Thursday, December 3, 2015

DEMYSTIFYING CORRECTIVE ACTIONS AND PREVENTIVE ACTIONS IN ISO 9001 AND RELATED MANAGEMENT STANDARDS

As a Quality Assurance or Management professional, you are aware that ISO 9001 has been used by numerous other standards to provide a base for additional requirements relating to the particular industry or environment that the particular standard is written for. 

The figure below has been reproduced from ISO 9001:2008 / ISO 9001:2015 standard. The figure distils the entire standard into one picture, proving once again that a "picture is worth a thousand words" (maybe many thousands of words). In my opinion, the figure also points to the real purpose of the use of the standard, and essence of all the requirements: the final requirement is that the management system must continually improve. 


A study of the standard also points to section 8.5 as the final requirement, both in the placement of the requirement, as well as the purpose of the Standard as a Business Process model. 

Somehow, there is a lot of confusion surrounding CAPA, starting with the first version of ISO 9000 series of standards published in 1987, and continuing to the current (2008) version. In this White Paper, I will show how to clearly differentiate between the two, and also take the bold step of re-writing section 8.5 in a manner that should reduce/ remove the confusion. 

It is important to remember that a Corrective Action is in reaction to an event or a cause, such as, a customer complaint, nonconformity, either by product or a result of audit, or discovered through product and process monitoring. 

A Preventative Action is proactive in nature, in that it is undertaken before an event or nonconformance has occurred. This process is used to discover and determine potential discrepancies (beforehand) and work to ensure that that particular event does not occur, preferably forever. 

Drilling down into 8.5 brings us to the engine of continual improvement: 8.5.2 and 8.5.3--Corrective Actions and Preventive Actions. A good acronym is CAPA. Please note, all improvement technologies (Six Sigma, TOC, et-al) fit nicely into CAPA. 

A careful perusal of 8.5.2 and 8.5.3 (Corrective Action and Preventive Action) shows that the steps are very similar. Semantics aside, the main difference between the two sections is that Corrective Action requires a determination of the causes of a nonconformity or a root cause analysis, used to identify the cause of a nonconformity or a deviation in production and offers suggestions of the appropriate Corrective Actions to undertake. 

In addition, the end result or goal of the sections is the same: prevent a problem in the future. The only difference is how the problem is discovered and identified. In the case of Corrective Action, it is discovered by experiencing it. In the case of Preventive Action, the problem is forecast to happen-- there is reason to believe that the problem might happen, even though it has not happened yet. 

Much of the confusion between the two sections is attributable to the defining language of each being so similar but the undertaking of the actions is disparate and distinctive. Because of this, I have created a new “workflow” diagram of the 8.5.2 and 8.5.3 section of the Standard, as shown below. This is a rearrangement of the requirements in the standard, for the purpose of providing a framework for implementation that would be simple, clear, and eliminate repetition of procedures (for example, have two separate procedures, one for 8.5.2, and the other for 8.5.3). 

The text shown below captures requirements of both 8.5.2 and 8.5.3 and it eliminates the need to differentiate between actual and potential nonconformities. CAPA addresses process improvement as deemed necessary by management. The emphasis should be on the process of executing steps a) through f) with a lot of rigor and vigor.
8.5 Improvement
8.5.1 Continual improvement
The organization shall continually improve the effectiveness of the quality management system through the use of the following subsystems: 
      1. Goal Setting: This shall at a minimum, include the following: 
            a. quality policy 
            b. quality objectives 
      2. Measurement and Analysis: This will furnish data with which to assess performance of the quality management system, and shall at a minimum, include the following: 
            a. Comprehensive measurement of the quality system through audits. The assessment shall be against the quality policy, applicable standard(s), and regulations. 
            b. Analysis of data which should at a minimum measure performance against the individual quality objectives. 
      3. Corrective and Preventive Actions (CAPA): A rigorous and disciplined method will be used to design/ redesign/ adjust business processes to prevent the reoccurrence or occurrence of actual or potential nonconformities against objectives for product, or processes. 
      4. Management Review: Periodic reviews of the quality management system will be conducted by top management to assess amongst others, the above subsystems, and to provide direction with the goal of continual improvement for the future. See section 5.6 of ISO 9001:2008 / ISO 9001:2015 for details.
8.5.2, 8.5.3: Corrective Action/ Preventive Action (CAPA)
The organization shall take action to eliminate the causes of nonconformities, both those that have actually occurred and those that can potentially occur, in order to prevent their recurrence/ occurrence in the future. CAPA shall be appropriate to the effects of the nonconformities under review. A documented procedure shall be established to define requirements regarding both actual and potential nonconformities for: 
      a) Reviewing nonconformities (including customer complaints). 
      b) Determining the causes of nonconformities. 
      c) Evaluating the need for action to ensure that nonconformities are prevented in the future. 
      d) Determining and implementing action needed. 
      e) Records of the results of action taken (see 4.2.4), and 
      f) Reviewing the effectiveness of CAPA taken. 

In summary, the above described approach clarifies the differences of corrective actions and preventative actions by combining the similarities and emphasizing the differences in a method that is easier to use and more efficient in its content and presentation, and, hopefully, relieves some of the stress and confusion related to CAPA and its “twin” protagonists.DEMYSTIFYING CORRECTIVE ACTIONS AND PREVENTIVE ACTIONS IN ISO 9001 AND RELATED MANAGEMENT STANDARDS

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