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Documenting an QMS using the process approach

Programme overview

By the end of this 2-day practical course and workshop participants will have learned how to document a modern, process-based QMS to fully conform with any standard based on ISO 9001:2015 or AS9100:2016 (e.g. AQAP-2110 or AQAP-2310).

Students will receive a memory stick containing detailed templates of (i) a quality manual, (ii) operation process including ‘turtle diagrams’, flow-charts & procedures, and (ii) ancillary processes and resources. In fact, all of the necessary documentation on which to base their organization’s modern, process-based, quality management system!

Included in the course is an initial session to answer any questions regarding the requirements od any QMS standard.

Note: this course can also be presented on-site as a 2-day practical course and workshop.

Programme details

Planning the QMS

  • Identifying and understanding requirements for planning the QMS (Quality Management System)
  • Understanding the 'context' of the organization
  • Determining the ‘purpose’ of the organization –

  • identifying the organization’s purpose

  • Mission – Values – Vision

  • Specifying the organization’s 'strategic direction'

  • Capturing and addressing external and internal issues
  • S-W-O-T
  • PESTEL
  • Identifying interested parties and their requirements
  • customers, regulatory bodies, etc. -
  • additional QMS requirements
  • performance requirements (e.g. Q, D, etc.)
  • Upgrading and enhancing Quality Policy
  • Aligning, defining and documenting Quality Objectives
  • relevant functions, levels, and processes (including operation process KPIs)
  • defining a process for actively managing quality objectives
  • What – Who – When – How
  • deploying the P–D–C–A cycle
  • Handling the greater flexibility with QMS documentation
  • maintained and retained documented information
  • mandatory documented information
  • organization-determined documented information
  • Understanding the continuing need for a Quality Manual
  • minimum requirements
  • interested party requirements
  • expositions
  • quality plans
  • Confirming the role of the Management Representative
  • Deploying ‘risk-based thinking’
  • understanding the risk management process
  • identifying and quantifying risk
  • risk response planning
  • risk mitigation, monitoring and control
  • using practical methodologies for identifying and recording risk identification and mitigation

Documenting the QMS

  • Understanding the hierarchy of process-based QMS documentation
  • Defining the structure and contents of the Quality Manual
  • Documenting –
  • the purpose of the organization
  • external and internal issues
  • interested parties and their requirements
  • the scope of the QMS (including justified exclusions)
  • the responsibilities and authorities for organization roles
  • operations personnel
  • support personnel
  • top management
  • management representative
  • quality objectives
  • corporate KPIs
  • customer satisfaction KPIs
  • OPERATION process KPIs (e.g. PEARs)
  • Documenting a process-based QMS
  • introduction
  • principles and best-practices
  • Identifying the needs for QMS information –
  • maintained documented information
  • document control and personnel awareness
  • retained documented information
  • record retention times and disposition
  • organizational knowledge
  • Determining the organization’s (OPERATION) processes
  • describing their sequence and interactions
  • Ensuring ‘controlled conditions’ for (OPERATION) processes
  • using a Turtle Diagram to identify ‘controlled conditions’
  • What (with) – Who – How – Monitor
  • Detailed mapping of process activities
  • Inputs – Activity – Outputs – Department/Job Title
  • Determining, documenting and monitoring process effectiveness (KPIs)
  • Applying the above practices to the documentation of all operation processes (e.g. support and management processes)
  • Demonstrating conformity to all requirements –
  • QMS Process Matrix (AS9100:2016 conformance)
  • Compliance Matrix (customer and regulatory QMS conformity)
  • Documenting the control of nonconforming outputs process
  • Documenting the nonconformity and corrective action process
  • Documenting the operational planning and control process
  • NPI (new product introduction)
  • APQP (advanced product quality planning) & PPAP
  • transfer-of-work
  • Documenting the monitoring and measuring resources process
  • Documenting the customer satisfaction process
  • Documenting the internal audit process
  • Creating an agenda for management review

The above sessions will take up the majority of the time and will involve many workshops in which participants will create QMS documentation for their organizations Feedback will include Tutor advisement to point out misunderstandings and errors, and to suggest alternative approaches

Implementing the QMS

  • Developing a realistic transition timing plan for –
  • upgrading/re-structuring existing QMS documentation
  • implementing revised processes
  • Scheduling events to take into account organzational resource constraints
  • Identifying personnel ‘skills-gaps’, with special reference to –
  • Capability studies and SPC (AS9103)
  • Aerospace APQP & PPAP (AS9145)
  • Measurement systems analysis (AS13003)
  • Aerospace Problem Solving (AS13000)
  • Aerospace and Defence Risk Management & FMEA (J1739)
  • AS9100:2016 Internal Auditor Training (IRCA-certified)
  • AS9100:2016 Lead Auditor Training (IRCA-certified)
  • AATT courses and exams (IAQG-sanctioned)

Who should attend

Quality Managers, Quality Engineers and Consultants responsible for QMS documentation and maintenance.

The course is also relevant for managers and process owners who need to be involved with the design and documentation of their own departments, functions and processes.

Qualification

TEC's knowledge and experience of documenting hundreds of modern, process-based quality systems has been gained from working with clients in the UK, Europe, USA and Russia with these benefits -

  • drastic reduction in the volume of unnecessary narrative procedures - replacement with a truly process-based system with operation processes visually mapped onto just a few pages!
  • more effective and streamlined business models and user-friendly quality management systems - that are also easy to implement, audit and maintain
  • conformity (compliance) with multiple QMS standards and customer-specific QMS requirements

Our ‘know-how’ is available to your organization through this practical course and workshop. Participants will learn in a structured manner how to -

  • interpret multiple standards requirements regarding documentation
  • plan the upgrade of an existing QMS
  • create process-based documentation - using Microsoft© apps
  • document and implement systems for monitoring customer performance and process effectiveness
  • design their internal audit programme and management reviews
  • extend their quality systems to embrace environmental and other requirements in an IMS (Integrated Management System)

Assessment of learning is achieved through structured exercises undertaken individually and in teams. TEC’s Master Trainers provide feedback and advisement to ensure that best practice is fully understood in the context of the aerospace/defence industry.

Resources

Exploiting the AS9100:2016 changes

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