What Is A Manufacturing Process Audit

Manufacturing process audits are a  type of quality assurance. It is performed to ensure that manufacturing processes are per the company’s quality standards. This audit process also aims to identify non-conformances and correct them before they cause problems downstream in the manufacturing process. 

It’s a procedure that can assess any manufacturing process, from simple batch line processes to complex multi-step processes. However, it focuses on one process at a time and asses the entire manufacturing process. 

What’s The Purpose Of A Manufacturing Process Audit?

As stated earlier, a manufacturing process audits is a standard step-by-step activity used to check compliance with the constant changes in normal operation expectations and conditions. It can take essential checklist completion or cross-functional deep dives into specific processes. It makes manufacturing audits important as they ensure the product is of quality standards. It also helps you identify potential problems that may happen during the manufacturing process and correct them to avoid defectiveness in the final product. In the case of non-conformances, they are usually classified, documented, and aggregated during audits. It ensures that manufacturing processes run efficiently and smoothly and comply with regulatory requirements. With that said, here are some of the benefits of  process audit;

  • It ensures that products are manufactured and adhere to company quality standards
  • evaluates industrial management skills
  • It helps identify potential manufacturing process problems so  they can have adequate cause if the action before they cause defects in the finished product
  •  It provides an overview of the company’s operations,  processes,  and workflows
  • It ensures that manufacturing processes run smoothly and efficiently at any stage 
  • It ensures there’s compliance with regulatory requirements
  • Helps improve overall manufacturing productivity
  • determines if the company’s production facilities are suitable for producing your product.

Steps Involved In The Manufacturing Audit Process

An audit of a manufacturing process is a comprehensive procedure; it’s performed to verify that it is functioning and conforms to adherence to standards in product quality. For this reason, it was correctly followed for accurate results and the quick correction of identified problems for consistency in the production process. Here’s is how the process audit is conducted;

  • Selecting A Process To Be Audited

First, prioritize the processes that can be audited based on risk and importance to the overall operation. It’s highly effective to start auditing areas with the highest risk.

  • Selecting A Manufacturing Process Audit Team

Select a team that will conduct the audit. It should be familiar with the audited process and equipped with audit techniques such as sampling and analyzing results. They should also have the necessary expertise to identify problems and quickly strategize corrective solutions.

  • Determining The Audit Frequency 

How often is the process to be observed? If there is noncompliance or significant problems,  the process should be followed more often to control the situation.

  • Announcement Of  The Manufacturing Process Audit

Announce the audit in advance to create awareness of the audit process. It will help to improve the process, which requires a high level of cooperation from the people involved.

  • Creating A Schedule For Manufacturing Process Audit 

An audit schedule is set up for the entire process, followed by the established audit schedule. The number of observations provides a sample of the work for that shift. The audit schedule is determined in advance randomly. Once established, it is followed to provide results from a random sample.

  • Documentation Of Problems Discovered In The Audit

Any problems discovered are documented and their effects. This step aims to find a solution as the problems discovered form a baseline to implement the effective cause of actions and follow-up.

  • Implementing Effective Solutions

Corrective actions are determined and implemented from the identified problems. Manufacturing process audit experts help management should make the final decision as to which steps to execute.

  • Follow-Up Monitoring

Implemented solutions are always followed to determine if they have eliminated the problem or if further action is required. It also helps to verify that no new issues have developed.


With manufacturing process audits, companies can keep up with the constant changes in manufacturing stages to ensure everything adheres to routine operating conditions, quality standards, and expectations. Since there’s much going into the auditing process, a checklist is an effective tool for ensuring every audit process is thorough.