What is the Quality of a Quality Management System


ISO 9000:2014 defines quality as the degree to which a set of inherent characteristics of an object fulfils requirements, where an object is anything perceivable or conceivable. The term object is added since the previous version the standard. According to this definition, the quality of a QMS is the degree to which a set of inherent characteristics of the QMS fulfills requirements. So, in the context of this blog, the QMS is the object. ISO 9001:2014 distinguishes the next characteristics of the object QMS:

  1. Accordance with or conformity to the international standard
  2. Adequacy
  3. Completeness
  4. Conformity to the organization’s requirements
  5. Effectiveness
  6. Integrity
  7. Scope
  8. Suitability

See table 1. In the list of characteristics, the term efficiency is not mentioned. I think that a QMS should, next to effective, also be efficient. The term efficiency is, however, more or less covered by the characteristics adequacy and suitability. Table 1 List of characteristics and required state of the QMS.

Characteristic Required state Section
Accordance with the ISO standard EstablishedImplemented Maintained Improved 4.4
Completeness 7.5.1
ConformityEffectiveness 9.1.3.c
Conformity to organization’s requirements and the international standard 9.1.3.a
Conformity to the international standard 5.3.a
Contribution to the effectiveness 7.3.c
Effectiveness 5.1.1.a
Effectiveness 5.1.1.i
Effectiveness Evaluated 9.1.1
Effectiveness ImplementedMaintained 9.1.3.b
Integrity Maintained 5.3.e
Integrity Considered 6.3.b
Scope 8.4.2
SuitabilityAdequacy Effectiveness Reviewed 9.3.1
SuitabilityAdequacy Effectiveness Improved 10.3

According to the Object-oriented Quality and Risk Management model (Van Nederpelt, 2012) each characteristic of an object should be defined. In ISO 9000:2014, not all characteristics of the QMS are defined. Only the term effectiveness is defined in ISO 9000:2014. It is defined as the extent to which planned activities are realized and planned results achieved. If we apply this definition to a QMS, than the effectiveness of a QMS is the extent which planned activities of the QMS are realized and planned results of the QMS are achieved. This definition makes sense. Some of the characteristics may be self-evident, such as conformity to the International Standard. Other characteristics, such as integrity, are less self-evident. The requirement of the QMS or the characteristics of the QMS are defined in ISO 9001:2014. The standard requires that the QMS or characteristics of the QMS ‘shall’ be in a specific state, such as established, implemented, maintained, improved, evaluated and reviewed. See also table 1. Conclusion is that the clarity of the standard could be enhanced by defining seven out of eight characteristics of the QMS. Moreover, adding requirements for the efficiency to the QMS would make the standard more complete. References

  • ISO/DIS 9000:2014 Draft. Quality management systems – Fundamentals and Vocabulary.
  • ISO/DIS 9001:2014 Draft. Quality management systems – Requirements.
  • Van Nederpelt, Peter W.M. (2012). Object-oriented Quality and Risk Management (OQRM). A practical and generic method to manage quality and risk. Alpen aan den Rijn/New York: MicroData.

 

What is Quality?


LinkedIn discussions

  1. http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=245504954&gid=3633&trk=eml-anet_dig-b_nd-pst_ttle-cn&ut=2IyDMISQsROBM1
  2. http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=235369622&gid=3661165&commentID=140211430&trk=view_disc&ut=2HqoAr7wNjOBM1
  3. http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=237641744&gid=63662&commentID=137085229&trk=view_disc&ut=0CRCeMz0FvOBM1
  4. http://www.linkedin.com/groups/Quality-vs-Excellence-2018535.S.89384519?view=&srchtype=discussedNews&gid=2018535&item=89384519&type=member&trk=eml-anet_dig-b_pd-ttl-cn&ut=381bohk6pMOBM1
  5. http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=112987930&gid=76560&commentID=87194387&trk=view_disc&ut=1JFX6I48dROBM1
  6. http://www.linkedin.com/groupItem?view=&gid=3633&type=member&item=275910620&commentID=166815163&report%2Esuccess=8ULbKyXO6NDvmoK7o030UNOYGZKrvdhBhypZ_w8EpQrrQI-BBjkmxwkEOwBjLE28YyDIxcyEO7_TA_giuRN#commentID_166815163
  7. http://www.linkedin.com/groupItem?view=&srchtype=discussedNews&gid=76560&item=5819753064948588545&type=member&trk=eml-anet_dig-b_pd-ttl-cn&fromEmail=&ut=0yuunHs_a0Zm01

