Layered Process Audit Checklist For Manufacturing

Layered process audits help prevent product recalls, costly rework and damaged brand reputations. Internal audits conducted daily by shift supervisors and middle management using standard audit templates detect any inconsistencies with established norms.

Management needs confidence that their specific work procedures are being completed as planned, so let’s explore how implementing a layered process audit checklist in manufacturing can give them that assurance:

Identify the Team
Layered process audits (LPA) provide companies with a proactive method for overseeing production systems and minimizing defects, helping identify issues before they wreak havoc with customer satisfaction, costs, delivery or morale.

LPA teams consist of quality professionals from various departments and levels within a company, so team members have a clearer understanding of how their work affects the entire process and vice versa. It also encourages employee involvement while furthering a quality culture.

Implementing a process audit program is vital to any manufacturing business, yet its supporting processes and systems must also be evaluated carefully. Without appropriate tools to facilitate their management and execution, conducting these audits effectively may prove challenging. With an EQMS software such as cloud-based EQMS solutions such as these you can ensure product defects are captured promptly while automating scheduling reminders to increase employee access to audit reports in one central repository.

Identify the Layers
Layered process audits are an efficient quality improvement strategy for ensuring compliance with standards and processes during production. Unlike traditional audits or end of manufacture inspections, layered process audits can be completed by any employee in your plant who has received appropriate training; additionally, these audits can be co-ordinated and managed by any functional area within your business, including Quality.

Layer 1 begins with supervisors and team leads conducting daily factory floor checks on various processes, then progressing up through middle managers who conduct weekly audits before executives audit on an occasional or more frequent basis.

Success with layered process audits lies in getting everyone involved, and low-code software tools designed for manufacturing, quality and safety management will make creating these audits much simpler. Simply set up your workflow using these purpose-built tools that enables each level of your organization to conduct these layered audits at intervals that works for them – this could take as little as minutes!

Prepare the Audit Questions
Make sure that the audit questions are relevant and specific. A key objective of layered process audits is identifying non-conformances, which can be identified through asking appropriate questions. Furthermore, consistency across audits allows you to compare collected data.

Create an audit checklist that can be utilized by all members of the team. It should include clear guidelines to follow and encompass all aspects of whatever layer or layer sets being audited – for instance, in auditing manufacturing there might be several layers involved such as raw materials, production, packaging/distribution.

Once your audit questions are ready, it’s time to conduct the audit. Make sure your auditors have copies of the questionnaire to refer back to during their investigation and ensure there’s room for auditor judgment in their answers – this allows them to spot anything the checklist may miss.

Conduct the Audit
Layered audits can be an invaluable way to establish an enterprise-wide quality culture and encourage Total Employee Involvement (TEI). They’re also an effective way of pinpointing issues or nonconformances that might reduce product quality.

Layered process audits differ from scheduled management reviews or ISO clause audits in that employees from various hierarchical levels conduct them themselves. Each person at a different hierarchical level conducts a quick checklist-based inspection on specific processes or work cells at their level of the hierarchy hierarchy; typically daily internal audits are assigned to shift supervisors while weekly ISO checks by middle management and monthly QC checks by plant directors or upper-level managers are the norm for these audits.

Layered process audits enable more thorough inspection, quickly identifying issues and allowing managers to address them immediately. Furthermore, it demonstrates to all team members that quality is everyone’s responsibility. Layered process audits have traditionally been employed within automotive and aerospace industries but have now expanded into areas such as medical devices, pharma & biotech products, consumer packaged goods and hi-tech industries.