Correction, Corrective Action and Preventive Action

These three words have been widely discussed among the Quality community. For beginners, these are really confusing terms and especially not very popular with the Regulators. Very often Corrective Action and Preventive action are used with the same sense.
According to the ISO 9000 – Quality Management Systems – Fundamentals and Vocabulary the following are the definitions.
Preventive Action : (3.6.4) – Action to the eliminate cause of potential Nonconformity or other potential undesirable situation.
The word to notice here is the Potential. This means that the nonconformity has not occurred or  detected. This action is taken pre- problem.Though this is not a perfect example, this can explain the terms. A water pipe is likely to break and leak. Here the problem is not occurred but it is identified that it is likely to occur. The action may be reducing the pressure in the pipe, replacing the pipe or anything else. Even in this case the causes are found and the causes are addressed.
Preventive actions are proactive, continuous and targeted actions to reduce the instances of Corrections and corrective actions
Corrective Action (3.6.5) : Action taken to eliminate the cause of the detected Nonconformity or other undesirable situation
Correction(3.6.6) : Action taken to eliminate a detected  Nonconformity
In the cases of correction and corrective action, the noticeable word is “detected”. These actions are taken after the occurrence of the problem. Again taking the example of water pipe, the problem in this case will be the water pipe is broken or leaking” . The action to be taken in this case has be in two parts. 1) Correction : Repair the pipe or arrest the leak. This stops the leak. However this does not solve the problem. 2) The next action needed is corrective action: Find the cause which has led to the problem of leak and eliminate the cause. In this case the cause may be faulty pipe, or High pressure in the pipe, or any other or a combination of these. The problem can only be solved only if all the causes are eliminated.
There can be cases where correction not possible and only corrective action can be made. For example the pipe is broken.
The words correction, corrective action and preventive action are a little bit confusing but if used carefully, they convey very good meaning.
Preventive actions contribute to cost efficiencies, and timely delivery of the product which leads to customer satisfaction.
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Originally posted 2011-04-24 05:38:00.

documents required for ISO 9001 : 2008

To be in compliance with ISO 9001:2008, the organization must have some mandatory documents. These requirements are stated under various clauses of ISO 9001:2008. The documents required for ISO 9001 are listed below.
According to ISO 9000 (QMS Fundamentals and Vocabulary), A Document is defined as “Information and its supporting medium“. This is further explained in the notes to this definition.
The medium can be paper, magnetic, electronic or optical computer disk, photgraph or master sample or combination there of.
A set of documents is called as “Documentation
The requirements of documentation for compliance with ISO 9001:2008 are as follows.
The following Clauses define the documentation requirements in the Quality Management System
4.21. General
The Quality Management System Shall Include the following documentation
(4.2.1 a)  – A documented Statement of Quality Policy
( 4.2.1 a)  – A documented Statement of Quality Objectives
(4.2.1 b)  – Quality Manual
(4.2.1 d)  – The documents including records which are to be determined by the organization as necessary for effectiveness of its QMS
(4.2.1 c) In addition to the above, the Standard identifies some documents and records which are identified under different sections of the standard
To meet the requirement of 4.2.1 c, we need to scan through the standard for further requirements. This will be found as follows.
( 4.2.3 ) A documented procedure to define the document control
(4.2.4 )  A documented Procedure to define the controls needed for various records
(8.2.2)  A documented procedure to define the responsibilities and requirements regarding internal audit.
(8.3) A documented procedure to define the control of non-conforming product
(8.5.3) A documented procedure to define the requirements concerning the Corrective Action
(8.5.4) A documented procedure to define the requirements regarding Preventive Action.
To comply with these requirements, documented Procedure means  that the procedure is established, Documented, implemented and Maintained.
The Documentation requirements can be covered in more than one document, and a single document may address one or more requirements.
All these documentation requirements may or may not be part of the Quality Manual. Where these are not part of the Quality Manual, The reference to these procedures must be provided in the Quality Manual.
Please note in addition to the requirements listed above, the organization may require some additional documents which may or may not be part of Quality Manual.

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Originally posted 2011-04-19 16:42:00.

Introduction to AS 9100

Introduction to AS 9100
AS 9100 is the most accepted, adapted and standardized Quality Management System (QMS) Standard, addressing the requirements of Aerospace Industry.
History of AS 9100
During the decade of Nineties, Aero Space Industry does not have a standard requirement of QMS. Each major organization has a basic requirements of ISO 9000 and developed its own documentation/Specific Standards. One such Standard is D1-9000 used by Boeing to evaluate its suppliers. The other contractors have developed their own supplementary standards.This has resulted in difficulties in enforcing or compliance issues.
This has resulted in Major Aerospace Contractors coming together to set up a Single, Unified QMS Standard Acceptable to all of them. This is released as AS 9000, by the Society of Automotive Engineers (SAE) in 1999.
The relation to ISO 9000 Came in 2000, when the rewrite of ISO is being undertaken for its 2000 version. This time AS Group worked closely with ISO and the standard is based on ISO 9000 family of standards and principles. The additional requirements of safety and Regulatory requirements are added.
The current revision of AS 9100 is Rev C which has been released in Jan 2009. This revision incorporates compatibility with the latest ISO Standard ISO 9001:2008 and some additional requirements specific to defense aviation are added.
The AS Family of Standards
AS 9100 :  Quality Management Systems – Requirements for Aviation, Space and Defense Organizations.
AS 9110 : Quality Management Systems – Requirements for Aviation Maintenance Organizations
AS 9120 :  Quality Management Systems – Requirements for Aviation, Space and Defense Distributors.
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Originally posted 2011-04-19 02:03:00.

