1 Quality approach
1.1 History
The word quality, quality department history
1.1.1 The word quality
Quality comes from the Latin word qualitas, "way of being", itself derived from the adjective qualis, "as it is".
There are many definitions of the word quality. Some examples:
- state, disposition - Aristotle
- property, attribute - René Descartes
- compliance with requirements - Philip Crosby
- anything that can be improved - Masaaki Imai
- fitness for use - Joseph Juran
- ability to satisfy the customer - Kaoru Ishikawa
- degree to which a set of inherent characteristics of an object fulfils requirements, ISO 9000: 2005, § 3.6.2 (in other words: the ability of a product or service to meet needs)
- absence of defects - Joseph Juran
- seeking the satisfaction of all parties involved in a transaction - Yvon Mougin
- level of excellence
- take pride in your work (work well done)
- do it right the first time and all the time
- it is when the customer likes the product and the employee likes to make the product
- it's when the customer comes back and not the product
The Petit Robert alone gives us six different meanings for the word quality.
Our choice:
Quality: aptitude to fulfill requirements
Everyone makes quality, like Monsieur Jourdain made prose.
Everyone has a point of view on quality, often personal and interesting.
No one is against quality and in principle everyone accepts that:
Quality is a journey, not a destination
1.1.2 The quality department
In the code of King Hammurabi of Babylon (1730 BC), we find one of the oldest written traces of quality requirements:
- if an architect builds a house and one of the walls falls, this architect will consolidate this wall at his own expense
- if an architect builds a house and the house collapses and the master of the house is killed, that architect is liable to death
For centuries, quality was intrinsic to all craftsmanship (facilitated by direct contact with the customeranyone who receives a product (see also ISO 9000, 3.3.5)).
With the advent of industrialization (mass production) appeared the division of labor (design, production and inspection) and the interchangeability of parts (beginning of standardization).
In 1924, for the first time, a "quality assurance" department was created in the Bell Telephone company to better satisfy the end customeranyone who receives a product (see also ISO 9000, 3.3.5). At that time in this company, people who would become world-renowned thought leaders such as Shewhart, Deming and Juran worked on and developed the “statistical quality control” approach.
In the 1930s, excesses were reached. For example, in the same Bell Telephone company, it was noticed at one point that the inspection staff was more numerous than the workers!
Until the early 1940s, the inspection department (often called control) had the mission of verifying the conformity of finished productsany outcome of a process or activity (see also ISO 9000, 3.4.2). It was expensive (lots of checks) and not very efficient (defects were discovered at the end of the production cycle).
During the Second World War it was realized that poor quality could be very expensive – a direct link to human lives. Use of inspection at all stages of production began and certain requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.1.2) became mandatory (including reception). A finished production with a lot fewer defects was obtained (they were discovered quite early).
The first American military standards for inspection by sampling were put in place.
In 1949, the American Society for Quality Control (ASQC) was created.
The 1960s and 1970s saw the appearance of quality department, continual improvementpermanent process allowing the improvement of the global performance of the organization (see also ISO 9000, 3.2.13 and ISO 14 001, 3.2), prevention, the daily use of statistics in production, the involvement of all personnel and team spirit for quality. Many approaches and various tools emerged (see Chapters 9 and 10 of this module).
The first international standards related to quality (ISO 9000 family) appeared in 1987. We talk about quality assurance, zero defects, prevention, corrective and preventive actions, supplier quality assurance (SQA).
During the 1980s, the quality system encompassed all departments, all activities and all personnel.
To stand out, you have to surprise (pleasantly) the consumer with additional services, innovative and unexpected characteristics.
Since the 2000 version of the ISO 9001 standard, quality assurance has been replaced by quality management, the structure has been simplified, the mandatory procedures have reduced. Customer satisfactiontop priority objective of every quality management system (see also ISO 9000, 3.1.4), the process approachmanagement by the processes to better satisfy customers, improve the effectiveness of all processes and increase global efficiency (see also ISO 9004, Annexe B.5), efficiency and continual improvementpermanent process allowing the improvement of the global performance of the organization (see also ISO 9000, 3.2.13 and ISO 14 001, 3.2) have become priorities. Service activities have been added to (classical) industrial production.
Slowly but surely the quality department is transforming itself from a compliance expertise department into a cross-functional support department. The control of processes and the effectiveness of the management system are beginning to include new expectations related to efficiency, innovation and sustainable development. We talk less about quality but more about performance and excellence. Some stages in the history of the quality department are shown in figure 1-1.