Blogs

  1. http://leanblitz.net/2013/05/what-is-quality/?goback=%2Egde_3633_member_245504954
  2. http://www.aleanjourney.com/2012/02/how-do-you-define-quality.html
  3. http://asq.org/blog/2013/01/how-do-you-define-quality/
  4. http://blog.isocertsolutions.com/blog/bid/270329/Quality-Management-Just-What-Is-Quality?goback=%2Egde_63662_member_237641744
  5. http://lifehacker.com/5967550/how-does-one-define-quality
  6. http://qualityandinnovation.com/2013/01/20/what-is-quality-the-best-explanation-ever/

51 Objects in ISO 9001


I identified in ISO 9001 51 objects which should be exists or implemented in order to control customer satisfaction.

34 (66%) of these objects are processes/procedures.

In a few cases quality dimensions of these objects are explicitely mentioned: commitment (5.1), customer focus (5.2) competence, awareness (6.2.2), traceability (7.5.3) and continuity (8.5.1).

Some key words are: control (6), design and development (6), quality (3) and review (3).

Below you will find the list of objects in alpabetical order.

Object

Process

ISO 9001
Analysis of data

X

8.4
Control and monitoring and measuring equipment

X

7.6
Control of design and development changes

X

7.3.7
Control of documents

X

4.2.3
Control of nonconforming product

X

8.3
Control of production and service provision

X

7.5.1
Control of records

X

4.2.4
Corrective action

X

8.5.2
Customer – satisfaction

8.2.1
Customer communication

X

7.2.3
Customer property

X

7.5.4
Design and development inputs

X

7.3.2
Design and development outputs

X

7.3.3
Design and development planning

X

7.3.1
Design and development review

X

7.3.4
Design and development validation

X

7.3.6
Design and development verification

X

7.3.5
Determination of requirement related to the products

X

7.2.1
Documentation

4.2.1
Human resources – competence, awareness

6.2.2
Improvement – continuity

8.5.1
Infrastructure

6.3
Internal audit

X

8.2.2
Internal communication

5.5.3
Management – commitment

5.1
Management respresentative

5.5.2
Management review

X

5.6.1
Measurement, analyses and improvement

X

8.1
Monitoring and measurement of processes

X

8.2.3
Monitoring and measurement of product

X

8.2.4
Organisation – customer focus

5.2
Planning of product realization

X

7.1
Preservation of product

X

7.5.5
Preventive action

X

8.5.3
Product identification /product – traceability

X

7.5.3
Provision of resources

6.1
Purchasing information

X

7.4.2
Purchasing process

X

7.4.1
QMS

4.1
QMS planning

X

5.4.2
Quality manual

4.2.2
Quality objectives

5.4.1
Quality policy

5.3
Reponsabilities and authorities

5.5.1
Review input

X

5.6.2
Review of requirements related to the product

X

7.2.2
Review output

X

5.6.3
Training

6.2.2
Validation of processes for production and service provision

X

7.5.2
Verification of purchased products

X

7.4.3
Work environment

6.4
 

34

 

Is the Concept of Focus Areas Powerful?


A focus area is a simple concept. It is just a combination of something and one quality dimension (or characteristic) of that something.

Let us take SECURITY of a WEBSITE as an example of a focus area. The WEBSITE is something. SECURITY is a quality dimension of that something.

16 Reasons why the concept of focus areas is powerful

1) Scope. A focus area is something management can focus on. One can restrict the scope of management or assessment by focus areas.  You can choose to focus on one focus area such as SECURITY of the WEBSITE but you can choose to focus on 10 or 100 focus areas too.

