Michael Hammer says, “Business has embraced process management as a way of life,” and this philosophy has been fully embraced by the engineering and manufacturing industries. Manufacturing process audits ensure that the organization makes effective process management not only part of the business but a way to do business, adding to reliable and high-quality manufacturing practices every day.
A manufacturing process audit is a systematic and in-depth examination of manufacturing processes to assess production performance and identify potential or actual manufacturing issues. It is used for many reasons, such as:
- To assess whether all processes are functioning correctly for manufacturing the product.
- To proactively identify production risks before they escalate through the production process.
- To trace the root causes of production problems.
- To institute a culture of continuous performance evaluation so that manufacturing programs are run in the most effective way possible.
Read our post What is a manufacturing process audit to learn how they are utilized in product manufacturing and sourcing programs. We will explain how they can be adopted and provide a practical checklist for seamless integration into your production journey.
What are the Key Aspects of a Manufacturing Process Audit?
To understand what is a manufacturing process audit, let's have a look at its key components.
1. Process Documentation and Compliance
Each manufacturing process audit starts with a thorough consideration of the product or part that is being made. Due regard is given to the manufacturing inputs and processes that are required to make the part.
Having a strong technical understanding is essential to a successful audit. The auditor then carefully analyzes each step of the production process to see that each stage is performed correctly and to identify production problems or risks.
The auditor may also examine whether the manufacturing activities are being performed in accordance with industry standards and internal regulations.
2. Material, Tooling, and Equipment Inspection
The foundation of each production process is its materials, tooling, and equipment. Auditors examine the quality of raw materials to assess how well they adhere to specifications. The calibration and condition of the machinery are extensively inspected to ensure peak performance.
Process auditors may be called on to validate tooling and verify that they are properly adapted for making the product or part. This is essential as if the tooling isn’t correct, this can create many production issues later on.
3. Quality Control Measures
In the manufacturing industry, quality control is essential. Audits examine in-process quality controls, sample procedures, testing techniques, and output consistency in order to assess the effectiveness of current quality control measures.
4. Regulatory Adherence
Manufacturers work in a world of restrictions and regulations. The audit makes sure that the manufacturing procedures adhere to national and international laws, protecting against penalties and guaranteeing consumer safety.
What are the Types of Manufacturing Process Audits?
The following three manufacturing process audits are common.
1. Paper-based Checklist Audits
Paper-based Checklist Audits involve breaking down the audit process into a checklist to make sure that each step is carried out without deviation.
Limitations It relies on human memory, which is vulnerable to error, and does not provide an explanation for errors.
2. Card-based Audits
In Card-based audits, organizations develop an audit card that the process operator fills out to speed up audits and reduce the workload on supervisors. It is more efficient than paper-based checklists because it doesn't rely on memory and can help to identify gaps and deviations.
Limitations Only identifies issues that occurred during the particular session and does not provide a comprehensive picture of the production process.
3. Layered Process Audits
Layered process audit involves performing a variety of audits, including process mapping audits, card-based audits, and paper-based checklist audits, for each shift. This approach ensures thorough coverage of the manufacturing process, detects issues before they become defects, and enables prompt rectification. It helps to identify and correct problems early before they cause defects in the finished product.
To maintain a seamless and effective manufacturing operation and to maximize the audit process efficacy, it is essential to select the appropriate type of audit, maybe using a combination of techniques.
How to Conduct the Manufacturing Process Audit?
The manufacturing process audit normally follows three steps:
1. Entrance Meeting
An entrance meeting marks the start of the audit process. The audit scope, objectives, and anticipated results are discussed in this meeting with important stakeholders. This meeting paves the way for open communication in the audit process.
2. Examination and Evaluation
A thorough investigation of the manufacturing process is done by auditors. This covers on-site inspections, employee interviews, and a comprehensive assessment of process inputs and outputs. Each aspect is carefully evaluated in comparison to predetermined standards.
3. Reporting and Recommendations
Auditors organize their findings into a thorough report after the examination. The areas of compliance, areas for improvement, and, if necessary, remedial actions are highlighted in this report. Manufacturers are given the opportunity to improve their processes through clear and practical recommendations.
When is a Manufacturing Process Audit Required?
Companies usually select a manufacturing process audit service for the following four reasons:
1. Supplier Qualification
For prequalifying and managing their suppliers, most businesses have their own set of supplier onboarding procedures and standards. Many clients use a Production Process Audit as part of their supplier selection and onboarding strategy. This evaluation offers a deeper understanding of their supplier’s production capabilities as well as additional information about the supplier’s operations to take into account prior to making an order.
2. Pre-production validation
It is important to carry out a complete manufacturing process audit before starting mass production and if you are at the New Product Introduction stage. Manufacturers can identify potential defects, speed up processes, and avoid costly deviations from standards by carefully reviewing every stage of the production process. Production Process audits are essential for maintaining regulatory compliance and guaranteeing that goods comply with standards set by the industry.