Figure 1-1. History of the quality department
1.2 Principles
1.2.1 Management principles
The quality approach is a state of mind that starts with top management as a priority strategic decision and extends to all staff. Top management defines the quality policy, in which the quality objectives are set and applicable to all activities. The tool used to achieve the objectives is the quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.2.3). The concept of prevention is generalized.
The purpose of a management system (MS) is to increase customer satisfactiontop priority objective of every quality management system (see also ISO 9000, 3.1.4) (external and internal) by meeting their needs and expectations by continually improving processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) efficiency.
Quality costs almost nothing when customers are satisfied: they remain loyal to us. It is only when the customeranyone who receives a product (see also ISO 9000, 3.3.5) is not completely satisfied that quality becomes very expensive for us: sooner or later the customeranyone who receives a product (see also ISO 9000, 3.3.5) goes to a competitor.
Quality remains long after the price has been forgotten
The seven principles of quality management (see figure 1-2) will help us achieve sustainable performance (see ISO 9001: 2015, § 0.2):
Figure 1-2. The cost iceberg
1.2.2 PDCA cycle
The PDCA cycle, also called Deming cycle, applies to the control of any processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1). PDCA (Plan, Do, Check, Act) cycles are a universal basis for continual improvementpermanent process allowing the improvement of the global performance of the organization (see also ISO 9000, 3.2.13 and ISO 14 001, 3.2) (see figure 1-3).
- Plan – define and establish strategy, customers, policy, resources, objectives, documentation, products, processes, training, deadlines
- Do – organize, implement processes, indicators, produce the product
- Check – compare, inspect, analyze data, verify if objectives are met, validate, audit, learn
- Act – improve, react with actions and find new improvements (new PDCA)
1.3 Process approach
Process types, management, realization, support processes, process mapping, process approach
If you cannot describe what you are doing as a process, you do not know what you're doing. Edwards Deming
1.3.1 Process types
The word processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) comes from the Latin root procedere = go, development, progress (Pro = forward, cedere = go). Each processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) transforms inputs into outputs, creating added value and potential nuisances.
A processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) has three basic elements: inputs, activities and outputs.
A processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) can be very complex (launch a rocket) or relatively simple (audit a productany outcome of a process or activity (see also ISO 9000, 3.4.2)). A processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) is:
- repeatable
- foreseeable
- measurable
- definable
- dependent on its context
- responsible for its external providers
A processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) is, among other things, determined by its:
- title and its type
- purpose (why?)
- beneficiary (for whom?)
- scope and activities
- initiators
- documents and records
- inputs
- outputs (intentional and unintentional)
- restrains
- people
- material resources
- objectives and indicators
- person in charge (owner) and actors (participants)
- means of inspection (monitoring, measurement)
- mapping
- interaction with other processes
- risks and potential deviations
- opportunities for continual improvement
A processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) review is carried out periodically by the processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) owner (cf. annex 01).
The components of a processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) are shown in figure 1-4:
Figure 1-4. Components of a process
Figure 1-5 shows an example that helps answer the questions:
- which materials, which documents, which tooling? (inputs)
- which title, which activities, requirements, constraints? (process)
- which products, which documents? (outputs)
- how, which inspections? (methods)
- what is the level of performance? (indicators)
- who, with what competence? (staff)
- with what, which machines, which equipment? (material resources)
Figure 1-5. Some elements of a process
Often the output of a processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) is the input of the next processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1).
You can find some examples of process forms in the document pack D 02 and annex 02.
Any organizationa structure that satisfies a need (see also ISO 9000, 3.3.1) (company) can be considered as a macro processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1), with its purpose, its inputs (customeranyone who receives a product (see also ISO 9000, 3.3.5) needs and expectations) and its outputs (products/services to satisfy customeranyone who receives a product (see also ISO 9000, 3.3.5) requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.1.2)).
Our preference is to identify a processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) using a verb (buy, produce, sell) instead of a noun (purchases, production, sales) to differentiate the processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) from the company’s department or procedure to maintain and recall the purpose of the processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1).
The processes are (as we will see in the following paragraphs) of management, realization and support types. Do not attach too much importance to processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) categorizing (sometimes it is very relative) but ensure that all the company’s activities at least fall into one processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1)
1.3.1.1 Management processes
Management processes are also known as piloting, decision, key or major processes. They take part in the overall organization and include development of the policy, deployment of the objectives and all needed checks. They are the glue of all realization and support processes.