2) Measures. It is easier to determine what measures or actions are necessary for a focus area. For example, possible measures to control the SECURITY of a WEBSITE are to implement a fire wall and an intrusion detection system.

3) Cause and effect relationships. Focus areas are related. The CONTINUITY of a COMPANY is dependent on the SECURITY of a WEBSITE. Therefore, focus areas can be used to express cause and effect relationships. Problems with focus area A can cause problems with focus area B. Cause and effect relationships are essential in risk management.

4) Objectives. Risk is defined as the effect of uncertainty of objectives (ISO 31000). Objectives can be expressed in terms of focus areas. CONTINUITY of the COMPANY,  SHAREHOLDER’S VALUE of a COMPANY or SATISFACTION of the CUSTOMER  are examples of objectives. Objectives can be formulated more precise by adding a requirement to that focus area.

5) Risk source. A risk source can be expressed in terms of focus areas. Problems with the SECURITY of a WEBSITE is an example of a risk source.

6) Quality. Quality is defined the degree to which a set of inherent characteristics fulfils requirements (ISO 9001). We can change this definition a little bit without changing the meaning of the definition:  Quality is the degree to which focus areas fulfils requirements. That makes focus areas relevant in the field of quality management. The quality of a WEBSITE is the degree to which the WEBSITE fullfils the requirements of SECURITY and other quality dimension of a website.

7) Requirements. It is possible to formulate requirements for each focus area. This makes is possible to check if we are in control of a focus area such as SECURITY of the WEBSITE. A requirement is according to ISO 9000: a need or expectation that is stated, generally implied or obligatory.

8) Responsibility. Management can make a manager or department responsible for a focus area. The IT-department is, for example, responsible for SECURITY of the WEBSITE. This responsibility can be distributed to specific staff within the IT-department.

9) Definition.  A focus area can be defined. The definition of SECURITY of a WEBSITE is, for example, the degree to which a website cannot be accessed by unauthorised people. A definition makes it easier  to know what you are managing precisely.

10) Indicators. For each focus areas one or more indicators could defined. However, an indicator should be relevant and effective.

11) Floating adjectives. Focus areas solve the problem of ‘floating adjective’. In management literature, adjectives are often mentioned without the associated objects. Adjectives like transparency, reliability and sustainability are notorious examples. We should ask ‘transparency of what?”.  And secondly, how is it defined? SECURITY is also often mentioned without the accompanying object which makes this term almost meaningless.

12) Identifications of focus areas. It is quite easy to identify and make a list of focus areas. Step 1 is to identify ‘objects’ inside and outside the organisation, e.g., WEBSITE, CUSTOMER and COMPANY. Step 2 is to associate quality dimensions or characteristics to these objects. Another approach is to read a few strategic documents and identify focus areas in these documents. This makes is possible to make a rather complete list of focus areas (long list) that is relevant for the organisation.

13) Integration of Quality and Risk Management. It is much easier to integrate quality and risk management if both disciplines use the concept of focus areas.

14) Customization. Focus areas make it possible to customize your quality and risk management system. Focus areas are the building blocks or backbone of your management system.

15) Frameworks. Focus areas can be used the develop frameworks.  The hierarchy of the framework is object (level 1), focus area (level 2) and requirement (level 3). It makes clear to which object of focus area a requirement applies. Focus areas adds structure to a framework and neatly arrange a framework.

16) Language of the board. Board members don’t like to talk about technical details. They like to talk in broad concepts like SATISFACTION of the CUSTOMER or SECURITY of the WEBSITE.

Background

The concept of focus area is one of the key concepts in the Object-oriented Quality and Risk Management (OQRM) model.  All information about this model can be found at http://www.oqrm.org/English.

Product Quality


The quality dimensions of a product are identified by Garvin (1984). He distinguishes the next eight dimensions.

