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5.2 Quality Policy ISO 9001

Why Use a Manufacturing Process Audit Checklist?

Manufacturing Process Audit Checklist

The purpose of a manufacturing process audit checklist is to provide a framework of questions to keep an auditor on track while performing their job. There has been some debate on the effectiveness of audit checklists, but there are clear benefits to using one in your auditing process.

Why Use a Manufacturing Process Audit Checklist? 

Audit checklists are useful tools that keep an auditor on task. Implementing a checklist in the audit process ensures that every audit is performed in a comprehensive and consistent manner, resulting in all of the information you require about your manufacturing process.

It is entirely possible to perform a process audit without the use of a checklist, but you may find that by having one, you will see better results from your audits. Read below to learn more about the benefits and potential drawbacks of using a manufacturing process audit checklist.

internal audit

Benefits of Using a Manufacturing Process Audit Checklist

Performing a manufacturing process audit is an important step in making sure that the process is performing efficiently and successfully. An internal audit will give you objective data to measure and compare with past audits so you can easily see what is going right and what is going wrong. Having a checklist during an audit can help out in a number of ways.

Ensure the Audit Is Comprehensive

When it comes to auditing any process in your business, there is a lot to check for. It can be difficult for anyone to remember every question they need to ask or every requirement they need to check. That's where a checklist comes in.

Armed with an audit checklist, the auditor is less likely to miss anything. They have a ready-to-go list of everything they need to ask, who they need to ask, and what parts of the process need to be checked. Having such a comprehensive list prevents any important factors of the audit from being missed.

All Audits Are Performed Consistently

It is likely that there isn't only one person performing your manufacturing process audits every single time. Even so, you want every audit to be done the same way so that all of the collected data can be compared easily to identify needed improvements.

An audit checklist ensures that no matter who is performing the audit, the same data will be collected each and every time. Aside from minor changes, the checklist should always remain primarily the same, which means all the same questions will be asked during the audit. You can use these checklists as a side-by-side comparison to clearly see how your process is performing.

Provide Evidence of an Audit

In most cases, process audits are a requirement for your business to meet a certain standard. It is also required that you have evidence that the audit was actually performed. Having a completed audit checklist filed away means you have the evidence on-hand whenever necessary.

internal audit

A manufacturing process audit checklist also provides objective evidence that your process is improving. Comparing the data collected gives you an easy way to show that you are always getting better. And if not, it pinpoints what you can do the get better in the long run so that quick corrective actions can be taken.

Help Plan for Future Audits

With all of the data collected in your checklist, you can use it to plan for the future. Every audit is bound to be a little different depending on the current needs of your system and the process that is being audited.

An audit checklist is a fantastic tool to integrate into your audit planning. You can use the information gathered from the audit to decide where more or less focus needs to be placed during the next audit. This will help make the most out of every single audit.

Drawbacks of Using an Audit Checklist

There are factors of checklists that can have the opposite effect of what you are trying to achieve. With careful planning and close attention, most of these issues can be avoided completely. If you want to get the most out of your audit checklist, it's best to keep these things in mind.

The Checklist Is Poorly Formed

Whether you are creating your audit checklist from scratch or building it off of a template, it could end up being inferior to your needs. Checklists that don't include everything that needs to be looked into aren't going to be a big help to your auditing process.

When you are drafting your checklist, it is crucial to be certain you include all of the necessary questions to audit your manufacturing process. You should also be sure that questions are not repeated in other ways as it could slow down the process.

If you are using a template, you have to spend the time to customize it to suit your needs. Leaving the checklist as a primarily generic sample is only going to hinder your process audit instead of helping it.

The Length of the Checklist Is Intimidating

For the people on the other side of the audit, a long list of questions could seem more like an interrogation. While you shouldn't shorten your checklist and risk losing out on important information, you should take steps to prepare employees for every audit.

Don't spring an audit on anyone. Let them know ahead of time when the audit is going to take place for the process they are involved in. Give them some insight on questions that may be asked and the appropriate way to respond. If they feel well prepared for the audit, they are less likely to be worried about the checklist.

The Auditor Relies Solely on the Checklist

While a process audit checklist is a useful tool for an auditor, it should not be the end all be all of their auditing knowledge. An audit checklist should not be an excuse to skip the planning of an audit. Just because you already have a list of questions doesn't mean you shouldn't be planning everything out.

Well trained auditors should use a combination of their expertise, judgment, and the checklist to run a successful process audit. They shouldn't put all of their faith in the checklist to guide them through, or they might miss something along the way.

Should You Use a Template for Your Audit Checklist?

Just like a manufacturing process audit checklist is a valuable tool, templates can be extremely useful as well. Drafting a full checklist from start to finish could take a lot more time and effort if done from scratch. Reading up on and listing out all of the requirements you should be checking off can be a daunting task.