Buyers can lower the cost of risk and poor quality by recognizing these issues and risks before mass manufacturing, preventing faults from being generated in the hundreds of thousands.
3. Root Cause Investigation
Initial product quality and on-time delivery are often satisfactory in the buyer-supplier relationship; however, problems might develop over time as a result of factors like employee turnover and equipment wear. Clients can take a proactive stance to resolve probable flaws by initiating an 8D process and hiring third party auditors for root cause investigation.
4. Continuous Improvement & Sustainable Performance
By exposing inefficiencies and challenges, manufacturing process audits enable both buyers and producers to improve resource allocation and lower production costs. By offering insights that direct the adoption of best practices, cutting-edge technologies, and improved procedures, these audits also promote continual improvement. Audits contribute to a thorough approach to quality control when they are incorporated into pre-production processes, ultimately enhancing product excellence and customer satisfaction. Overall, manufacturing process audits are incredibly useful tools for businesses to maintain standards, reduce risks, and improve production processes. You can use AMREP Manufacturing Audit Services to minimize manufacturing problems and identify suppliers' technical weaknesses.
What is a Manufacturing Process Audit Checklist?
A manufacturing process audit checklist is a structured tool used to systematically analyze and assess the processes and practices inside a manufacturing process. A sound checklist highlights the criteria that should be considered in a specific area. It often includes a list of specifications, guidelines, or standards that auditors must adhere to verify compliance and identify any inconsistencies or areas of improvement in the production procedures. During the audit process, the checklist contributes to maintaining consistency, quality, and conformity to industry standards, enhancing the general efficiency and effectiveness of manufacturing operations.
Manufacturing plant managers and compliance officers generally use this kind of checklist to make sure that the operation is adhering to all relevant legal and organizational requirements.
Here is a sample Manufacturing Process Audit Checklist. Remember that the exact criteria will vary depending on the industry, the nature of the product, the manufacturing processes utilised, and the applicable quality standards. A general example of the concept is presented here:
1. Process Documentation
✓ Are standard operating procedures SOPs considerably available and documented?
✓ Are employees adhering to predefined protocols?
2. Equipment and Tools
✓ Are all of the tools and equipment in good operating order?
✓ Are equipment calibration and maintenance performed on time?
3. Materials Handling
✓ Does a suitable system exist for the handling and storage of raw materials?
✓ Are materials properly labeled?
4. Quality Control
✓ Are quality control checks executed at key stages?
✓ Is there a process for separating faulty goods?
5. Safety Measures
✓ Do all employees adhere to safety rules?
✓ Are you using personal protective equipment (PPE) correctly?
6. Training and Competence
✓ Have operators got the right training for their positions?
✓ Do employees understand emergency procedures?
7. Environmental Controls
✓ Are there policies in place to manage aspects of the environment that might affect the process?
- ✓ Is the infrastructure maintained in a way that guards against product damage or contamination?
8. Production Flow
✓ Is the production flow planned to be as effective and waste-free as possible?
✓ Do policies exist to deal with production process inefficiencies and delays?
9. Documentation Accuracy
✓ Is the documentation, including production logs and quality control reports, correct and current?
✓ Any modifications to policies or practices have been adequately documented and communicated?
10. Waste Management
✓ Does the production process generate waste that needs to be managed and disposed of?
✓ Are trash disposal methods in accordance with environmental laws?
11. Supplier Management
✓ Is there a process in place for assessing and keeping track of the quality and dependability of suppliers?
✓ Are arriving materials checked for quality and spec compliance?
✓ Do the various departments engaged in the production process communicate well with one another?
✓ Are there established procedures for dealing with and quickly resolving communication problems?
13. Performance Metrics
✓ Are key performance indicators (KPIs) for the manufacturing process defined and tracked?
✓ Is there a process for ongoing development based on performance metrics?
✓ Does a technique exist for tracing items back to their raw materials?
✓ Can items be tracked throughout the whole production process for quality control purposes?
15. Regulatory Compliance
✓ Is the production procedure in accordance with current industry standards and regulations?
✓ Are there plans in place to adjust to any potential process-affecting changes in regulations?
This Manufacturing Process Audit checklist covers a number of key manufacturing areas, namely: standards compliance, quality control, safety, and continuous improvement. Again, we reiterate that this can vary from company to company and can involve deep technical evaluations.
To sum up What is a manufacturing process audit? It provides the foundation for quality assurance, good manufacturing practices, and operational excellence. Manufacturing process audits are the compass that directs businesses to excellence in every product they produce.
If you are facing manufacturing problems or want to get better performance from your suppliers, simply contact our team of expert auditors at AMREP Supplier Management Services.