• PQA International

Adding Depth to Process Audits

Large manufacturers like automotive companies continue to recall products, impacting customers, dealerships, and the reputation of the brand. Defective products come from weak or incorrect processes, or process controls. QMS audits are supposed to unearth those, before they result in defective products, but not if the audit contains questions like “Do you have a process? Do you follow it?” (Yep, we’ve seen those!!) Can we strengthen audits to validate processes, resulting in defect-free outputs?

Process audits help: for instance, combining an audit of vendor qualification, purchasing, receiving inspection, inventory, traceability, and control of NCP into a “Materials Management” process. Rather than looking separately at each of those, we trace an action (usually a job) throughout the chain, which not only checks each step, but looks possible gaps between steps.

LPA’s – Layered Process Audits – are even stronger. The “layers” refer to the organization, so an audit of Materials Management might involve the ISO auditor, plus machine operators, the line lead, and a manager. Yes, that’s a lot of personnel, which gets expensive, but so is a customer reject, or worse, a recall. Also, the team looking at the same device or activity will each see it from their own perspective, reducing the chance of weakness in a process or device slipping through.

Does every process in the organization need the same depth? Not really, so LPA’s should be chosen carefully. The most critical factors like calibration of production or measurement devices, aging of compounds or ingredients, adherence to standard work specifications, changes in customer specifications, or training for new or upskilled employees, may need the most attention. Points at which human assessment and judgment are involved may be more important than a step controlled by your ERP’s software.

When a layered team audits something, the persons audited gain a greater sense of top management’s commitment to quality, which can add to their appreciation of the importance of their contribution and a carefulness to ensure they are doing their best.

Final thought: Is it time to rethink your audit schedule, process, personnel and timing?

Do you have questions? We may be able to help.