  1. Performance of a product – The primary operating characteristics of a product.
  2. Features of a product – Secondary characteristics that supplement the product’s basic functioning.
  3. Reliability of a product– The probability of a product’s failing within a specific period of time.
  4. Conformance of a product – The degree to which a product’s design and operating characteristics match pre-established standards.
  5. Durability of a product – When repair is not possible: the amount of use one gets from a product before it physically deteriorates. When repair is possible: the amount of use one gets before it breaks down and replacement is regarded as preferable to continued repair.
  6. Serviceability of a product – The speed, courtesy, and competence of repair.
  7. Aesthetics of a product – The looks, feel, sound, taste and smell of a product.
  8. Perceived quality of a product – The reputation or image of a product.

Furthermore, Garvin categorizes these dimensions in three groups:

  1. Product-bases approach: performance, features and durability.
  2. Manufacturing-based approach: conformance, reliability.
  3. User-bases approach: aesthetics and perceived quality

There is – according to Garvin – a relationship between the quality of the product and

  1. The price of the product
  2. (Effectiveness of) advertising.
  3. Cost of the product
  4. Profitability of the company

I would like to add there is a strong relationship with customer satisfaction.

References

Garvin, David A. (1984). What Does “Product Quality” Really Mean? Sloan Management Review, Fall 1984.

Can We Integrate Quality and Risk Management?


Some people question if quality management and risk management can be integrated.

Firstly, let us look at ISO’s definition of quality and risk.

  • Quality is the degree to which a set of inherent characteristics fulfils requirements (ISO 9001).
  • Risk is effect of uncertainty on objectives (ISO 31000).

Secondly, let us take a car as an example.

  • A characteristic of a car is safety.
  • A requirement for the safely of a car is compliance with legal rules.
  • An objective is that the safety of car complies with legal rules.

As we can see there is not much difference between a requirement and an objective. We even could define an objective as a requirement for a specific characteristic.

Furthermore

  • Both in quality management and risk management actions should be taken to stay or get in control.
  • Both in quality management and risk management cause and effect analyses are used as techniques to determine which actions are necessary.
  • The concept of ‘uncertainty’ is relevant in quality management too.
  • Bad quality of object X is a risk for the quality of object Y.

In my view, it is possible and useful to integrate quality management and risk management. There are many similarities and they can be applied in the same domains too.

NB: In the pharmaceutical context, the term quality risk management is introduced in 2005 (ICH, 2005).

Popescu and Dascalu (2011) researched the integration of risk management into quality management.

Reference

ICH (2005). Harmonised tripartite guideline quality risk management. Current step 4, 9 November 2005. Website: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf

Popescu, Maria; Dascslu, Adina (2011). Considerations on Integrating Risk and Quality Management. Annals of “Dunarea de Jos” University of Galati. Years XVII-no 1/2011. Website: http://www.ann.ugal.ro/eco/Doc20011_1/PopescuM_DascaluM.pdf

Van Nederpelt, Peter (2012). Object-oriented quality and riks management. New York/Alphen aan den Rijn: Lulu Press/Microdata. Website: http://www.oqrm.org/English

Software quality


Software has a vast number of quality dimensions (40). These dimensions are layed down and defined in an ISO standard  (ISO 25010, 2011).

1.Functional suitabilityThe degree to which the product provides functions that meet stated and implied needs when the product is used under specified conditions

  • Suitability
  • Accuracy
  • Interoperability
  • Security
  • Compliance

2. ReliabilityThe degree to which a system or component performs specified functions under specified conditions for a specified period of time.

  • Maturity
  • Fault Tolerance
  • Recoverability
  • Compliance

3. OperabilityThe degree to which the product has attributes that enable it to be understood, learned, used and attractive to the user, when used under specified conditions

  • Appropriateness
  • Recognisability
  • Ease of use
  • Learnability
  • Attractiveness
  • Technical accessibility
  • Compliance

4. Performance efficiencyThe performance relative to the amount of resources used under stated conditions

  • Time Behaviour
  • Resource Utilisation
  • Compliance

5. SecurityThe degree of protection of information and data so that unauthorized persons or systems cannot read or modify them and authorized persons or systems are not denied access to them

