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.

Quality Assurance and Quality Control

Quality assurance and quality control are often used interchangingly by error. these two are different terms and have different meaning.
Quality Control (QC):
►“The operational techniques and activities that are used to fulfil requirements for quality” (ref: ISO 9000)
►QC is an inspection function.
►QC requires the performance of the necessary observations, testing & documentation that verifies the work performed meets or exceeds requirements.
Quality Control makes sure the results of what you’ve done are what you expected.
The processes of quality control involve calibration, sampling and documenting reviews.
Quality Assurance (QA)
►“All those planned and systematic activities implemented to provide adequate confidence that an entity will fulfil requirements for quality” (ref: ISO 9000)
►QA is an audit function, used to verify that QC is being performed and performed effectively & efficiently.
Quality Assurance makes sure you are doing the right things, the right way.
Measurement is a vital aspect of Quality Assurance.
The Quality Assurance is to do with standards, processes, and policies are in place and carried out; to recommend and implement improvements to them, and to ensure that the people that need to know about them know about them. QA “audits” or “reviews” are intended to determine the efficacy of these processes, and policies.
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Originally posted 2011-04-06 01:20:00.

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.

Cost of Quality

  The term Cost of  Quality (CoQ) is generally misunderstood as the cost to create a quality product or service. The real definition of this term is the cost incurred by not creating a quality product or service.
What can be included in cost of Quality (bad Quality)
Cost of Quality includes the cost to the organization to rectify the non conforming product or service. This includes following example
Cost incurred in reworking of a manufactured item, the men, Material and other resources.

costs incurred in skipped delivery schedules, the penalties etc.

Cost incurred in retesting of an assembly, rebuilding of a tool.
The correction of a bank statement.
The reworking of a service, such as the reprocessing of a loan operation or the replacement of a food order in a restaurant.
Warranty Claims
The biggest cost incurred by an organization on account of poor quality is the loss of customer loyalty.
In short, any cost that would not have been expended if quality were perfect contributes to the cost of quality.

The cost of Quality is only a part of Total Quality Costs which includes the following
The costs incurred by
Investing in the prevention of nonconforming to requirements.
Appraising a product or service for conformance to requirements.
Failing to meet requirements.(Cost of poor Quality (COPQ))
The details which can be included in Total Quality Costs
Prevention Costs
The costs of all activities specifically designed to prevent poor quality in products or services.
Examples are the costs of: New product review, Quality planning , Supplier capability surveys, Process capability evaluations, Quality improvement team meetings, Quality improvement projects, Quality education and training
Appraisal Costs
The costs associated with measuring, evaluating or auditing products or services to assure conformance to quality standards and performance requirements.
These include the costs of:  Incoming and source inspection/test of purchased material, In-process and final inspection/test, Product, process or service audits, Calibration of measuring and test equipment, Associated supplies and materials
Failure Costs
The costs resulting from products or services not conforming to requirements or customer/user needs. Failure costs are divided into internal and external failure categories.
Internal Failure Costs : Failure costs occurring prior to delivery or shipment of the product, or the furnishing of a service, to the customer.
Examples are the costs of: Scrap, Rework, Re-inspection, Re-testing, Material review, Downgrading
External Failure Costs : Failure costs occurring after delivery or shipment of the product — and during or after furnishing of a service — to the customer.
Examples are the costs of:  Processing customer complaints, Customer returns, Warranty claims, Product recalls,
Total Quality Costs:
The sum of the costs listed above. This represents the difference between the real cost of a product or service and what the reduced cost would be if there were no possibility of substandard service, failure of products or defects in their manufacture.

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Originally posted 2011-04-02 04:46:00.