Statistics - 1 - What is Statistics ?

Statistics can be described as a quantitative method of scientific investigations.

If used as  plural noun 'Statistics' means the numerical data arising out of any sphere of human experience.

Used as singular 'Statistics' is the name for the body of scientific methods used for collection, analysis, Organizing, and interpretation of Numerical data.

According to American Statistical Association 'Statistics is the scientific application of mathematical principles to the collection, analysis, and presentation of numerical data'

Also, There is a different meaning for the word 'Statistic' in the field of Statistics(subject). In this sense A 'Statistic' is a numerical item which are produced by the some calculations using the data. Standard Deviation, Mean etc are called as 'Statistic'  in this sense.

This is one arm of Mathematics, which is extensively used in all most every field. Statistics has become an important tool in the work of many academic disciplines such as medicine, psychology, education, sociology, engineering and physics, just to name a few. Statistics is also important in many aspects of society such as business, industry and government. Because of the increasing use of statistics in so many areas of our lives, it has become very desirable to understand and practice statistical thinking. This is important even if you do not use statistical methods directly.

Even with so many uses, there is some mistrust in public about statistics. This is because of the misuse of the figures by the people for their convenience. It is often said by people that statistics can prove any thing. During the introduction to the course i joined on statistics, this statement is used. There are 3 types of statistics. 1 - Lies, 2- damned Lies 3- Statistics. We will teach you the 3rd part here.

Used properly statistics is a panacea for all the problems faced by the world. it can be a tremendous tool for the growth of any organization. 
Visit the next post Data Collection - Types of Data

What are the compulsory Records needed to be maintained to be in compliant with ISO 9001:2008

What is a Record?
According to ISO 9000:2005, Record is defined as a document stating results achieved or providing evidence of activities performed.
Records shall remain legible, readily identifiable, and retrievable according clause 4.2.4 of ISO 9001:2008.
The Records maintained by the organization are to be controlled. 
Clause 4.2.4 deals with control of records
ISO 9001:2008 requires some records to be maintained mandatory. A statement saying "records shall be maintained" (See 4.2.4) against various clauses for identifying them.
The Mandatory records to be in complaint with ISO 9001:2008 are 

1. Records from Management Reviews (5.6.1)
2. Appropriate records of Education, Training, Skill and Experience for personnel performing work (6.2.2)
3. Records which can provide evidence that the realization process and the resultant product meets the requirements (7.2)
4. Results and actions arising out of review of requirements related to the product  (7.2.2) (For eg Sales Records)
5. Design and development inputs relating to the product (7.3.2)
6. Results and actions arising out of the review of design and development m(7.3.4)
7. Results and actions arising out of verification of design and development (7.3.5)
8. Results and actions arising out of validation of design and development (7.3.6)
9. Results and actions arising out of review of design and development changes (7.3.7)
10. Results and actions arising out of evaluation of suppliers (7.4.1)
11. Records to demonstrate validation of special processes (7.5.1)
12. Records of unique identification of the product  (where traceability is a requirement) (7.5.3)
13. Records of information to the customer in case the customer property is lost, damaged or otherwise found to be unsuitable for use (7.5.4)
14. Validity of the previous measuring results when measuring equipment is found to be out of calibration
15. Results of calibration and verification of the monitoring and measuring equipment (7.6)
16. Records of basis used for calibration or verification of monitoring and measuring equipment in case of absence of  specified standards (7.6)
17. Records of audits and their results including follow up actions (8.2.2)
18. Records of person(s) authorizing release of product for delivery (8.2.4)
19. Records of product non-conformities and the subsequent actions (8.3)
20. Results of corrective action (8.5.2)
21. Results of preventive action (8.5.3)

In addition to the records listed above, the organization may decide to maintain additional records but it is always advisable to maintain the record maintained are  simple

Also Note that the records can be combined where appropriate and also maintain a record in one or more parts. 

What are Principles of Quality Management Systems

The function of Top Management include Management of Quality Management along with other disciplines. To succeed in Business, the top management can utilize the quality management principles identified by the International Standards like ISO 900 Family. The Same principle apply for the other standards like AS 9100, TS 16949 which are supplement to ISO9001. They are

Customer Focus

The Organization depend its our customers and therefore should understand the current and future customers’ needs, should meet their requirements, and strive to exceed their expectations.

The organization must ensure that:

Customer needs & expectations are determined

Customer needs are converted into specific requirements

Customer requirements are fulfilled with the aim of “exceeding” expectations to “enhance” customer Satisfaction.

Customer Satisfaction : Customer’s perception of the degree to which the customer’s requirements have been fulfilled”(Ref: ISO 9000:2000, 3.1.4)

Customer Complaints are a common indicator of low customer satisfaction, but their absence does not necessarily imply high customer satisfaction. Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.Research shows that fewer than 5% of dissatisfied customers actually complain.

Leadership

Leaders establish a unity of purpose and the direction of the organization.  They must create and maintain the internal environment in which all employees can become fully involved in achieving the organizations objectives. There is a need for “Top Management” to play an active role in the operation & performance of the QMS.

“Top Management” involvement in the implementation & improvement of the QMS will be checked by external auditors.