  • Confidentiality
  • Integrity
  • Non-repudiation
  • Accountability
  • Authenticity
  • Compliance

6. CompatibilityThe degree to which two or more systems or components can exchange information and/or perform their required functions while sharing the same hardware or software environment

  • Replaceability
  • Co-existence
  • Interoperability
  • Compliance

7. MaintainabilityThe degree of effectiveness and efficiency with which the product can be modified

  • Modularity
  • Reusability
  • Analyzability
  • Changeability
  • Modification stability
  • Testability
  • Compliance

8. TransferabilityThe degree to which a system or component can be effectively and efficiently transferred from one hardware, software or other operational or usage environment to another

  • Portability
  • Adaptability
  • Installability
  • Compliance

Reference

ISO/IEC 25010:2011. Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — System and software quality models

Taxi driver’s quality


Hotel.com investigated the quality of taxi drivers. They distinguished seven characteristics and measured these characteristics worldwide. It is interesting to see what these characteristics are.

They said:

Safety is the biggest concern for travellers followed in order of importance by

  • value for money
  • knowledge of area
  • quality of driving
  • availability
  • cleanliness
  • friendliness

It is a pity that these characteristics are not defined. So, I wonder, for example, what is meant by safety. And, does cleanliness refer to the cab or the taxi driver?

We should distinguish the taxi driver from the cab and service of the taxi driver here.

Reference

Website: http://press.hotels.com/en-us/news-releases/taxi-hotels-com-reveals-best-cities-to-hail-a-taxi/

Data quality


image002Can data quality be approached in a another way? And, will this approach make sense in the domain of data quality management?

Wong et al. (1996) developed the Data Quality Hierarchy of 4 Categories and 16 Dimensions (Fisher et al., 2011). These categories and dimensions are:

Intrinsic: Accuracy, Believability, Objectivity, Reputation.

Contextual: Value-added, Relevancy, Timeliness, Completeness, Amount of data

Representational: Interpretability, Ease of understanding, Representational consistency, Conciseness of representation, Manipulability.

Accessibility: Access, Security.

All these dimensions are associated with the ‘object’ data. These categories and dimensions are chosen from a data consumer point of view.

However, data is a broad concept. This makes it hard to define all dimensions unambiguously which is recommendable if we want to manage data quality. We need to know what we want to manage.

Let us see if an object-oriented approach (Van Nederpelt, 2012a) could help us to get an another view on data quality. We will take, therefore, four steps:

Step 1: Split the object data in related objects. This step results in eleven objects:

  1. Data in a dataset. Related: values, content.
  2. Records in a dataset. Related: rows in a table, units.
  3. Variables in a dataset. Related: data items, fields, columns in a table.
  4. Cells in a dataset.
  5. Classification system used in the dataset. Related: code lists.
  6. Dataset as a whole. Related: file, table. A collection of records.
  7. Set of datasets. Related: database.
  8. Delivery of a dataset. This is the process of providing the dataset to the user.
  9. Concepts of a dataset. The concepts of a dataset consists of the meaning of the units in the dataset, the population of the dataset, the meaning of the variables in the dataset, the classification systems and the reference period. Related: definitions, conceptual meta data. Related: specifications.
  10. Description of the concepts of a dataset.
  11. Procedure to create a dataset.

Step 2: Associate Wong’s dimensions with one or more of these objects. The object-oriented model calls a combination of an object and one dimension a ‘focus area’. This concept is new in the field of quality management.

Step 3: Formulate a definition of each combination of an object and one dimension (focus area). Most of these definitions were found in Fisher et al. (2011) or were derived from Fisher’s definitions.

Step 4: Complete the dimensions (focus areas) if we miss some. These dimensions are marked with a “*”. We will, however, never be complete unless we will mention all 179 attributes found by Wong et al. (1996).

The result of these four steps is:

Accessibility

  • Accesibility of a dataset is the extent to which a dataset is available for users. In this context the term file will be more appropriate than dataset.

Accuracy

  • Accuracy of data in a dataset is the extent to which data in a dataset represent the real world. It is considered the most important characteristic of data.

