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What are the most common manufacturing audit procedures?

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Manufacturing audits are essential for ensuring quality, compliance, and efficiency in your production processes. They help you identify and correct any issues that may affect your products, customers, or reputation. But what are the most common manufacturing audit procedures, and how can you prepare for them? In this article, we will cover six types of audits that you may encounter in your manufacturing business, and what they entail.

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Hemel MAHMUD

B.Sc. in Engineering| Merchandising & Sourcing specialist in H&M l Ex-Development & Industrialization Production Leader…

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Ziaul Haider

General Manager at Renata Limited
Alex Rapel

Lead Auditor Medical Devices

1 Process audits

Process audits focus on how you perform your manufacturing activities, from planning and design to execution and control. They evaluate whether you follow the best practices, standards, and regulations for your industry and market. Process audits also check if you have adequate documentation, training, and resources to support your processes. Process audits can help you improve your productivity, quality, and profitability by revealing any gaps or inefficiencies in your workflow.

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Ziaul Haider

General Manager at Renata Limited
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Most of these completed by the list up to number 6, so I'm adding my perspectives including those - 1. As a successful manufacturing company we need to be competitive by all means - (a) Productivity in process development (b) improvement in process development (c) annually or bianually capacity assessment, all these documented evidences should be verified by experience experts.

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2 Product audits

Product audits examine the quality and characteristics of your finished goods or intermediate components. They verify if your products meet the specifications, requirements, and expectations of your customers and stakeholders. Product audits also assess if your products comply with the relevant safety, environmental, and ethical standards. Product audits can help you enhance your customer satisfaction, loyalty, and retention by ensuring that you deliver consistent and reliable products.

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Alex Rapel

Lead Auditor Medical Devices
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In medical devices industry the examples of product audit can be unannounced audits by Notified Body, UL & CSA type audits, also unannounced, or onsite installation witnessing audits by certification body. Main focus of such product audits is match between electrical / biological safety critical components assembled in fact vs. those approved in electrical / biological safety test reports for audited product, match between actual content of labels and IFU vs. content approved by certification body / safety lab, production and storage areas work environment impact on product safety and production process safety critical elements - e.g., presence of electrical safety tests and test parameters to match those approved by certification body.

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3 System audits

System audits review the effectiveness and suitability of your quality management system (QMS). A QMS is a set of policies, procedures, and tools that you use to manage your quality objectives, processes, and outcomes. System audits measure how well you implement, maintain, and improve your QMS according to the international or industry-specific standards, such as ISO 9001 or AS9100. System audits can help you demonstrate your commitment to quality, achieve certification, and gain a competitive edge.

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4 Supplier audits

Supplier audits evaluate the performance and capability of your external vendors, contractors, or partners. They ensure that your suppliers meet your quality criteria, contractual obligations, and expectations. Supplier audits also monitor if your suppliers follow the applicable laws, regulations, and codes of conduct. Supplier audits can help you reduce your risks, costs, and liabilities by ensuring that you source from reliable and reputable suppliers.

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5 Internal audits

Internal audits are conducted by your own staff or a third-party auditor hired by you. They are usually done on a regular basis, according to a predefined schedule or plan. Internal audits help you check your compliance with your own policies, procedures, and standards, as well as the external ones. Internal audits also help you identify your strengths and weaknesses, and implement corrective and preventive actions.

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6 External audits

External audits are conducted by an independent auditor or a certification body. They are usually done on a request or a requirement from your customers, regulators, or certifiers. External audits help you validate your compliance with the external standards, regulations, and requirements that apply to your industry and market. External audits also help you obtain certification, accreditation, or recognition from the relevant authorities or organizations.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Hemel MAHMUD

B.Sc. in Engineering| Merchandising & Sourcing specialist in H&M l Ex-Development & Industrialization Production Leader in DECATHLON| Trainer| Ex-Product Engineer l Business enthusiast
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Apart from that I think which will be most important audit in the coming days is the Energy Efficiency for the manufacturing industry. Because the world is moving towards sustainability and to make this world a better place to live we need to be more focused on the energy consumption as the source is limited. So Evaluating energy usage in manufacturing operations and identifying opportunities for energy conservation and cost reduction could be the key scope for the industry.

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What are the most common manufacturing audit procedures?

1

2

3

4

5

6

7

1 Process audits

2 Product audits

3 System audits

4 Supplier audits

5 Internal audits

6 External audits

7 Here’s what else to consider

Manufacturing

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What are the most common manufacturing audit procedures?

1

2

3

4

5

6

7

1 Process audits

2 Product audits

3 System audits

4 Supplier audits

5 Internal audits

6 External audits

7 Here’s what else to consider

Manufacturing

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