From procedure to shop floor: verify the work as performed

Follow an activity through three views

Read the applicable instruction, observe the work and examine the resulting evidence. Each view answers a different question: what was intended, what happened and what can be demonstrated afterward. Agreement supports a conclusion; disagreement identifies where more investigation is needed.

This guide focuses on implementation. The related procedure-design guide addresses how responsibilities, triggers and criteria are written before the work begins.

A synthetic example: documents prepared after the event

Imagine an operator explaining that the team works from experience and the quality department organizes the paperwork later. That statement is an audit lead, not a finding by itself. Trace the actual instruction, relevant work order, inspection results and any abnormal condition.

The investigation might find unclear revision status, records without a batch reference or an anomaly handled verbally. Determine the applicable criterion and supporting evidence before concluding that a control failed.

Check the method at the point of use

Compare the revision applicable to the work with the instruction available at the workstation. Review how changes reached affected people and how obsolete information is prevented from unintended use. The newest document today may not be the revision applicable to an earlier sampled job.

Ask people to explain the control point and show how they perform it. Training attendance can support the investigation, but observation and relevant output help establish whether the instruction is understood and applied.

Follow the output and the exception

Trace the completed activity to a record with the relevant product or process reference, result and decision. Where authorization matters, establish who acted and when. Check whether the evidence is sufficient for the conclusion being drawn.

Then sample an exception: a failed inspection, expired equipment status or unclear instruction. Determine who was notified, what work was held, what decision was authorized and what evidence demonstrates the outcome.

Find the cause of the disagreement

When actual work differs from the procedure, establish whether the approved method remains suitable and meets the applicable requirements. The issue may involve access to information, an impractical instruction, competence, resources or supervision. Do not assume every difference is deliberate noncompliance.

Revise the method through the appropriate controls when necessary, communicate the change and verify implementation. Reissuing a document or repeating training without addressing the observed cause can leave the original gap intact.

Bring repeated gaps into management decisions

Use internal audits and process monitoring to identify recurrence. Where the issue crosses functions or requires resources, provide management with the evidence and the decision needed. Track both implementation and whether the gap has been reduced.

A useful review sequence is: applicable instruction → operator understanding → actual work → traceable record → exception handling → follow-up. Select samples that test important controls rather than only tidy files.

Related practice guides

• Why management review needs more than meeting minutes
• Why quarantined product can still escape
• First-piece inspection: evidence before production release
• Why more procedures do not guarantee audit conformity