Added-value

  • Added-value of  data in a dataset is the extent to which data in a dataset are beneficial and provide advantage from their use.

Amount

  • Amount of data in a dataset is the quantity of data in a dataset.
  • Amount of records in a dataset is the number of records in a dataset.
  • Amount of variables in a dataset is the number of variables in a dataset.

Believability

  • Believability of data in a dataset is the extent to which users believe data in a dataset are accurate.  Also: Structural believability.
  • Believability of a process that creates a dataset. Also: procedural believability. Many other attributes can be associated with a process that creates a dataset, such as efficiency, effectiveness, duration, complexity, robustness, need of capacity and costs.
  • Related: credibility.

Completeness

  • Completeness of data in a dataset is the extent to which cells of a dataset are not void.
  • Completeness of variables in a dataset is the extent to which variables in a dataset is complete. Also called structural completeness.
  • Completenesss of records in a dataset is the extent to which all records the user needs are in the dataset. Related: Coverage.
  • Completeness of the description of the concepts of a dataset is the extent to which all concepts of the dataset are described.

Conciseness of representation

  • Conciseness of representation of data in a dataset is the extent to which data in a dataset are brief and to the point. Related: Ease of understanding, clarity.

Consistency

  • Consistency of data in a dataset is the extent to which data meet specific rules. These rules can apply to data at different levels: one variable, between variables, between records, for the whole dataset en between datasets. These rules can also apply to transition of a value of a variable to another value. Related: integrity, validity.

Correctness

  • Correctness of the description of the concepts of the dataset *) is the extent to which the description of the concept of the dataset reflects the meaning of the data.

Ease of understanding

  • Ease of understanding of data in a dataset is the extent to which data in a dataset are clear, unambiguous and can be comprehended.
  • Ease of understanding of the description of the concepts of a dataset *) is the extent to which data the description of the concepts of a dataset is clear, unambiguous and can be comprehended. Related: clarity, readability.

Interpretability

  • Interpretability of the concepts of a dataset is the clarity of the concept of a dataset. The interpretability of the concept of the dataset is dependent on the quality of the description of the concepts of the dataset. Related: Ease of understanding, clarity.

Manipulability

  • Manipulability of data in a dataset is the extent to which data in a dataset can be modified, joined with other data, aggregated and customized.
  • Manipulablity of a dataset is the extent to which a dataset can be uploaded, downloaded and moved.

Objectivity

  • Objectivitiy of data in a dataset is the extent to which data are created by objective means.  There is a direct relationship between objectivity and believability. Objectivity enlarges believability.

Punctuality

  • Punctuality of the delivery of a dataset is the extent to which a dataset is delivered at the date and time as agreed with the user of the dataset.

Relevance

  • Relevance of data in a dataset is the extent to which the data in a dataset is appropriate and useful to a particular task. Data could be irrelevant  because they are not accurate enough or incomplete.
  • Relevance of variables in a dataset is the extent to which variables in a dataset are useful for the user. The dimension relevance can also be applied to one variable.
  • Relevance of records in a dataset is the extent to which the records in a dataset are useful.  A dataset might contain double records and/or superfluous records.
  • Relevance of the concepts of a dataset is the extent to which the concept of a dataset is appropriate and useful to a particular task.

Reputation

  • Reputation of a dataset is the opinion people have about a dataset and its data because of what has happened in the past. Related: believability, credibility.

Security

  • Security of data in a dataset is the extent to which data in a dataset is protect against unauthorized users.
  • Security of variables in a dataset is the extent to which specific variables are protected against unauthorized users.
  • Security of records in a dataset is the extent to which specific records are protected against unauthorized users.
  • Security of a dataset is the extent to which a dataset is protected against unauthorized users. Related: Confidentiality. Security and accessibility have an inverse relationship.

Timeliness

  • Timeliness fo the delivery of a dataset is the period between the end of the reference period and the moment of delivery of the dataset to the user.  Related: Age of the dataset.

