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Corrective and preventive action

How can a company successfully navigate through, and defend itself, in product safety concerns?

Recently, General Motors (GM) has recalled 1.6 million vehicles because of a faulty ignition switch. GM said a heavy key ring or a “jarring event,” such as running off the road, could cause the ignition to slip out of position, shutting off the power and causing the air bags to fail in a crash. GM has linked 13 deaths to the defective switch. Meanwhile, an auto safety group found more than 300 possible fatalities—far more than the 13 fatalities GM has acknowledged so far in cars with un-deployed airbags.

It is alleged that the automaker had known since it first started selling the Saturn Ion in 2002 that the ignition switch was too weak to hold the key and was located far enough down that the driver’s knee could inadvertently jostle the key, cutting off the engine. Despite internal concern about the defect, GM put the same ignition switch in many of its models during years 2005 to 2007.

The cause mentioned for the unintended ignition switches shut-off is that the “switch detent plunger” did not supply enough torque to retain the switch in position. General Motors was aware of this potential problem, and held meetings about it, as early as 2005. On June 5, 2014, an investigating attorney reported that the company’s failure to fix the defective switches sooner was not due to a cover-up on the company’s part, but rather due to “their failure to understand, quite simply, how the car was built.” Regardless, a large number of lawsuits have been filed in response to the recall, by those claiming to have been injured due to the recalled vehicles’ faulty switches, and GM will need to payout billions of dollars in damages to settle these lawsuits.

These recalls, and many others in every industry, are examples of delayed and/or inadequate reporting to the regulatory agencies, and failure to implement corrective actions to known safety concerns. A sound quality management system that incorporates Corrective And Preventive Action (CAPA) procedure is necessary to avoid serious problems.

Definitions

Do not confuse corrective action and preventive action. In ISO 9000 standards, corrective action is defined as “action to eliminate the cause of a detected nonconformity or other undesirable situation.” There can be more than one cause for non-conformity. Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence. There is also a slight distinction between correction and corrective action. A correction is an “action to eliminate a detected non-conformity.”

So, a correction can be, for example, rework or regrade. Preventive action is defined as “action to eliminate the cause of a potential non-conformity or other undesirable potential situation.” As with corrective action, there can be more than one cause for a potential non-conformity. Implement solutions that not only correct the immediate problem but also prevent the problem or any related problems or issues from occurring again.

Ascertaining the Root Cause

Identifying the root cause of a defect or non-conformity can be challenging, but it must be found and confirmed in order to avoid future repeat of the concern. If an incorrect root cause is identified, it is inevitable that an incorrect solution will result. There are several tools available for quality professionals to employ in root cause analysis:

–         Fishbone Diagram

–         Fault Tree Analysis

–         Pareto Analysis

–         Five Whys Model, developed by Toyota

–         Failure Mode and Effects Analysis (FMEA)

In order to have an effective CAPA methodology, companies must:

–         Have proper controls on the production processes

–         Train employees in the Quality Management System & Quality System Regulations

–         Ensure that CAPA methodologies are considered a value-added activity

–         Ensure that root cause analysis procedures are standardized across all activities

 

Depending on the maturity of a CAPA system, it may take some time to get it into the shape it should be. Bear in mind that a good way to start is by improving any critical deficiencies first. A company’s CAPA system gets to the heart of all its employees’ ability to think critically, to the quality and caliber of its Quality Assurance staff, and to the organization’s commitment to delighting its customers. Remember that most quality standards require the use of CAPA methodology, with traceable documentation.

BLURB

In ISO 9000 standards, corrective action is defined as ‘action to eliminate the cause of a detected nonconformity or other undesirable situation.’ There can be more than one cause for non-conformity. Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence. There is also a slight distinction between correction and corrective action. A correction is an ‘action to eliminate a detected non-conformity.’

 

ENDS

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