Manufacturing Process Audit

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 score and high-resolution photos. The report will be used by supply chain and quality professionals make better informed decisions about the finer details of their supplier for factory performance.

When is a Manufacturing Process Audit Required?

Our clients choose a Manufacturing Process Audit for two reasons:

1. Supplier Prequalification

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 Manufacturing 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.

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. Root Cause Investigation & Sustainable Performance

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 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 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 of 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.

Manufacturing Process Audit Assessment Criteria

We understand that every product and component has their own specific production process and corresponding criteria, and we treat each client challenge as unique. That said, we developed a list of commonly required procedures, documents and process controls that can be assessed during a Manufacturing Process Audit. The resulting list below is usually the focus of our assessment, however it can be tailored to specific client requirements:

  1. Technical Documentation
  2. Production Planning
  3. Production Control Plan
  4. Purchasing Planning & Control
  5. Employee Training & Qualifications
  6. Incoming Material Control and Testing
  7. Manufacturing Process Control
  8. In-Process Quality Control
  9. Outgoing Quality Control & Warehousing
  10. Management Support

Pro QC assigns auditors and engineers with relevant experience in the industry, product category and processes to perform the on-site Manufacturing Process Audit assessment. Our in-house consultants can then tailor the audit to meet the buyer’s requirements and challenges.

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