Manufacturing Audit Checklist: A Closer Look

As a complex machine with numerous moving parts, manufacturing is an industry that relies on complete transparency to prevent small issues from turning into expensive fixes down the road.

Various types of audits (and their relevant checklists) serve the manufacturing industry, all of which play an important role in ensuring product quality control, compliance, efficiency, and cost-effectiveness.

More specifically, an audit is a structured evaluation of a wide range of production processes, quality management systems, and compliance with industry standards.

Learn how digital plant floor audits can save millions of dollars: The Digital Plant Floor Audits Business Case

Let’s take a closer look at what a manufacturing audit is, the process behind it, and what it should include.

What Is the Manufacturing Audit Process?

A manufacturing audit can be conducted internally or by a third party, and there may be some variation in the process depending on what type it is, but generally, the process is as follows:

Step 1: Choose the Type of Manufacturing or Factory Audit You Need

A manufacturing audit is a full-scope evaluation of a factory or manufacturing facility to ensure quality, efficiency, safety, and conformity with industry standards. Audits can be conducted internally or externally.

While we’re here, let’s take a look at various types of manufacturing audits:

Manufacturing Process Audits

A process audit evaluates specific manufacturing processes to ensure efficiency, consistency, and adherence to standard operating procedures (SOPs). Process audits evaluate equipment, workflows, and procedural best practices to identify potential waste reduction opportunities.

Layered process audits (LPAs) take a multi-layered approach to manufacturing process audit checklists, in which evaluations are carried out much more frequently and by multiple employees from every stage of the manufacturing process — from operators to executives. The purpose of an LPA is to catch small inefficiencies before they escalate.

Supplier Audits

These ensure that any external suppliers an organization works with meet its quality assurance, ethical, environmental and regulatory standards. Supplier audits are important in preventing supply chain risks such as inconsistent material quality or delivery delays.

Product Audit

This looks at whether a finished product (or even service) meets quality standards to ensure correct specifications, performance levels, and customer satisfaction and safety. For example, a product audit might check for defects and inconsistencies before products are shipped to avoid expensive recalls.

System Audit

A system audit is not technically a type of manufacturing audit, but they’re closely connected: The former assesses the organization’s quality management system (QMS), while the latter evaluates how well its manufacturing operations adhere to that system.

Compliance Audit

This evaluates if a company’s manufacturing processes are compliant with local and federal laws, policies, procedures, and regulatory guidelines. Since non-compliance can leave a company vulnerable to fines and reputational damage, these should be done regularly.

Here are some of the regulations and regulatory organizations that U.S. manufacturers have to adhere to:

AS9100
ISO 9001
Food and Drug Administration (FDA)
Securities and Exchange Commission (SEC)
Environmental Protection Agency (EPA)
Consumer Product Safety Commission (CPSC)
Occupational Safety and Health Act (OSHA)
Federal Motor Carrier Safety Administration (FMCSA)

Understanding the scope of the audit and your company’s objectives will give you a better idea of what standards your audits will be measured against and what resources you’ll need to conduct and complete an audit report.

Step 2: Prepare Your Checklists

Now that you know whether you’re talking about a manufacturing audit or a type of manufacturing audit, you will have to prepare your checklists. It’s important that your checklists are as thorough as possible so that nothing important goes unnoticed.

Depending on the type of audit you’re conducting, your checklist might have a list of yes or no questions, boxes to check off, or space to fill in full answers, and it might include space to leave photo evidence.

Once the checklists are prepared, your next step is to schedule the audit and notify the appropriate parties.

Step 3: Conduct Your Audit

It’s time to visit the factory floor to inspect and record your findings. Before you start, ensure that you have all the necessary documentation related to what you’re auditing, e.g., SOPs and regulatory requirements.

During this step, keep these best practices in mind:

Take photo proof of any non-conformances and annotate these photos well.
Write clear, succinct notes.
In cases of non-conformances, assign corrective measures in order of priority.
Consider taking advantage of plant floor audit software so you can use checklists on your mobile device or tablet.

Step 4: Document Your Findings

A manufacturing audit can cover many bases, so it’s important to document your findings about all aspects of production — its processes, employees, products, machinery, plant floor signage, etc. — and compile everything into a clear and actionable report.

When you consider that your report will serve as a historical record against which all future audits will be measured, it’s especially important to make sure that your documentation is as comprehensive as possible.

Step 5: Implement Corrective Actions

You should now take steps to improve issues that were discovered in the audit phase. Whether it’s product quality, plant-floor bottlenecks, or regulatory non-compliance, you can now develop a strategy to resolve these issues.

But first, you need to understand the reason behind these issues.

You may start with a root cause analysis — such as Ichikawa’s Fishbone Analysis or the 5 Whys Method — to determine the cause. Then, your team can develop corrective measures to solve the problem, both immediately and long term.

Example corrective actions might include:

Updating SOPs
Training employees on quality control and other requirements, or updating training documentation to fill previous gaps in training
Implementing better procedures for supplier qualification and material inspections
Implementing LPAs

Step 6: Follow Up With Another Audit

What was the impact of your corrective measures? How have they impacted your manufacturing processes or the quality of your final products? Conducting a follow-up audit can help evaluate the effectiveness of these measures, as well as offer new insights on further improvements that need to be made.

Get Started With Our Templates, Checklists, and More

You don’t have to create your own checklists from scratch. Use our templates to help you get started:

In short, a comprehensive manufacturing audit checklist is essential for identifying inefficiencies, ensuring compliance, and driving continuous improvement on the plant floor. With a solid list or template in hand, you’re well on your way to better quality and compliance.

Manufacturing Audit Checklist: A Closer Look at Your Manufacturing Processes