ISO 9001 and Certification

As said in an earlier article, ISO does not itself certify organizations or the bodies which certify.
Organizations are certified by the Certification bodies. These Certification bodies are authorized by the accreditation bodies  of the country to audit the  organizations applying for ISO 9001 compliance certification. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the Accredited Certification Bodies (CB) are accepted worldwide.
Although commonly referred to as ISO 9000:2000 certification, the actual standard to which an organization’s quality management can be certified is ISO 9001:2008. The applying organization is assessed based on an extensive sample of its sites, functions, products, services and processes; a list of problems (“action requests” or “non-compliance”) is made known to the management. If there are no major problems on this list, or after it receives a satisfactory improvement plan from the management showing how any problems will be resolved, the body will issue an ISO 9001 certificate for each geographical site it has visited.
An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually around three years.
There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the method and model of quality management described in the standard), or it is not
Both the accreditation bodies and the certification bodies charge fees for their services. Various charges paid by the organization audit fees, surveillance audit fees, re certification audit fees.
In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved.
ISO 9001 is not in any way an indication that products produced using its certified systems are any good. A company can intend to produce a poor quality product and providing it does so consistently and with the proper documentation can put an ISO 9001 stamp on it.
form the above it can be observed that the certification of ISO 9001 compliance does not guarantee the product quality. It simply means that the organization has a quality management system, which is in conformance of the ISO 9001 Standard and implemented the QMS which is good for producing a good quality product.
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Originally posted 2011-04-09 14:31:00.

What is the history of ISO 9001

The Previous Standards
If you track the history of ISO 9001 standards, the first initiative can be traced back to 1959, when Department of Defense published its MIL-Q-9858 Standard.
This MIL Q-9858 has been revised into NATO APQP Standards in 1969. Then the Civil Version is initiated by BSI, and published the BS 5179 guidance standards in 1974. Further this is revised into BS 5750 series of requirements Standards in 1979.
The First Version of ISO-9001 : ISO Started to work on these standards in 1981 and finally published the first version of ISO 9001:1987 retaining the same structure as BS 5750, in 1987.  This Standard has three different versions ISO 9001, ISO 9002, ISO 9003.
ISO 9001:1987 – Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
ISO 9002:1987 – Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
ISO 9003:1987 – Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
The emphasis in this version tended to be placed on conformance with procedures rather than the overall process of management—which was the actual intent.
The Version ISO 9001:1994 : ISO published this version in 1994 and the major change is that it emphasizes Quality Assurance via preventive actions, instead of just checking the final product. The requirement of documented procedures is also emphasized even though this is same in the previous version.
The Version of 2000 :  ISO 9001:2004 is significantly different from the previous versions. the most important of this is the emphasis on process management. Also this version demands the involvement of top management,review of process performance, continual improvements to the quality system, monitoring of Customer satisfaction etc.
Another significant change is the integration of ISO9001, ISO 9002 and ISO 9003 into a single standard and calling it ISO 9001.There is a provision to exclude some clauses of design and development if the company is not involved in these activities.
The Version of 2008 : Released in Feb 2008, this version only introduces clarifications to ISO 9001:2000 and some clarifications to improve compatibility with ISO 14000:2004. These changes are included in the ISO 9001:2008.

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Originally posted 2011-04-08 04:00:00.

What is ISO standard

ISO (International Organization of Standardization) is the worlds largest developer and publisher of International Standards or ISO standard
Note: ISO is often wrongly called as International Standards Organization. This is wrong. It is not an abbreviation. This is a word from Latin meaning Equal. The background goes that ISO is a multi Language organization. to avoid confusion between languages, the Latin word is chose. Irrespective of Language, the name of the organization is ISO.
The Headquarters of this organization is located Geneva, Switzerland. It is not a Government Organization. It is a association of 160 national Standards Organizations and they are called as “member bodies”. Though ISO is non governmental, Its members may be part of their National Government. The most representative organization of the country is chosen as a member of the organization, and only one from each country can become a member. See the list of members Here.
There are other members called as Correspondent Members and Subscriber Members.
The role of ISO is limited to specify the requirements for products, Services, good conformity assessment, Managerial and organizational practices. ISO is not involved in certification nor has any control over the certification business.
The standards developed by ISO are designed to be implemented worldwide.
The most popular of ISO Standards are ISO 9000 Family on Quality Management Systems and ISO 14000 Family on Environmental Management Systems.
ISO 9000 forms basis for many other industry specific Standards like TS16949 for automobile Industry, ISO 17025 for Laboratories and AS 9100 for Aviation Industry. 
These are few examples of industry specific Standards only.
Also ISO has provided standards for Various Processes too. There are specific Standards for processes such as Risk Management, Configuration management Etc.
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Originally posted 2011-03-19 04:21:00.

What is Standard

If you go by the dictionary, the word standard is defined as the following in the popular dictionaries
Oxford defines ‘Standard’ as a level of quality or attainment:a required or agreed level of quality or attainment:something used as a measure , norm, or model in comparative evaluations:used or accepted as normal or average:
Merriam-Webster’s defines ‘Standard’ as Set up and established by authority as a rule for the measure of quantity, weight, extent, value, or quality
The Standards are developed by various organizations. Most Nations have their own standardization bodies. The standards are mainly under two categories. Product Standards and industry Standards.

Product Standards

Product Standards define the minimum requirements for a product to be called as a standard product. These are normally defined by the statutory authorities such as Bureau on Indian Standards (BIS). Each of the product will have its own standard defined and  the product is marked.

Industry Standards

Industry Standards are based on the requirements of the industry. The most acceptable Standards are developed by ISO (International organization for Standardization). Out of the 18000+ standards developed by ISO, ISO 9000 family is the most widely used. All most all activities are covered by ISO.

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Originally posted 2011-03-19 02:54:00.