Clause 7.10: Nonconforming work

What the clause asks for

Clause 7.10 requires a procedure for when any aspect of laboratory activities, or the results of that work, does not conform to the laboratory’s own procedures or to requirements agreed with the customer. The procedure ensures that:

• responsibilities and authorities for managing nonconforming work are defined,
• actions, including halting or repeating work and withholding reports, are based on the risk levels the laboratory has established,
• the significance of the nonconforming work is evaluated, including an impact analysis on previous results,
• a decision is taken on the acceptability of the work,
• where necessary, the customer is notified and work is recalled,
• responsibility for authorizing resumption of work is defined.

Records of nonconforming work and the actions taken are kept (7.10.2). Where the evaluation shows the work could recur, or there is doubt about the conformity of the laboratory’s operations, corrective action under 8.7 follows (7.10.3).

What assessors sample

Assessors look at how nonconforming work is identified in practice: from complaints, PT results, equipment found out of tolerance, audit findings and staff observations. They read a few records end to end. Common findings:

• An equipment item found out of tolerance with no look-back at results produced since its last good calibration.
• No record of whether the customer was told.
• A nonconformity closed without deciding whether corrective action was needed.

Where this lives in AccreditBook

Requirement	Field in AccreditBook
Identification and source	NCR number, source (internal audit, external assessment, PT result, complaint, equipment, process, other) and a link to the source record
Description and immediate action	Description, immediate action, raised on, raised by
Significance and impact (7.10.1 c)	Risk level (low, medium, high), work affected
Customer notification (7.10.1 e)	Customer notified (yes or no)
Decision to take corrective action (7.10.3)	Corrective actions table on the same record

A nonconformity moves through open, investigation, action planned, action in progress, verification and closed. It cannot be closed until at least one corrective action is completed and its effectiveness check is recorded as effective, so the 7.10 to 8.7 handover is never skipped silently. Every change is in the record’s Activity tab.

See Nonconformities, Corrective actions and Clause 8.7.