audit.