Manufacturing Process Audit, Global Certified Auditors

Manufacturing Process Audit

Pro QC International is a global quality assurance company that offers manufacturing process audit solutions across five continents. We help qualify suppliers, validate production line processes, and investigate the root causes of defects.

In our experience, the quality performance of a good factory varies by production lines due to multiple factors such as people, equipment, materials, methods, production environment, and a plethora of other factors.

Pro QC’s Manufacturing Process Audit focuses on assessing the specific production line that is or will be producing your product. The assessment will assess the quality practice of a product from incoming material, through to every single stage of the production process, including material handling, in-process quality control activities, outgoing QA, and warehousing.

The outcome of the Manufacturing Process Audit is a thorough manufacturing audit report which includes a risk-based process control analysis of the factory. The report consists of Pro QC’s risk recommendations, on-site observations, performance scores, and high-resolution photos. The report will be used by supply chain and quality professionals to make better-informed decisions about the finer details of their supplier for factory performance.

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Sample Reports

Manufacturing process audits provide valuable insights that can lead to improved process optimization, superior product quality and minimized risk.

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When is a Manufacturing Process Audit Required?

Our clients often choose our Manufacturing Process Audit service for four reasons:

1. Supplier Qualification

Most companies have their own set of supplier onboarding processes and criteria to prequalify and manage their suppliers. In tandem with the internal approach, many clients use our Production Process Audit as part of the onboarding assessment. This assessment provides a deeper understanding of a specific production or assembly line of their product and another set of data points to consider before placing a purchase order.

Manufacturing Process Audit

This is especially useful for large orders of technical parts or assembly-intensive products where identifying and subsequently mitigating specific production risks is paramount.

2. Preproduction validation

Before entering mass production, conducting a thorough manufacturing process audit is paramount. By scrutinizing each step of the production process, manufacturers can identify potential flaws, streamline operations, and prevent costly deviations from standards. Production Process audits also play a pivotal role in upholding regulatory compliance, ensuring that products meet industry guidelines.

This meticulous process evaluation ensures that production processes align with defined standards, preventing defects, optimizing operations, and mitigating risks. By identifying these problems and risks before mass production, buyers can prevent defects from being produced in the hundreds of thousands, thereby reducing the cost of risk and poor quality.

3. Root Cause Investigation

Suppliers tend to perform well and produce according to specifications in the early days of the buyer-factory relationship. Over time, key personnel may change, operators come and go, tools and equipment wear out, processes drift and, as a result, the quality of the product deteriorates. This may manifest itself in any number of issues including delayed shipping, unanswered emails or complaints, receipt of defective products, and even field failures.

At the first sign of any field failure or receipt of a defective product, our client triggers an 8D and engages Pro QC to investigate the root cause of the quality defect. Pro QC will send our auditors on-site to analyze the problem through a thorough Manufacturing Process Audit. This risk-based analysis of factory process controls identifies the production bottlenecks, sources of defects, and activities that are poorly executed or lack standard quality control. We then report back to the client with the results and recommended actions, including dates for a Pro QC follow-up visit.

4. Continuous Improvement & Sustainable Performance

Efficiency gains are another noteworthy benefit. Buyers and manufacturers can implement improvements that enhance resource allocation and reduce production costs by pinpointing inefficiencies and bottlenecks through manufacturing process audits.

Moreover, a manufacturing process audit fosters continuous improvement. Insights gleaned from audits guide the adoption of best practices, innovative technologies, and optimized methodologies.

Incorporating audits within preproduction activities leads to an all-encompassing approach to quality control, bolstering product excellence and customer satisfaction. Ultimately, the manufacturing process audit serves as an invaluable tool for manufacturers to uphold standards, minimize risks, and elevate their production processes to new heights of success.

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Manufacturing Process Audit Assessment Criteria and Report

We understand that every product and component has its own specific production process and corresponding criteria, and we treat each client challenge as unique. That said, Pro QC has developed a unique manufacturing process audit framework and approach that can be applied across most industries, production, and product types.

Pro QC’s manufacturing auditors and experts will work with your team to tailor our manufacturing audit checklist to your specific production line and dive deep into your quality problems.

Our Manufacturing process audit checklist:

Technical Documentation
Incoming Quality Control (IQC) & Warehousing
Process Analysis (IPQC)

Process Input
Process Management
Personnel Resources
Material Resources
Process Efficiency
Process output & results

Maintenance and Inspections (OQC)
Packaging Shipping

Pro QC assigns process auditors and quality engineers with relevant experience in the industry, product category, and processes to perform the on-site Production Process Audit assessment.

The resulting report gives our client a snapshot of the risk profile of their production line and helps pinpoint areas with the highest room for improvements.

mpa report