Thursday, September 16, 2021

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PMC offers to develop, implement, conduct, and sustain the internal and 2nd Party auditing programs. In addition, PMC provides internal and lead auditor training and certification for:

Internal Auditing. Quality Management System standards require that organization have internal audit program that:

  • Covers the entire quality management system including quality management system audits, manufacturing process audits, and product audits.

    • Quality Management System Auditing, using process-approach is to verify compliance with QMS standard. Organizations should also sample customer-specific quality management system requirements for effective implementation.

    • Manufacturing Process Auditing, using customer-specific approach is to determine the process effectiveness and efficiencies. Organizations should determine the approach if not defined by customer. Organizations need to make sure they include all shifts along with handovers from shift to shift, if multiple shifts exist. PFMEA, Control Plan, and associated documents should be used for the audit.

    • Layered Process Auditing is a system of audits performed by multiple levels of supervision and management to monitor key process, product, and service characteristics to verify process conformance on an ongoing basis. PMC will establish, develop, and implement an effective LPA program to provide a reduction in variation along the manufacturing line as well as non-manufacturing functions.

    • Product Auditing using customer-specific approach is to verify product’s conformity to specified requirements. Organizations should determine the approach if not defined by customer.

  • Be prioritized based on risk, internal and external performance trends, and criticality of the processes.

  • Needs to include Software development program if the organization is responsible for software development.

  • Assures the frequency of audits be reviewed and adjusted, if necessary, based on occurrence of process changes, internal and external nonconformities, and/or customer complaints.

  • Guarantees the effectiveness of the audit program shall be reviewed as a part of management program review.

2nd Party Auditing. Organizations should include a second-party audit in their supplier management approach. Some secondary-audit examples are:

  • Supplier Risk Assessment
  • Supplier Monitoring
  • Supplier QMS Development
  • Process Auditing
  • Product Auditing

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Customer Feedback

“Your engineering team provided a well organized effort in capturing difficult parameters within a hospital environment.  By constructing a graphic model, we were able to visualize patient traffic, and determine several operational conditions.” 
Global EPCM firm Business Leader, Health Care Studio

“This is just a quick letter to let you know how personally pleased I am with the results of our recent project.  [PMC engineer] provided us with a first rate model that was an important part of [our company] receiving a large Purchase Order from [a major automotive OEM] to build the project that had been modeled.”
World-wide supplier of Assembly and Test Equipment, Proposal Manager

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