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Risk management and PFMEAs for operators

Programme overview

This ‘hands-on’ 1-day workshop is designed specifically for operators involved in the manufacture and fabrication of products. Using examples and case studies participants gain a practical, yet thorough, understanding of the effects of undesirable events on manufactured products and how they may be avoided in the first place.

Analysis of manufacturing and inspection methods

Creation of a Process Flow Diagram (PFD)

Practical risk-based thinking to determine potential failure modes

Determination of root causes and effective countermeasures

Development of a PFMEA from the ground up

Attendees are requested to provide the manufacturing and inspection documentation of a typical product so that the operation steps may be determined, the PFD created, and a full risk analysis undertaken culminating in a PFMEA.

Programme details

  • Understanding ‘risk’ in manufacturing operations –
  • definition of risk (undesirable ‘events’)
  • visualizing risk assessment
  • AS9100:2016 ‘risk-management’ process requirements
  • responsibilities of a risk management team

Team exerciseundesirable events we’ve experienced!

  • Reasons for risk identification and avoidance –
  • safety to operators & end-users
  • customer impact (quality & delivery)
  • cost to the company
  • risk management process stages
  • cost of quality – focus on prevention

Team exercisethe knock-on effects of undesirable events!

  • Reviewing manufacturing/inspection documentation –
  • characteristics of products/services
  • manufacturing process activities/steps
  • results to be achieved

Team exerciseidentifying and reviewing documentation

  • Identifying sources of risk in manufacturing –
  • Process Flow Diagram (PFD)
  • operation steps (internal & subcontracted)
  • understanding the terminology (item/requirement/failure mode)
  • identifying what could go wrong (potential failure modes)
  • product characteristics & sources of variation

Team exerciseidentifying the process flow and creating a PFD

  • Understanding and quantifying risk –
  • severity of the consequences (RAG)
  • likelihood of occurrence (RAG)

Team exercisequantifying our undesirable events!

  • Zeroing-in on cuses and their likelihood –
  • understanding the terminology (Cause/Likelihood)
  • overview of root cause diagnostic tools (5-WHYs, Fishbone, FTA & 8-D)
  • Determining the cause(s) of failure modes –
  • IAQG’s Fishbone diagram
  • IAQG’s ‘bones’

Team exerciseidentifying causes and quantifying their likelihood

  • Evaluating existing controls –
  • understanding the terminology (Controls/Detection)
  • identifying and classifying existing controls
  • detection – quantifying the effectiveness of existing controls

Team exerciseidentifying, classifying and ranking existing controls

  • Prioritizing improvements –
  • calculating the RPN = severity x likelihood x detection
  • prioritizing necessary actions
  • RPN and S + L + D

Team exerciseselecting an ‘appropriate’ action threshold

  • Devising new/improved methods & controls –
  • strategies to reduce risk
  • mitigate risk with ‘formal’ problem solving methodology
  • rescoring the S, O, D – and calculating the ‘new’ RPN

Team quizdevising/deploying ‘countermeasures’

  • Recording the risk management process –
  • the PFMEA ‘worksheet’
  • understanding the sequence of the PFMEA

Team exercisepopulating the PFMEA worksheet

  • Continual improvement –
  • monitoring deployment of ‘countermeasures’
  • re-evaluating severity x likelihood x detection when problems occur
  • developing 'generic' PFMEAs

Team assignmentidentifying and fixing ‘gaps’ in capability

Who should attend

Shop-floor operators and line inspectors involved in the manufacture and fabrication of products.

The course also provides as an excellent introduction to ‘risk-based thinking’ and PFMEAs for individuals planning to attend our 2-day AS13004 - Failure Mode & Effects Analysis & Control Plans course

Qualification

Individuals attending this course will receive a training certificate containing the TEC logo which is recognised internationally.

Competency will be demonstrated through the undertaking of all of the individual/team exercises and the populating of a PFMEA worksheet – based on an organization’s own product data.

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