The following processes can be part of this family:
- develop strategy
- manage risks
- develop policy
- deploy quality objectives
- establish process ownership
- improve
- audit
- communicate
- plan the QMS
- acquire resources
- carry out management review
- measure customer satisfaction
- negotiate contract
- analyze data
1.3.1.2 Realization processes
The realization (operational) processes are related to the productany outcome of a process or activity (see also ISO 9000, 3.4.2), increase the added value and contribute directly to customer satisfactiontop priority objective of every quality management system (see also ISO 9000, 3.1.4).
They are mainly:
- design and develop new products
- purchase components
- produce products
- sell products
- inspect production
- maintain equipment
- implement traceability (identify and keep history)
- receive, store and deliver
- control nonconformities
- implement preventive and corrective actions
1.3.1.3 Support processes
The support processes provide the resources necessary for the proper functioning of all other processes. They are not directly related to a contribution of the productany outcome of a process or activity (see also ISO 9000, 3.4.2)'s added value but are still essential.
The support processes are often:
- control documentation
- provide information
- acquire and maintain infrastructure
- provide training
- manage inspection means
- manage staff
- keep accountability
1.3.2 Process mapping
Par excellence processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) “mapping” is a multidisciplinary work with the quality manager as the natural owner. This is not a formal requirementexplicit or implicit need or expectation (see also ISO 9000, 3.1.2) of the ISO 9001 standard but is always welcome.
The three types of processes and some interactions are shown in figure 1-6 and annex 02.
Figure 1-6. Process house
Mapping, among other things, allows you to:
- obtain a global vision of the company
- identify the beneficiaries (customers), flows and interactions
- define (simple) rules for communication between processes
To obtain a clearer picture, you can simplify by using a total of about 15 core processes. A core processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) can contain several sub-processes: for example, the processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) "develop the QMS" can involve:
- develop strategy
- manage risks
- develop policy
- plan the QMS
- deploy objectives
- acquire resources
- establish process ownership
- improve
1.3.3 Process approach
Simple solutions for now, perfection for later
The fourth principle of quality management is “Process approach” (see § 1.2.1). Some benefits:
- obtain a global vision of the company thanks to the mapping
- identify and manage responsibilities and resources
- achieve effective management of the company based on process indicators
- manage risks that could influence the objectives
Process approach: management by the processes to better satisfy customers, improve the effectiveness of all processes and increase global efficiency
When the process approachmanagement by the processes to better satisfy customers, improve the effectiveness of all processes and increase global efficiency (see also ISO 9004, Annexe B.5) is integrated during the development, implementation and continual improvementpermanent process allowing the improvement of the global performance of the organization (see also ISO 9000, 3.2.13 and ISO 14 001, 3.2) of a quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.2.3), it allows one to achieve objectives that are related to customer satisfactiontop priority objective of every quality management system (see also ISO 9000, 3.1.4), as is shown in figure 1-7 (cf. ISO 9001, 0.2).
Figure 1-7. Model of a QMS based on the process approach and continual improvement
The process approachmanagement by the processes to better satisfy customers, improve the effectiveness of all processes and increase global efficiency (see also ISO 9004, Annexe B.5) (cf. annex 03):
- emphasizes the importance of:
- understanding and complying with customer requirements
- prevention so as to react to unwanted elements such as:
- customer returns
- waste
- measuring process performance, effectiveness and efficiency
- permanently improving objectives based on pertinent measurements
- process added value
- relies on:
- methodical identification
- interactions
- the sequence and
- process management, which consists of:
- determining objectives and their indicators
- piloting related activities
- analyzing obtained results
- permanently undertaking improvements
- allows one to:
- better view inputs and outputs and their relationship
- clarify roles and responsibilities
- judiciously assign necessary resources
- break down barriers between departments
- decrease costs, delays and waste
- and ensures in the long run:
- control
- monitoring and
- continual improvement of processes
For a consulting, support or repair business identifying and defining processes and mapping may not be very useful. More important is to establish and describe for example:
- job descriptions
- staff competence
- the tools to use
- preferred methods for certain recurring cases
- crisis management ("You will not solve the problems by addressing the effects")
- blaming people (“Poor quality is the result of poor management" - Masaaki Imai)
- prioritizing investments (“Use your brain, not your money" - Taiichi Ohno)
Minute of relaxation. Cf. game: Process