Unambiguity

  • Unambiguity of the description of the concepts of a dataset *) is the extent to which the description of the concept of a dataset cannot be misinterpreted. There is an inverse relationship between unambiguity and ease of understanding and clarity. Unambiguous text might not be easy to understand.

Discussion

The object-oriented approach results in one hand in a longer list of definitions. On the other hand, the dimensions in combination with an object (focus areas) have a more delineated scope. This enables us to communicate about data quality more precisely.

Not all dimensions are equality important for all purposes. Therefore, the user have to make a choice which dimension he want to focus on.

Next to data quality, the factors that influence data quality are important in order to manage data quality. Many factors are responsible for data quality. Van Nederpelt (2012b) identified 49 factors and described it in a paper.

References

Fisher, Craig; Lauria, Eitel; Chengalur-Smith, Shobha; Wang, Richard (2011). Introduction to Information Quality. Bloomington: AuthorHouse.

Longman (2010). Dictionary of Contempory English. Harlow, England: Pearson Eduction Limited.

Nederpelt, Peter W.M. van (2012a). Object-oriented Quality and Risk Management (OQRM). A practical and generic method to manage quality and risk. New York/Alphen aan den Rijn: Lulu Press/MicroData.

Nederpelt, Peter W.M. van (2012b). 49 Factors that Influence the Quality of Secondary Data Sources. The Hague/Heerlen: Statistics Netherlands.

Wong, R.Y.  and Strong, D. (1996). Beyond Accuracy: What data quality means to Data Consumers. Journal of Management Information Systems, 1996. 12(4): p. 5 – 34.

More information about OQRM is collected at http://www.oqrm.org/English.

ISO 9000’s definition of requirement


ISO 9000 defines requirement as “need or expectation that is stated, generally implied or obligatory”. It seems that this definition causes some confusion because we have our own connotation with the word requirements and ISO does not follow our connotation.

image002I think we should distinguish three categories of ‘requirements’:

 Category A: Legal requirements.  Take as an example safety requirements (LinkedIn, 2013). Another example may be that a car must have white front lights (not red).  The source of these requirements is government.

 Category B: Needs and expectations. The source of these ‘requirements’ is the customer. These needs and expectations can be stated or implied. Sometimes, customers even don’t know their needs. Needs can even be subconscious. Needs and expectations can be unrealistic, out of scope of the suppliers product” (LinkedIn, 2013). Customers might be interested in the maximum speed of a car but less in the number of cylinders in the motor.  So, needs are in general not always technical or detailed.

Category C: Requirements as specified by the supplier (specified requirements or specifications). It needs no explanations that there should be some connection between specified requirements and category A and B. If not, the supplier will not sell its product. As Rob in LinkedIn (2013) stated so clearly “We have to meet with the customer and extract these expectations and redefine them in the set of requirements”.  It determines the success of the supplier in the market. Moreover, the supplier needs these requirements in order to be able to produce its product.

In case of a cruise ship, the customer and supplier will spend much time to discuss these requirements. In case of a bag of chips, the supplier might assume what the customer needs or expect or does an analyses with some representatives of the consumer market.

However, needs and expectation of the customer will not always be covered by the requirements as specified by the supplier. In a lot of cases, this will not be possible.

We connote easily the word requirement with requirements as specified by the supplier (category C).  This is confusing, because the definition of a requirement according to ISO 9000 is category A and B together and not category C.

May be this problem can be solved if ISO formulate quality not as the degree to which a set of characteristics fulfils requirements but as:

Quality is the degree to which a set of characteristics fulfils legal (obligatory) requirements as well as stated and generally implied needs and expectation of the customer.

Reference

LinkedIn (2013). Discussion in LinkedIn about ISO’s definition of quality. Website: http://www.linkedin.com/groupItem?view=&gid=3633&type=member&item=214312847&commentID=121954599&report%2Esuccess=8ULbKyXO6NDvmoK7o030UNOYGZKrvdhBhypZ_w8EpQrrQI-BBjkmxwkEOwBjLE28YyDIxcyEO7_TA_giuRN#commentID_121954599