Quality Management & Training

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CAPA - CORRECTIVE AND PREVENTIVE ACTION

CAPA - CORRECTIVE AND PREVENTIVE ACTION



Corrective and Preventative Action (CAPA) - Mistakes occur, we all understand that, but not reacting to them is as far as our customers are concerned, unforgiveable. Reacting not just to the immediate problem and its consequences, but also addressing longer term corrective and preventive actions - ensuring the problem never happens again.

CAPA (Corrective and Preventive Action) is about addressing issues, problems, incidents or accidents in a structured, methodical manner using widely accepted approaches and techniques which provide evidence and confidence to the customer that the organisation concerned as acted with due diligence, which includes documented evidence, supporting the conclusions and consequential actions taken.

Global regulatory agencies in the healthcare industries such as FDA, EU regulators and MHRA and the financial FSA or FCA (Financial Conduct Authority) are all targeting Corrective and Preventive Action (CAPA) systems during their routine inspections, to determine an organisation's ability to supply products and services that are consistently fit for purpose.  Common issues raised by these regulatory agencies include:

  • Corrective and Preventive Action effectiveness was often hampered by poor Management information.
  • Lack of evidence using Corrective and Preventive Action regarding remedial action.
  • Management information collected did not drill down and consequently hampered effective Corrective and Preventive Action.

 


BUSINESS BENEFITS


To enable delegates to:

  • Understand and implement the “CAPA methodology"
  • Understand and practically employ the basic techniques associated with CAPA
  • Identify where CAPA can be used for best effect
  • Coordinate and motivate the CAPA team to provide real, tangible solutions to what appears to be intractable quality problems.
  • Train others in the CAPA methodology
  • Provide the opportunity to make real major financial saving through QM&T's pre and post course supported assignment scheme.
  • Be QM&T validated and certificated practitioner.

Reason for CAPA:

  • A part of policy and goals of the organisation
  • Providing long term improvement
  • A powerful vehicle for training people
  • Analysing for root cause is a mind-set, it takes more time at first but is a ‘high return investment’ for eliminating fire fighting
  • A regulatory requirement. For example healthcare providers, are obliged to comply with Private and Voluntary Healthcare Regulations. Specifically Regulation 28 requires the notification of any serious events (this can range from death of a patient to allegation of misconduct). Regulation 28 will necessitate the completion of a Root Cause Analysis investigation. 

 


WHO SHOULD ATTEND?

  • Quality managers, Quality Engineers, Software, Food & Drug, etc. professionals who wish to apply the CAPA model and methodology to problem solving together with obtaining a clear knowledge of CAPA associated techniques and its application to continuous quality improvement.
  • Organisations wishing to move away from fire fighting to problem elimination approach.
  • Organisations wishing to comply with the requirements of Clinical Negligence Schemes (CNST) and Risk Pool Schemes (RPST).

 


COURSE STRUCTURE

The CAPA course is broken down into the natural CAPA four-phase processes:

  •  Phase I: Problem identification
  •  Phase II: Problem description
  •  Phase III: Cause analysis
  •  Phase IV: Solution development

Together with presenting practice examples of CAPA techniques and case studies

Morning

  1. Phase I: Problem identification: Understanding the strategies for fact gathering will include looking at customer complaints, interrogating the accounts including credit records, interviews, workshops etc. The objective is to gather as much information as possible on problems or quality deficiencies. Selection is carried out in the next phase.
  2. Phase II: Problem description: The criteria for including problems in the analysis needs to be fully understood. These will include the use of flowcharts, critical incident, spider charts, purpose and application matrices and problem understanding checklists.
  3. Phase III: Cause analysis: Cause analysis tools that may be used are histograms, Pareto charts, scatter charts, relations diagrams and affinity diagrams. Some but not all of these would be used according to their suitability in particular circumstances. Following this the cause and effect stage has been reached and the effects and therefore potential root causes can be identified.  Tools for this are cause and effect charts, matrix diagrams and the “five whys” or the “why, why” chart.
  4. Phase IV: Solution development: Potential solutions need to be developed and presented for the decision makers and the comparative benefits and cost effectiveness of all prevention options shown.

Afternoon

  1. Practical case studies associated with CAPA.
  2. Exercises associated with re-enforcing the morning's CAPA theory.

 

Course Options:

 

1. Pre-course visit to develop and adapt the course and associated material to suit the client's needs.

2. Pre and post course delegate assignment with QM&T support. The delegate’s assignment / project would be fully assisted and supported online and assessed by one of our qualified and experienced staff. This work based assignment approach has regularly provided significant financial savings, reinforce lessons learnt and provided a practical demonstration of delegate competence.  This (on successful assignment completion) provides the delegates with a QM&T Practitioner certificate.  This approach is often useful where delegates may not (due to other pressures) be able to immediately apply the newly acquired knowledge.

3. Delegate assignment presentation provides the delegate with the opportunity to demonstrate their achievements to a selected group such as; CEO and Directors, key Managers and Supervisors, etc.  This gives the delegate the opportunity to credit and recognise their performance and motive others to emulate.

 


COURSE DATES AND COST