What is Quality?

We can all recognise Quality when we come across it, but it is not easy to define.

The definition of quality provided by the International Standards Organisation (ISO 9001:2015, para 3.6.2) is:
The degree to which a set of inherent characteristics of an object fulfils requirements.
Note 1: The term “quality” can be used with adjectives such as poor, good or excellent.
Note 2: “Inherent ” means the characteristics existing in the object.

This definition is not satisfactory, and it does not really to how the word Quality is used in ISO 9001, the international standard for quality management.

If a product fulfils requirements and has the appropriate characteristics it is a quality product.  If the absence of a characteristic means that the product does not fulfil requirements it is not a quality product.  It is not helpful to describe an object as poor quality or excellent quality.

For the purpose of quality management, Quality can be defined as
Conformance to requirements (Philip Crosby, Quality is Free),
and Fitness for purpose or use (Joseph Juran, Quality Handbook).

Note:
There are circumstances where a product which does not have all required characteristics can be used for its intended purpose.  The product is not described as poor quality, but rather it is a non-conforming product which is “accepted by concession” (see ISO 9000:2015 para 3.12.5 and ISO 9001:2015 para 8.7). 

Where am I?

If you are lost you have probably taken a wrong turning a few minutes ago, and your best option is to re-trace your steps until you know where you are.

White rabbit disappearing down holeIf it is not practical to re-trace your steps you should look around for clues to tell you where you are.  When Alice followed the white rabbit and fell down the rabbit hole she thought she might surface in Australia or New Zealand, it might be written up somewhere – Lewis Carrol, Alice Through the Looking Glass

You could also ask someone but this may not help you if you do not understand the answer . . .
Read more

What is Benchmarking?

An Ordnance Survey benchmark is a recorded height above sea-level (based on the “zero” datum at Newlyn, in Cornwall).  The various types of marks are placed on buildings which are likely to survive so they can be used as reference locations for new construction.  The network has not been maintained.  Many of the buildings where benchmarks were located have been demolished.  In areas where there may be subsidence due to mining the values cannot be relied on.

The nearest benchmark to bradQual is on the former police station building (now QSS Tropical Fish) on Wakefield Road:
Old police station with OS benchmark
Location: 339 Wakefield Road (former police station)
Grid reference: SE 1751 3209, Waypoint: B21589
Height: 152.2202 m ODN (499 ft 4.92 in)

In the context of Quality Assurance the purpose of Benchmarking is to compare one’s business processes and performance metrics to best practices from other companies. Dimensions typically measured are quality, time and cost. In the process of best practice benchmarking, management identifies the best firms in their industry, or in another industry where similar processes exist, and compares the results and processes of those studied (the “targets”) to one’s own results and processes. In this way, they learn how well the targets perform and, more importantly, the business processes that explain why these firms are successful.

Is my Process In-Control?

Bell curveData often clusters around a central value with no bias to left or right.  Frequency of occurrence of any value is greatest at the centre, and it decreases as you move further away, the curve forms a bell shape.  Height or blood pressure of people in a population, and size of items produced by a machine, vary according to this Normal distribution.  By measuring a suitable sample and determining the mean or average value “μ” (the greek letter mu) and the standard deviationσ” (the greek letter sigma) it is possible to determine whether an individual item is within the expected limits.

normal distributionIf a population follows the Normal distribution
68.2% will be within +/- σ
95.4% will be within +/- 2σ

99.7% will be within +/- 3σ
(Only 3 items per thousand will fall outside the +/- 3σ limit.)

A manufacture takes samples from production, measures them and calculates average “μ” and standard deviation “σ“, to determine process capability.  If 3 standard deviations on either side of the average value exceeds the upper and lower limits for the product (even if no units measured were found to be unacceptable) the process does not meet requirements.

When a manufacturer is developing its production process it must ensure the average and the +/- limits are well within product requirements.  This will allow them to adjust the process to keep costs to a minimum and ensure the product remains within limits, to make the product Right First Time and avoid defects.  6 Sigma (see also next FAQ) has become a slogan for the application of these techniques.

What is 6 Sigma

6σ (six sigma) applies a set of empirical and statistical quality management methods to improve the processes, and the quality of output by identifying and removing the causes of defects and minimizing variability.

