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Sep 23, 2014

Why Do Corrective Actions Fail?

Why Do Corrective Actions Fail?
There are two fundamental reasons why 
most corrective actions  programs fail.
by Ed Grounds, President
Integrated Solution Providers Software, Inc.

Each year, the most popular learning course we provide is targeted at developing the skills necessary for our customers’ associates to implement their corrective action programs effectively and efficiently. Throughout the years, we have been asked the same question hundreds of times, “What are the most common reasons corrective actions fail?”  Usually this question is asked during the corrective action learning session by a management team member hoping that we will deliver the message to the other team members that they are failing.   Normally, we turn the question back around to the group and ask them why they think their corrective action program fails.  The most common answers we hear are:  limited time, resources, training, or not knowing which tools to use.

The Easy Answer

The easy answer is to agree that all of these can be the issue, but that would not be helping our customers understand that there are two fundamental reasons as to why most corrective actions programs do not obtain the output they expect.

First, we try to help them understand that time, resources, training, etc., are the symptoms of a larger concern, which is that the team has not been empowered with the authority necessary to solve the problem permanently. In this context, the term “authority” means that the  organization must provide the team an open and free environment in which to operate, including the ability to obtain the resources, time, training, expertise, and information (including financial data)  necessary to permanently resolve the issue they have been assigned and to deliver the best solution possible.



This article is related to the Whitepaper: Clinical CAPA: Embedding Quality into Clinical Research To get the full details, please download your free copy
We must understand that a corrective action team will derive an answer to the problem within the scope of the authority granted to them. (This includes the freedom to actually present a solution that management may not want to hear.) The team’s responsibility should be to present the best solution and let management decide whether or not to approve it rather than providing an answer they think management will find acceptable.  Too many times, teams will provide a solution to solve a problem based on what they think will be found acceptable by management. In these cases teams will start with an answer to solve the problem first based on what they think is an acceptable response for management and then work the corrective action process backwards.

What we strive to impart in our workshops is that management must first decide if they are truly committed to the corrective action process and willing to provide the necessary authority to the team in order to resolve the issue permanently.  In many cases, this means they must grant the “Champion” special authority over and above the authority they have in order to obtain the desired results.

Often times, we see Champions assigned based on his or her position, availability, perceived responsibility, or department.  In these cases, little consideration is being given for what it actually takes to tackle and permanently resolve a problem.  When this happens, the team works within the scope of the authority they believe they have and the solution fits within this narrow scope.

Problem Definition Challenge

The second major contributing factor to failed corrective actions is the problem definition itself. The team has been instantly set up for failure if the problem statement (which becomes the team charter) is not sufficiently defined, understood, and narrowed to a solvable problem.  We have read many problem statements that may have well asked the team to cure world hunger. In some cases, more than one corrective action may need to be initiated to provide each team with a solvable problem. When a problem statement is too broad, it inevitably leads to allowing team members to introduce “fixes” for issues that are personal agenda items and are not a direct contributing factor to the specific failure within the system related to the concern that must be addressed. Many times, broad problem statements are generated because of vague information received from the customer, from internal sources based on high level data, or from a perceived problem which was not a real issue that should have been assigned to the corrective action team in the first place.  (Understanding opportunities for failure in relation to a measure of failure is essential in determining if a problem truly exists.) The problem statement of a corrective action should focus the team efforts to a specific failure of the system within a defined time frame and limited to only the inputs related to the failure (customer, machine, operation, shift, part number, etc.). Once a permanent solution is derived and approved, then and only then, should the team look for opportunities to leverage the solution if appropriate outside the scope of the defined problem statement. Keeping this focus takes discipline on the part of all team members and needs to be managed by the team leader.

Defining Your Goals

We highly recommend to our customers that they define within their systems what the criteria is for issuing corrective actions for concerns that they expect to be resolved permanently, and that they set criteria for those issues that they would only expect incremental gains on. By doing so, when a corrective action is assigned and the expectation is that the problem solving efforts eliminate the issue permanently, the management team will understand that they must provide the authority necessary to achieve these results.

When organizations come to terms with what it really takes to implement and maintain a robust corrective action process, they realize that the success of the teams all along has rested with the management team members themselves and their own ability to create an environment necessary for their teams to be successful.

Do you serve on a corrective action team?  What process did you use to define your goals? For more information about working with CAPA, download the white paper "Does Your CAPA need a CAPA?" from MasterControl.


This article is reprinted with permission of Certified Enterprise Risk Manager® (CERM) Academy.

Ed Grounds is a Six Sigma Master Black Belt who founded ISP Software, Inc. in 1997.  ISP Software, Inc. offers quality information system software products, training, and consulting services primarily targeting manufacturing organizations which are designed to improve their efficiency and profitability.  His diverse background and over 30 years of experience with quality operating systems uniquely qualified him for the development of the quality information system products offered by his company. Mr. Grounds has been retained to provide the function of Quality Director and General Manager for Fortune 500 companies both domestically and internationally. Mr. Grounds continues to provide learning workshops focusing on Six Sigma, Lean Manufacturing, Corrective and Preventative Actions, and Advanced Product Quality Planning strategies each year to assist ISP Software’s customer base in achieving their goals. Contact Ed:

Integrated Solution Providers Software, Inc.
P.O. Box 1281
Mount Pleasant, MI 48804
Toll Free:   877.865.7562
Fax:            989.317.0676
E-mail:       Ed@ispsoftware-solutions.com





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