Nonconforming Work, Corrective Action and Complaints Procedure

Purpose. Explains how any departure from procedures, methods, quality control limits or client requirements is recorded, evaluated, corrected and prevented from recurring, including client complaints.

1.What is a nonconformance

A nonconformance is any work, result or condition that does not meet the laboratory's procedures, the test method, the quality control acceptance criteria or the client's agreed requirements. Examples include a quality control sample outside limits, a holding time breach, an equipment check failure, a calculation or transcription error, a missed step in a method, an incorrect report and a client complaint. Any staff member who identifies a nonconformance must record it on the day.

2.Recording

Record the nonconformance in the nonconformance and corrective action register with the date, section, description, samples and reports affected, and the immediate action taken. Assign a reference number. If results have already been reported, the section manager must be told immediately so the client can be notified and the report withdrawn or amended.

3.Evaluation

The section manager evaluates the significance of the nonconformance, decides whether affected work is acceptable, must be repeated or must be withdrawn, and records the decision. Where the nonconformance could recur or affects the validity of results, a root cause analysis must be performed using a structured method such as the five whys or a cause and effect diagram, with the people involved.

• Determine the extent: which samples, batches and reports are affected
• Decide on acceptance, repeat or withdrawal
• Notify the client where a reported result is affected
• Identify the root cause

4.Corrective action

Corrective actions must address the root cause, not just the symptom, and be recorded with an owner and due date. Typical actions include retraining, method amendment, equipment repair, changes to worksheets or software checks. The Quality Manager monitors due dates and escalates overdue actions to the Laboratory Director.

5.Verification and closure

A nonconformance is closed only when the Quality Manager has verified that the corrective action is complete and effective, which usually means reviewing subsequent quality control data or audit findings. The closure date and evidence are recorded in the register.

6.Complaints

Complaints from clients or other parties are recorded in the register as a nonconformance of type Complaint and acknowledged to the complainant within two working days. The investigation is carried out by a person not involved in the original work where possible, and the complainant is informed of the outcome in writing.

7.Trend review

The Quality Manager analyses the register quarterly for trends by section, type and cause and presents the analysis at management review, with any preventive actions recommended.