Corrective action – the ISO 9001 Standard requirements
Finagle’s Fourth Law: Once a job is messed up, anything done to improve it makes it worse.
The requirement for corrective action (the CA – CORRECTIVE ACTION out of the CAPA) is included within chapter 8.5 – Improvement. Within the most basic requirement, the objective of the corrective action is to:
- Eliminate problems/Non conformities
- Achieve improvement within processes
In this article we will review only the requirements for the corrective action. The preventive action will be reviewed within another article. The organization is required to take actions required to eliminate Non conformities that had occurred. This is considered as improvement. Why? Something went wrong; you systematically detected it, eliminated it and ensured that it would not happen again by implementing a method or introducing the issue to controlled process. The ISO 9001 Standard requires documenting certain details and following the progress. The purpose is to prevent the nonconformity from happening again. You must not document any small fault that occurs – in this case you would serve the ISO 9001 instead of it serving you. You do though need to document 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 controlled process with the objective 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 Conformioty Documentation
(Dealing with Non conformities 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 early information gathering about the Nonconformity. By the way, customer’s complaints are considered as Non conformities. We recommend you to document any characteristic of the product (or the service) upon which you detected the Nonconformity. Why? Because when you can examine all the characteristic of the products you will be able to understand the Nonconformity better, you would be able to understand the root cause and far more important, you may come up with an efficient corrective action. The Nonconformity record – which details are required to be documented:
- 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 enter here a literal description or even attach another document. Whatever suits the nature of 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 non conformities.
- Investigation Details – any Nonconformity must be followed with an investigation. The purpose of the investigation is to identify the root cause for the Nonconformity. This is the essence of the corrective action.
The corrective Action Documentation
The matter is not complex. You must follow some basic minimal requirements of CAPA and you have it under control.
- 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 on a procedure) you must examine whether the corrective action was sufficient, effective and the Nonconformity did not reoccur.
- Corrective action objectives – you must define what the objectives of the corrective action are. The objective may be a quantitative or a qualitative – whatever is appropriate for the case. Setting objectives is not a recommendation but an ISO 9001 Standard requirement.
- Closing date for the corrective action – All corrective actions should be limited within a defined time frame in order to measure its effectiveness; you performed a corrective action, which 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 will indicate when the corrective action would be examined.
The corrective action results or outputs – the ISO 9001 Standard requires you to observe the corrective action taken and to verify its achievement of 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 method in which you will conduct the investigation
- How action will be documented
- How you will verify and close the corrective action
This procedure will serve as one of your Quality procedures required to be maintained by the ISO 9001 Standard. You must also maintain records of the process itself:
- The nonconformity detected
- The cause
- The corrective action taken
- Its objectives (including time frames)
- The results
So, there are two types of documentations ; a procedure and its outputs. I refer you to the next site: QualiytManualTemplates.com – they provide effective templates and solutions that answers the ISO 9001:2008 Standard requirements for documenting the corrective action process. Give them a try.
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