When you use a well-made template to draw up your audit checklist, you know that everything you need is already included. Template creators spend their time listing out all of the requirements so that you don't have to. They also come with helpful instructions on how to customize the template to your business and how to use the checklist to collect data.

If you decide to use a template you should make sure to thoroughly review and customize it so that it's exactly what you need. Using something generic or only slightly changed could serve to only confuse an auditor rather than help them. You have to take care to make the template your own so that it benefits your business.

An Audit Checklist Gives You Support

Manufacturing process audits are a very involved part of a business. There is a lot that goes into auditing any process, and you don't want to have concerns about missing anything. A checklist can provide a strong support system for your audit.

Using a manufacturing process audit checklist aids in ensuring that every audit is thorough. Having a list of questions to refer to keeps the auditing process consistent and results in data that can be easily compared.

A checklist is just another tool on the path to continually improving your manufacturing process. With such a handy tool at your disposal, you can be certain you are getting the most out of every audit.

Don’t Try to Manage It All Alone!

Our ISO Auditors and Quality Manager Trainers have been in this industry for years, and since 2002 we’ve been providing thousands of small businesses and large corporations with the tools they need to get certified.

Instead of trying to create everything you need to follow this process from scratch, use ours. We have procedures, templates, checklists, process maps, forms and gap analysis tools to help you control your documented information without missing a single input or output.

Before you invest all the hours reinventing the wheel, before you spend countless dollars outsourcing the task — try our templates.

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iso 9001
ISO 9001

ISO 9001 Internal Audit ToolkitISO 9001 Internal Audit Toolkit

Everything you need to perform and manage internal audits for ISO 9001:2015.

Contents

The documents are used together as a cohesive system or available separately below.

All these templates are included in our Quality Manual Template.

chartChecklists

Procedures

  • Internal Auditing - view sample
  • Management Review
  • Corrective Action
  • Improvement

processProcess Maps

  • Internal Auditing Process Overview (turtle diagram)
  • Internal Auditing Process Map - view sample
  • Corrective Action Process Overview (turtle diagram)
  • Corrective Action Process Map
  • Management Review (turtle diagram)
  • Improvement (turtle diagram)
  • Management Review Process Map

Internal Audit ProgrammeInternal Audit Program

  • Process Matrix
  • Long-range Audit Program
  • Short-range Audit Program

Corrective Action TrackerCorrective Action Tool

  • MS Excel
  • Predefined data–entry fields to describe the issue
  • Categorize all issues, assign responsibility, initiate tasks
  • Root Cause Analysis (RCA) actions
  • Determine problem-solving methods based on risk
  • Track progress and close-out with the Corrective Action Plan

reportReports & Forms

  • Process Responsibility Matrix
  • Internal Audit Programme
  • Management Review Tool
  • Corrective Action Tool
  • Management Review Presentation
  • Internal Audit Plan
  • Internal Audit Report - view sample
  • Management Review Minutes
  • Corrective Action Report
  • A3 Action Plan
  • 5-Whys Worksheet
  • 8D Worksheet
  • Action Items Log
  • Improvement Activity Form
  • Process Assessment

chartCharts

  • Automated Charts & Graphs - view sample
  • Monitor status in real-time
  • Make issues highly visible

PresentationTraining

  • QMS Internal Auditor Training

guidanceQuestion Guidance

  • Guidance and suggestions for each audit question - view sample

guidanceGuidance

  • Internal Audit Guidance - view sample
  • Internal Audit Programme Guidance
  • Internal Audit Checklist Guidance
  • Corrective Action Guidance
  • Management System Guidance - view sample

Control of Internal Audits ProcedureISO 9001 Internal Auditing Procedure

The purpose of the Internal Audit Procedure is to define your organization’s process for undertaking QMS audits, process audits, and supplier and legislation audits in order to assess the effectiveness of the application of the quality management system and its compliance to ISO 9001:2015.

This procedure also defines the responsibilities for planning and conducting audits, reporting results and retaining associated records.

- view sample

Process MapsProcess Maps

  • Internal Auditing Process Overview (turtle diagram)
  • Internal Auditing Process Map

Reports & FormsReports & Forms

  • Internal Audit Plan
  • Internal Audit Report

ISO 9001 Internal Audit Checklist v2ISO 9001 Internal Audit Checklist

Use this audit checklist to determine the extent to which your quality management system conforms to ISO 9001 requirements by determining whether those requirements have been effectively implemented and maintained.

This template will help you assess the state of your existing management system and identify process weaknesses. It will also allow you to prioritize corrective action based on a targeted approach.

Contents

All ISO 9001 Checklists are included in our Internal Audit Toolkit and Quality Manual Template.

Master Internal Audit ChecklistMaster Internal Audit Checklist

This audit checklist comprises tables of the certifiable (‘shall’) requirements, from Section 4.0 to Section 10.0 of ISO 9001:2015, each required is phrased as a question.

