QIA is presenting a series of articles to help people understand important concepts in Quality Management. These will be grouped under different topics:
Topic 1: Continuous Improvement Level 1. This will consist of the following articles:
- Dangers in Poor Corrective Action Systems
- When and How to Process Corrective Actions
- Powerful Nonconformance Control Systems
- Your Basic Continuous Improvement System
We will invite you to read an article approximately every other week. Hope you will enjoy these.
Background:
Even though the ISO 9000 series of standards has been around for more than thirty years, a fair amount of confusion or mystery still surrounds the topics of Corrective Actions and Corrections. Unfortunately, in the day-to-day usage of the terms, corrections and corrective actions are interpreted as synonyms, and this is one of the sources of the confusion. This confusion can result in designing CAPA management systems that are not as effective as they could be in ensuring that the organization always provide conforming product to customers.
The key to understanding the difference is that Corrections are aimed at the Product (including service), and Corrective Actions are aimed at the Process (es) that produced the product.
The Confusion:
a) A “30,000 foot” views of the Quality Management Standard ISO 9001 shows a document that provides a model to help organizations to consistently produce conforming products. It also recognizes that nonconformities (nonconforming products) can occur. When they do, those must be handled according to requirements for section 8.7 (Control of Nonconforming Outputs) to ensure that nonconformities are corrected, and the nonconforming product (NCP) is not used as if it is conforming product.
The first confusion is that many people feel compelled for various reasons to take corrective action against all nonconformances that are detected during conduct of business. The two principal misinterpretations causing this course of action are:
1. The Standard requires it (it does not).
2. The standard may not require it, but it is the best way to ensure that all problems are eliminated forever (not an effective or wise business policy).
b) For the first misinterpretation: the QMS standard in section 10.2(b) requires the organization to evaluate the need for action to eliminate the cause(s) of the NC, in order that it does not recur, by:
1) reviewing/analyzing the NC
2) determining the cause
3) determining if similar NC’s exist or could occur, and
10.2.(c) implement any action needed and,
10.2.(d) review the effectiveness of any corrective action taken.
The Solution
This therefore gives Management the freedom and responsibility to assess the degree of the risk posed by a possibility that the nonconformance under review may repeat in the future. So, therefore, if the risk and its effect are minimal or negligible, then it will be quite appropriate to not take any corrective action at all. It will be quite appropriate to depend on the same mechanisms designed to detect nonconformance to detect it again when it happens and take actions of correction to correct the nonconformities per section 8.7 (Control of Nonconforming Output).
The important fact is that proper corrective actions require deliberate and involved actions to research causes (root cause, contributing cause, and direct cause) and redesign, and improve underlying processes. This involves expenditures beyond and in addition to just correcting the nonconforming product and should be invoked only when the assessed value of the risk is greater than the cost of implementing a corrective action. This is good business, and fully supported by the Standard.
c) A corollary to the argument in the above paragraph is that care should be taken to elevate corrective actions to a level that is clearly higher than taking action to correct nonconforming products. Corrections include repair and rework, and clearly are focused on the product, while Corrective Actions are focused on the process that produces the product. Forcing corrective actions on all nonconformities usually end up in just stating the correction as a corrective action, and the spirit of corrective actions is lost. It is like “crying wolf”, and when the big problems do happen, the culture and mechanisms in place do not do a good job of ensuring that the problem is really prevented in the future. Each Corrective Action should be viewed and handled as full-blown project in Continual Improvement of relevant business processes.
It is therefore important to keep that part of the Nonconformance’s quality management system (QMS) that handles corrections to products, separate from the part that addresses process re-design and improvement that produces the products. Of course, there is a link. Nonconformance’s that pose a significant risk should be investigated to ensure that they never happen again (prevention from recurring). This involves corrective action(s).
Conclusion
A Quality Management System is a very powerful part of the overall operation of an organization. The most important part of it is the Continual Improvement subsystem that should run in the background in a pervasive manner. In its simplest form, it consists of looking for risks, and selecting the significant ones, and mitigating them. Mitigation consists of finding the causes, which are the processes that contribute to the risk, and eliminating or minimizing those risks.
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