Involvement of People

People at all levels are the essence of the organization and their full involvement enables their abilities to be used for the organization’s benefit. the most valuable assets of an organization is its Human Resources. The organization should create an internal environment for people at all levels feel the ownership of their task and improving it to achieve the desired customer satisfaction.

Process Approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

What is a “Process”? : “an activity using resources and managed in order to enable the transformation of inputs to outputs”. Often the output from one process directly forms the input to the next.

Systems Approach to Management

Identifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives. Though this term looks similar to the previous one Process approach, there is distinct difference between them. to Identify clearly, “A set of processes interacting symmetrically will become a system”.

continual Improvement

Definition : Recurring activity to increase the ability to fulfill requirements (ref. ISO 9000:2000, 3.2.13)

The organization Shall strive to enhance its overall performance and this should be a permanent objective of the organization. There is a scope for everyone in the organization to Working in the business ( doing their Job) and Working on the business(improving the efficiency)

Factual Approach to Decision Making

Appropriate data should be identified, gathered and analyzed for trending and tracking in order to provide opportunities for improvement. This will lead to effective decision making.

Mutually beneficial Supplier Relations

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

If an organization buys in poor (good) quality, it can negatively (positively) affect the organization’s performance.

The above principles identified by the ISO 9000 Family of standards as the basis for any Quality Management Systems.

If these principles are used effectively, the organization will have a sound quality management system and will lead to success.

What are the compulsory documents needed for compliance with 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. 

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 complaince with ISO 9001:2008 are as follows.

The follwoing 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 reuirement of 4.2.1 c, we need to scan through the standard for further requirements. This will be found as follws.

( 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 produre 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) Ad coumented procedure to define the requirements regarding Preventive Action.

To comply with these requirements, Documneted Procedure means  that the procedure is established, Documented, Implimented and Maintained. 

The Documentation requirements can be covered in mpre 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 aove, the roganization may require some additional documents which may or may not be part of Quality Manual.

What is AS 9100? What is the History of Aerospace Quality Management System (QMS) Standards?

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 establish 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.

ISO 9001 and Certification

 

As said in an earlier article, ISO does not itself certify organizations or the certification bodies.

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 certification 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 Certification 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.

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 ISO 9001, 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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What is ISO

ISO (International Organization of Standardization) is the worlds largest developer and publisher of International Standards.
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.

What is Standard

If you go by the dictionary, the word 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 define the minimum requirements for a product to be called as a standard product. 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.

What is Quality?

I know i am opening the can of worms again on trying to define as what is quality. This discussion is as old as the term quality. We are still unable to define if this is  a noun or an adjective.
This is a term which has a variety of definitions. In fact if you ask 10 people in a group  and get ready for at least 15 unique answers.
If you look at the popular dictionaries you will find the following definitions
Oxford Dictionary : 1. the standard of something as measured against other things of a similar kind; the degree of excellence of something: 2. a distinctive attribute or characteristic possessed by someone or something:
Merriam-Webster's : 1. A peculiar and essential character 2. an inherent feature 3. A degree of excellence 4. A distinguishing attribute.
These definitions are not of help if you are looking as a quality professional.
Also the Gurus on this subject define it differently Now let us see what the Gurus on the subject matter say.
Anon  “Common sense set down on paper”
Joseph M. Juran: "Fitness for use." Fitness is defined by the customer.
"Quality" means those features of products which meet customer needs and thereby provide customer satisfaction”
"Quality" means freedom from deficiencies-freedom from errors”
Subir Chowdhury: "Quality combines people power and process power."
Philip B. Crosby: "Conformance to requirements."
Robert Pirsig: "The result of care."
Genichi Taguchi, with two definitions:

a. "Uniformity around a target value." The idea is to lower the standard deviation in outcomes, and to keep the range of outcomes to a certain number of standard deviations, with rare exceptions.

b. "The loss a product imposes on society after it is shipped." This definition of quality is based on a more comprehensive view of the production system.

Peter Drucker: "Quality in a product or service is not what the supplier puts in. It is what the customer gets out and is willing to pay for."
W. Edwards Deming: concentrating on "the efficient production of the quality that the market expects,"
Gerald M. Weinberg: "Value to some person".
let us see what other say on this
ISO 9000: "Degree to which a set of inherent characteristics fulfills requirements."
Six Sigma: "Number of defects per million opportunities."
American Society for Quality: "A subjective term for which each person has his or her own definition. In technical usage, quality can have two meanings: a. The characteristics of a product or service that bear on its ability to satisfy stated or implied needs; b. A product or service free of deficiencies."
JAA (Joint Aviation Authorities – Currently EASA) : “The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs” 
Now let me attempt my own
“Quality can be defined as the best and continuous effort of an organization or individual, to prove their capabilities to meet the expectations of those who are interested in it”
I tried to cover many of the definitions above. The interested parties can be the Organization themselves, their customers, the regulators everybody is interested parties.
I covered the needs by using the word “to meet the expectations”. customer wants value for money, or safety organization expects Profits, less defects, no complaints etc. the regulators want compliance and conformance.