It’s important for laboratories to plan and take action to avoid or eliminate nonconformities to reduce waste and rework, improve efficiency, and enhance customer satisfaction.
Nonconformity is the non-fulfillment of a requirement. Nonconformity can occur because of a failure to follow procedure or a procedure not being fit for the intended purpose. When a nonconformity may occur or has occurred, the laboratory must take preventive and corrective action to address the nonconformity.
Nonconformity may be identified during day-to-day operations of a laboratory, internal audits of the management system and laboratory activities, management review, document reviews, customer or supplier audits, or external assessments by regulatory or accreditation bodies. Regardless of how the nonconformity was identified, ISO/IEC 17025:2017, clause 8.7.1.a, requires that the laboratory take action to control it and address the consequences.
The proactive approach of addressing risks and opportunities can reduce the overall nonconformities identified in the laboratory. Risk-based thinking identifies potential nonconformities and addresses them through corrective and preventive action prior to occurrence. The steps of the basic risk-based thinking process enable the identification of potential nonconformities, as well as implementation and monitoring of actions to address those potential nonconformities.
As I noted in opening, by planning and taking action to avoid or eliminate nonconformities, laboratories can reduce waste and rework, improve efficiency, and enhance customer satisfaction. Determining the cause of the nonconformity can assist in determining any action needed. Typical causes of nonconformities include but are not limited to poor communication, inadequate training, inappropriate quality control materials, and inaccurate documentation, such as record keeping or standard operating procedures.
Action to avoid or eliminate nonconformities should be proportionate to the potential impact on the validity of laboratory results (ISO/IEC 17025:2017, clause 8.5.3) and appropriate to the effects of the nonconformity (ISO/IEC 17025:2017, clause 8.7.2). If the cause of the nonconformity is not adequately or accurately identified, the actions planned and taken may not be effective in preventing the occurrence or recurrence of the nonconformity.
Monitoring and reviewing the action taken, whether proactive or reactive, ensures that the action was effective in avoiding or eliminating the identified nonconformity. Monitoring activities may include verification of effective controls, evaluation of lessons learned, evaluation of changes in external and internal contexts, and reviewing related emerging risks.
Effective action fosters continual improvement in the management system and laboratory activities. An effective nonconformity management program using risk-based thinking will not only assist the laboratory in eliminating nonconformity before it occurs, but also ensure that actions take for nonconformities are appropriate and effective.
Further guidance on corrective action and cause analysis can be found in GD 2701, Guidance on Corrective Action and Cause Analysis, and the accompanying presentation GD 2701.01. If you’re interested in learning more about risk-based thinking, ANAB offers online, self-paced training on Approaches to Risk-based Thinking in Laboratories.