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Effective corrective action for managers & process owners

Programme overview

By the end of this 1-day course & workshop management and process owners will be able to resolve NCRs (Nonconformity Reports) and CARs (Corrective Action Requests) in a timely and effective manner and understand how to monitor and ‘actively manage’ both QMS performance and process-level effectiveness (PEARs).

Sources of NCRs and CARs come from CB audits, customer audits & complaints and, of course, internal audits

The course specifically addresses ISO-9001-based standards (clause 10.2 Nonconformity and corrective action) and is applicable to AS9100 series, AS13100, IATF 16949, AQAP 2110 and AQAP 2310. For aerospace, the root cause codes now being requested by the IAQG are incorporated.

An integral part of this course is instruction in a battery of problem solving methods including ‘Fishbone’ and ‘5-WHYs’ in tandem!

A major feature are the Workshop Sessions in which attendees present their own NCRs for analysis and resolution.

Programme details

Introduction & Welcome

  • Explanation of the highly interactive nature of the course, stressing that the majority of the time will be spent undertaking practical activities and workshops
  • Introductions of the tutor(s) and participants
  • Agreement of course rules and timekeeping

Purpose and value of audits

  • Understand that audits uncover deficiencies in QMS processes (nonconformities)
  • Learn that audits evaluate evidence and generate findings, and there are three types of audit
  • Appreciate that audit findings provide top management with information on the performance and effectiveness of the QMS

Nonconformities and corrective actions explained

  • Understand nonconformities and applicable QMS requirements
  • Learn about sources of nonconformities, their criteria and types
  • Appreciate the difference between correction, corrective action and preventive action
  • Understand ISO 9001-based standards common requirements for corrective action

Standards, clauses and audit questions

  • Appreciate how auditors create their questions
  • Understand the structure of QMS standards
  • See how auditors create audit questions

Audit activities, sequence and NCRs

  • Understand the sequence of audit events
  • Learn about –
  • Nonconformity report (NCR) template
  • Organization’s planned activities template
  • The 1-page nonconformity report (NCR) form

Classification of NCRs

  • Understand how CB auditors classify NCRs as either major and minor
  • Appreciate the difference between ISO 9001 and AS9100 classifications
  • Learn how to respond to a request for containment, soft grading and repeat nonconformities

1. Nonconformities based on audit findings

  • Appreciate how auditors record the details of a nonconformity on an NCR
  • Learn now to react to an NCR, determine the root cause(s) and take necessary corrective action
  • Understand how to summarise and record the organization’s planned activities

2. Nonconformities based on customer performance and satisfaction

  • Understand AS9100 requirements for customer satisfaction
  • Learn how to deploy corrective action(s)

3. Nonconformities based on current manufacturing issues and operation process effectiveness

  • Understand process effectiveness requires conformity and performance
  • Become proficient in handling and scoring ‘PEARs’
  • Learn how to deploy corrective action(s)

4. Nonconformities based on new product development

  • Understand the principles and practices of new product development – and the ‘quality focused’ approach imposed by APQP & PPAP
  • Learn how to deploy corrective action(s)

5. Nonconformities based on supplier issues

  • Understand that your organization is responsible for the conformity of all externally provided processes, products, and services
  • Learn how to monitor supplier performance
  • Appreciate the need to ‘flow down’ corrective actions to suppliers
  • Learn how to deploy corrective action(s)

Summary of root cause determination models

  • Learn about different models and methodologies for determining root causes
  • Appreciate the IAQG root causes classification
  • Learn how to deploy corrective action(s) and never accept ‘human error’ as a root cause!

Corrective action responsibilities for QMS audit nonconformities

  • Learn about audit activities, participants and their responsibilities
  • Appreciate how the CBs manage nonconformities for the certification program
  • Understand the documentation of the nonconformity report (NCR) – and who is responsible for what

Reviewing/rejecting an auditor’s NCR

  • Understand that auditees are required to acknowledge, respond and react to NCRs
  • Learn that they can, of course, reject them – provided this can be justified!
  • Example: audit of inspection gauge calibration
  • Auditee’s appeal for NCR withdrawal – justified?
  • Auditee’s appeal upheld – NCR withdrawn

Workshop sessions

  • Multiple workshops focused on actual NCRs presented to your organization
  1. acknowledge, respond and react to the nonconformity
  2. take action to control and correct it and deal with the consequences – i.e. containment
  3. review and analyse the nonconformity – i.e. accept/reject with reasons
  4. determine if similar nonconformities exist, or could potentially occur
  5. devise and select effective systemic corrective action(s)
  6. deploy the selected action(s)
  7. verify the effectiveness of action(s)
  8. update risks/opportunities, if necessary and give consideration of the impact on similar processes and products
  9. make changes to the quality management system, if necessary

Document your organization’s planned activities

  • Containment Action(s):
  • Correction(s):
  • Root Cause(s):
  • Corrective Action(s):
  • Communication to the auditor
  • Closure of the NCR
  • Read-across – if applicable

Who should attend

All members of the organization's leadership team -

  • Top Management
  • Process/Department Managers (at all levels)
  • Process Owners (manufacturing and assembly)
  • Purchasing/Procurement managers

Qualification

This highly interactive course and workshop provides all the guidance needed to ensure that members of the leadership team can handle responses to NCRs & CARs in an effective and value-adding manner.

The syllabus includes a battery of quality tools and details a tried-and-tested methodology for resolving NCRs & CARs. Everything is taught through quizzes, examples, scenarios and team exercises.

The IAQG’s 'root cause codes', now being used by the CB Auditors, are included.

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