305 Audit Questions - view sample

MS Excel

  • Context of the organization
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance Evaluation
  • Improvement

Easily evaluate process performance. Use the drop-menus to input audit findings, create interactive trend charts and develop improvement plans.

The answers will automatically populate and update the Results Carts, Process Report & Action Report.

Audit Results SummaryResult Charts

More than just a static checklist, we offer a practical and versatile solution for reporting and analyzing data and generating actionable insights.

  • Automated Charts - view sample
  • Conformity of the QMS to Requirements
  • Pareto Chart of the Most Frequent Root-causes to Address
  • Compliance Summary
  • Noncomformances
  • Entry Errors to Correct
  • Issues to Correct
  • Conformity to Requirements
  • Summary of Audit Results by Process
  • Requirements to Audit per Process
  • Improvement Action Summary

processProcess Report

Using filters and buttons, the Process Report allows you to summarize the processes and their audit results from the data collected in your audit checklist into a table for reporting or analysis purposes.

Action ReportAction Report

Allows you to summarize the root-causes and the corrective actions required for each process.

guidanceQuestion Guidance

  • Guidance and suggestions for each audit question - view sample

Supplier audit checklistSupplier Audit Checklist

The Supplier Audit Checklist evaluates the quality of a current or prospective supplier/vendor's processes, ensuring that key risks to your organization’s objectives are being controlled.

Use this checklist to streamline your supplier evaluation process, enhance risk management, and ensure high-quality standards across your supply chain.

Contents

  • Supplier Audit Checklist - view sample
  • Audit Finds Summary (automated charts) - view sample
  • Process Turtle Diagram
  • Instructions

Benefits

  • Enhanced Risk Management: Focuses on key risks, ensuring that major threats to your organization’s objectives are identified and controlled
  • Improved Supplier Quality: Provides a detailed evaluation of supplier processes, helping to ensure high-quality standards
  • Clear Communication: Uses a 'traffic light' system to visually communicate risk levels, making audit findings easy to understand
  • Data-Driven Decisions: Automated charts and summaries provide a clear overview of audit results, supporting informed decision-making
  • Streamlined Reporting: Simplifies the process of generating audit reports and management review documentation
  • Objective Scoring: Provides a consistent and objective method for scoring audit findings, ensuring fairness and transparency

This template is included in our Internal Audit Toolkit and Quality Manual Template.

chartSupplier Audit Checklist

  • 89 Questions - view sample
  • Evidence Required
  • What to look for
  • Score
  • Observations

  • Operational Control
  • Process Approach
  • Performance
  • Internal Auditing
  • Receiving Inspection
  • Improvement
  • Quality Planning
  • Design
  • Training and Competence
  • Control of Nonconforming Product
  • Part Approval
  • Management Responsibility

The answers will automatically populate and update the Audit Finding Summary and charts.

chartAudit Finding Summary

  • Automated Charts - view sample
  • Compliance Summary
  • OFIs by Section
  • Recommendations

processProcess Maps

  • Process Turtle Diagram

Supplier Self-Evaluation AuditSupplier Self-Evaluation Audit

The Supplier Self-Evaluation Audit is a comprehensive questionnaire designed for current or prospective suppliers to complete. It helps you evaluate their quality assurance capabilities.

This self-evaluation tool ensures that suppliers meet your organization’s standards before procurement decisions are made.

Contents

  • Self-evaluation Questionnaire - view sample
  • Self-evaluation Summary (automated charts) - view sample
  • Instructions

Benefits

  • Enhanced Risk Management: Identifies potential risks in supplier processes, allowing for proactive issue resolution before procurement decisions are made
  • Improved Compliance: Ensures suppliers meet ISO standards, reducing the risk of non-compliance and associated penalties
  • Informed Decision-Making: Supports procurement decisions with detailed data and automated summaries, ensuring you select suppliers that meet your quality standards
  • Stakeholder Assurance: Demonstrates a rigorous and consistent approach to supplier evaluation, building trust and confidence among stakeholders

This template is included in our Internal Audit Toolkit and Quality Manual Template.

checklistSelf-Evaluation Questionnaire

64 Questions - view sample

  • Manufacturing
  • Receiving Inspection
  • Quality System
  • Measuring and Test Equipment
  • Nonconforming Product
  • Production Process
  • Inspections

The answers will automatically populate and update the Self-Evaluation Summary and charts.

chartSelf-Evaluation Summary

  • Automated Charts - view sample
  • Compliance Summary
  • Recommendations
  • OFIs by Element

Internal Audit ChecklistISO 9001 Internal Audit Checklist v1

This is the 'Master Internal Audit Checklist' (see above) in MS Word format.

Contents

Master Internal Audit ChecklistInternal Audit Checklist

305 Audit Questions - view sample

MS Word

  • Context of the organization
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance Evaluation
  • Improvement
Written in International English
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