The process was originally developed at Motorola in 1986, they set a goal of “six sigma” for all manufacturing operations and this became a by-word for the management and engineering practices used to achieve it.  The name “six sigma” comes from the Normal distribution curve which is used to determine the spread of variables in a population.  Samples from the output of the process are measured, the average value “μ” (the greek letter mu) and the standard deviationσ” (the greek letter sigma) are determined.  6 standard deviations “σ” on either side of the average “μ” encompasses 99.99966% of the output.  If the upper and lower acceptance levels are outside of +/- limits there will be less than 3.4 defects per million opportunities (DPMO).

The application of is not limited to areas of the business where the variace can be described by a Normal distribution curve.  The goal is to improve all processes, not necessarily to the 3.4 DPMO level.  An organization must determine the appropriate performance level for each of their most important processes, strive to achieve them and to make improvements to reduce defects to zero. 

A key feature of is the “professionalizing” of quality management functions.  Formal programs adopt an elite ranking terminology (similar to some martial arts) to define a hierarchy (and career paths for practitioners).

identifies the following roles for its successful implementation:

  • Executive Leadership includes the CEO and other members of top management.  They are responsible for setting up a vision for implementation.
  • Champions take responsibility for implementation across the organization in an integrated manner.
  • Master Black Belts act as in-house coaches on . They devote 100% of their time to .  Apart from statistical tasks, they spend their time ensuring consistent application of across various functions and departments.
  • Black Belts operate under Master Black Belts to apply methodology to specific projects.
  • Green Belts are the employees who take up implementation along with their other job responsibilities, operating under the guidance of Black Belts.

Special training is needed for all of these practitioners to ensure that they follow the methodology and use the data-driven approach correctly.  There are various organisations in the UK offering classroom based and on-line  training, for further information contact Process Management International (PMI).

What is the CE Mark

CE mark showing proportions of CE marking is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985.  It is the manufacturer’s declaration that the product meets the requirements of the applicable EC directives.

The mark consists of the CE logo (as shown) and, if applicable, the four digit identification number of the Notified Body involved in the conformity assessment procedure.

CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. Such products fall under one or more Directives which determine the specific requirements that the product must meet in order to be CE marked. The list of product categories (and relevant EC directives) is shown below:

  • appliances burning gaseous fuels (2009/142/EC)
  • cableway installations designed to carry persons (2000/9/EC)
  • electrical and electronic equipment (2014/30/EU)
  • energy related products (2009/125/EC)
  • equipment and protective systems intended for use in potentially explosive atmospheres (99/92/EC)
  • explosives for civil uses, including pyrotechnics (2014/28/EU)
  • fabricated structural steelwork (EN 1090-1:2009)
  • household refrigerators and freezers (96/57/EC)
  • in vitro diagnostic medical devices (98/79/EC)
  • lifts (2014/33/EU)
  • low voltage machinery (2014/35/EU)
  • machinery (2006/42/EC)
  • measuring instruments (2014/32/EU)
  • medical devices (2007/47/EC)
  • non-automatic weighing instruments (2009/23/EC)
  • personal protective equipment (89/686/EEC)
  • pressure equipment (97/23/EC)
  • radio and telecommunications terminal equipment (1999/5/EC)
  • recreational craft (2003/44/EC)
  • toys (2009/48/EC)

Any organisation which supplies products to the european economic area must determine which directives are applicable and ensure they meet all applicable requirements.  Before a product can be put on the market Conformity Assessment must be conducted in accordance with approopriate requirements.

If a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and affixing the CE marking to their own product.  Products considered to have a greater risk have to be independently certified by a notified body. This is an organization that has been nominated by a Member State and has been notified by the European Commission. These notified bodies act as test labs and carry out the steps as listed in the directives mentioned above and then decided whether the product has passed. A manufacturer can choose its own notified body in any Member State of the European Union but should be independent of the manufacturer and a private sector organization or a government agency.

For further information on CE marking refer to the Blue Guide (2016) or follow the link to read the FAQ’s on CE Marking at the end of the Guide.

Pint glass with CE markThe various EU directives cover a wide range of products, it is not immediately obvious which directive is applicable.  Pint beer glasses are classed as measuring instruments, and they are CE marked in accordance with directive 2014/32/EU.  In this case the CE mark is applied by the manufacturer Festival Glass, Halifax and  “0846” is the reference number of the Notified Body, Bury Metropolitan Borough Council. (For a full list of Notified Bodies refer to the NANDO database.