An audit of a manufacturing process is a comprehensive examination of the process to verify that it is performing as intended. Processes generate results, and manufacturing process audits determine if the results are accurate and being generated by an effectively managed process. Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
Select a process to be audited. Prioritize the processes that can be audited in terms of importance and risk to the overall operation. Begin auditing the highest-risk areas first.
Select a team to conduct the audit. The audit team should be familiar with the process being audited. They should also be familiar with audit techniques such as sampling and analyzing results. They must have the necessary expertise to identify problems and determine the corrective actions needed.
Decide how often the process should be observed (the frequency of the audit). If there are significant problems or noncompliance, the process should be observed more often until the situation is under control.
Announce the audit in advance so there are no surprises. The objective is to improve the process, which will require the cooperation of everyone involved.
Set up an audit schedule for the entire shift and follow the established audit schedule. The number of observations will be your sample of the work for that shift. The audit schedule should be determined in advance and should be as random as possible. Once established, the audit schedule should be followed to provide results based on a random sample.
Document any problems discovered and inform all those affected. The idea is not to assign blame but to find a solution. The problems discovered become the basis for corrective actions and follow-up. Everyone affected by the problem should be informed so they are aware and can provide input to the resolution. Also, the process being audited will likely affect other processes in the over-all operation.
Determine and perform corrective actions. Let employees make suggestions for corrective actions and select any that are appropriate, but management should make the final decision as to which corrective actions to implement.
Monitor corrective-action results. Perform follow-up monitoring to determine if the corrective actions have actually eliminated the problem or if further action is required. Also verify that no new problems have developed or entered into the process.