Corrective Action and Preventive Action

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CAPA: Corrective action and Preventive Action - the ISO 9001 Standard requirements

The requirement for corrective action (the CA - CORRECTIVE ACTION from the CAPA) is included within chapter 8.5 – Improvement. Within the most basic requirement, the objective of the corrective action is to:
  • Eliminate problems/Nonconformities
  • Achieve improvement within processes
In this article we will review only the requirements for CA (corrective action) from the CAPA. The PA (preventive action) would be reviewed within another article.
The organization is required to take actions to eliminate Nonconformities that had occurred - this is improvement. Why? Something went wrong; you detected it, eliminated it and made sure it would not happen again. How to achieve? With the CA (form the CAPA). The ISO 9001 Standard requires you to document the cand the following treatment. The purpose is to prevent it from happening again. You must not document any small fault that happens - In this case you would turn into ISO 9001 secretaries - but the major ones that affect the product (or the service) and its quality. You must document Nonconformities in order for them to be introduced it into a process that his objective at the end is to eliminate the Nonconformity forever!! And yes, you are required to maintain a procedure describing the process of eliminating the Nonconformities and to document the process itself. It is not a recommendation but a requirement.
NON CONFORMITIES DOCUMENTATION - (Dealing with Nonconformities is a whole subject on its own that would be dealt in another article - For now we will review it shortly)

As soon as Nonconformity is detected within the organization, it must be recorded. It must be written somewhere. The purpose is for a later investigation about the root cause of the Nonconformity and to verify elimination. This is one of the ISO 9001 Standard required quality records. The record can appear in any form: form, software, e-mail, whatever appropriate for your organization. But bear in mind that this documentation is the first step of the corrective action process. Thus, it is recommended to document it where you would be able to trace and document the next steps. The first documentation is also the primary information gathering about the Nonconformity. By the way, customer's complaints are considered as Nonconformities.
We recommend you to document any characteristic of the product (or the service) where you detected the Nonconformity. Why? Because when you can examine all the characteristic of the products you would be able to understand the Nonconformity better, you would be able to understand the cause and far more important, you may come up with an efficient corrective action.The Nonconformity record – which details require documentation:
  • The Nonconformity details – you are required to document any identifying details regarding the Nonconformity: customer's name, product's name catalogue number, name of the employee that detected the Nonconformity – any information that would help you to investigate the Nonconformity latter on. Another way to look at it, document the product's characteristics.
  • Description of the Nonconformity – you can put here a literal description or even attach another document. Whatever suits your organization.
  • Categorization of the Nonconformity – it is not required by the ISO 9001 Standard but it is highly recommended. The categorization would assist you later with a statistical analysis and an over view regarding the nonconformities.
  • Investigation Details – any Nonconformity must be followed with an investigation. The purpose of the investigation is to identify the cause for the Nonconformity. This is the essence of the corrective action.
The subject isn't that complex. You have to follow some basic minimal requirements of CAPA and you are there.
Corrective action description – after you identified the root cause for the Nonconformity, you are required to initiate an action to eliminate it: The corrective action. Why must you document it? For supervision. After a defined period of time (documented within the procedure) you must examine whether the corrective action was sufficient, effective and the Nonconformity did not occurred again.
Corrective action objectives – you must define what is required by the corrective action taken. The objective could be a numerical, quantitative or a quality requirement – whatever is appropriate for the case. It is not a recommendation but an ISO 9001 Standard requirement.
Closing date for the corrective action – All corrective actions should be limited within time frame in order to measure its effectiveness. You performed a corrective action. That is good but not enough. According to the ISO 9001 requirements, you must define time frames (according to your needs) to examine its effectiveness. The date indicates when the corrective action would be examined.
The corrective action results – the ISO 9001 Standard requires you to observe the corrective action taken and to verify its objectives. You must indicate (and document) the status of the corrective action. You must document what are its results: success, failure or perhaps more time is required to examine its effectiveness - that is also possible. Then and only then, you may close the corrective action. When a corrective action was found as not successful it is recommended to open a new one. It is not required by the ISO 9001 Standard but an unsuccessful corrective action indicates an open Nonconformity –and that is forbidden by the ISO 9001 Standard. And you know it.
We remind you again; you must maintain a documented procedure defining the process of corrective action:
  • Locating the Nonconformity
  • Where and how to document it
  • The investigation
  • The action taken and
  • The closing of the corrective action

This procedure will one of your Quality procedures required to maintained by the ISO 9001 Standard.

You must also maintain documentation of the process itself:
  • The nonconformity detected
  • The cause
  • The corrective action taken
  • Its objectives (including time frames)
  • The results
So, two documentations are required; a procedure and the process itself. We refer you to the next site: - they provide an effective template solution that holds against the ISO 9001:2008  Standard requirements. Give them a try.

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