Making Sense of Corrective/Preventive Actions in ISO 9001, A Common Sense Guide for Hospitals Using NIAHO/ISO 9001

Making Sense of Corrective/Preventive Actions in ISO 9001, A Common Sense Guide for Hospitals Using NIAHO/ISO 9001

  Making Sense of Corrective/Preventive Actions in ISO 9001

A Common Sense Guide for Hospitals Using NIAHO/ISO 9001

Making Improvement Work

Wes Chapman

January 22, 2013

      clip art handyman

Continuous Improvement via the CAPA System

This is the second in a series of quick lessons in the 6 required documented procedures of ISO 9001 – 1) Document Control, 2) Record Control, 3) Internal Audit, 4) Control of Non-conforming Product, 5) Corrective Action, and 6) Preventive Action. These lessons are for hospitals’ adopting ISO 9001 – and this one is focused on making corrective and preventive action procedures required by ISO really deliver results.. These are designed to be 10 minute reads – introducing some concepts that I’ve found valuable.


Product defects in medicine are an awful concept – make your CAPA system work!

ISO is pretty straight forward about fixing problems – including both corrective and preventive actions – “…The organization shall take action to eliminate the causes of [potential] nonconformities [defects, failures and problems] in order to prevent their [occurrence] recurrence. Corrective actions [preventive actions] shall be appropriate to the effects of the [potential problems] nonconformities encountered. (Section 8.5.2 & .3 [preventive actions])”

Paraphrasing from the standard, this requires: 1) Review of actual and potential problems, 2) determining the root cause of the problem(s), 3) Evaluating the need for action, 4) Determining and implementing the action required, 5) Recording the results of the actions taken, and 6) Reviewing the effectiveness of the actions. In layman’s terms – identify the problem, determine the root cause, plan the fix, fix it, and prove that it was actually fixed with real world data.

If this sounds like an invitation to apply your favorite Lean/Six Sigma (LSS) tools – you are absolutely correct. The maddening thing about ISO, is that it sets up the framework to use all of your favorite quality tools, but never once mentions them be name – or even suggests their use. For many old hands at process improvement – but new to ISO – this omission seems a heresy. How could ISO never once even imply the use of the process improvement tools that have revolutionized the concepts of process improvement (PI) and quality?

The answer – ISO is not prescriptive. But it does offer the best quality management system (QMS) ever invented to make LSS tools effective in complex systems like modern hospitals (check out my white paper on Complex Medical Quality Systems ).

Three Practical Considerations – Making a CAPA System Work

First, One System Only!

This is the single most important consideration for senior management – only have one process improvement system – and for ISO 9001 compliant facilities this must be the CAPA system. This is the hardest thing to achieve – and the most important. No clinical care delivery system can support multiple uncoordinated performance improvement efforts. Invariably, they end up contradicting each other and the process changes almost never filter back into the documented P&P system, which is legally required to control all operations.

Most facilities that I visit have a minimum of four disparate PI systems functioning in “parallel universes”: 1) Some form of committee based P&P system – controlled through accreditation standards (TJC or DNV), 2) Some form of PI process improvement effort focused on Lean & Six sigma tools (including TPS, PDSA, A3 etc.), 3) Some top-down clinical improvement effort (often involving 3rd party consultants) focused on Infection Control, Serious Reportable Events (SREs) etc., and 4) A variety of department level initiatives, idiosyncratic in goals, staffing and methods.

A good CAPA system easily accommodates all of these PI efforts, and rolls them into a single conformable system. The CAPA system allows senior management to:

  • Understand and control all improvement efforts in a single system,
  • Conform all PI efforts to a single execution methodology,
  • Utilize any PI tools or third party consultants,
  • Understand the problem being addressed, define the steps to fix/prevent it, prove that the solution has been effective, and monitor ongoing effectiveness.

Second – Tier the CAPA system to reflect Risk and Impact (Cost & Care)

Not all problems are created equal – that’s why we evaluate risk and potential cost and care impact. The appropriate response to a Sentinel Event is very different than the need for a small 5S project in an outpatient clinic.

I normally recommend a 3 tier CAPA system:

  1. SRE CAPAs – these are any corrective/preventive action that you don’t want your Chairman reading about in the newspaper – without hearing from you first. These should be less than 1% of the total CAPAs, but will take about a third of the time for resolution. SRE CAPAs are normally related to complex problems, and require a cascade of failure to come to full fruition.
  2. Normal CAPAs – done to address actual or potential problems and non-conformities, and resolved via the normal, complete CAPA process. Normal CAPAs should be 20-30% of the total CAPA load, but account for 40-50% of total project time, and
  3. Penalty Box tickets – a “CAPA light” which is really a counting or operational audit function to determine the scale of recurring problems and/or the completion of selective repetitive procedures. These are called penalty box tickets, because like in hockey, they are designed to be resolved in 2 minutes or less. PB Tickets should be the vast majority of total projects, but should not take more than one third of total work time in resolution.


% of total   CAPAs

% of total   Work Time

Type of   Failure Addressed


SRE   CAPAs ≤   1% 30% Complex   failure involving cascading events. High risk, cost and exposure. This   needs to be the area of senior management focus. Pro-active preventive   action. Bow-tie risk analysis
Normal   CAPAs 20-30% 40-50% Linear   process failure or simple system upgrade. Most   LSS projects fit into this category. Most departmental projects fit here.
Penalty   Box Tickets 70-80% 20-30% Recurring   small problems Simple   and very valuable tool.


Third – You have the tools – use them!

Get some help from your PMI trained folks. I always run my own CAPA systems like a single project management system. I like a simple user interface for active projects, with a simple dashboard for projects underway and key operational metrics on the same platform. Running operational metrics with projects allows the easy detection of post project impact on expected outcomes. If the outcomes don’t materialize – the sooner it is exposed the better. Keeping metrics running in the background for completed projects is a very good idea – provided that the data is sourced automatically. Fixing things is easy – keeping them fixed is a whole different problem.

 Project Mgt Tools

Simple Project Mgt. Tools Drive the CAPA System

Most hospitals staffs are hardened to the “new-new-thing” phenomena in process improvement and quality. My experience is that most busy clinical staff personnel are looking to reduce the aggregate burden of quality compliance – and walking in the door with yet another new quality system/tool is not welcome. When I put in a new CAPA system, I’ve had the best luck calling it (and operating it) as a project management system. The CAPA system is simply the way projects will be initiated, run and evaluated.

Let your LSS system live inside the CAPA system – and make sure that people use it! I have seen way too many situations where, “XYZ department won’t use LSS tools.” There are a number of terrific LSS cloud based integrated project packages available today. These offer a number of major advantages:

  • They force compliance with a standardized PM system
  • They provide a consistent framework for CAPA analysis and resolution
  • They provide access across multisite organizations
  • They allow real time project update and analysis
  • They are Fair and Transparent.

The CAPA system is the heart of value delivery in ISO. If your CAPA system doesn’t work, things don’t get better – so what is the point. I’ve run good CAPA systems, and suffered through bad ones. Let me know if I can help.

Wes Chapman
Written by Wes Chapman

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