3 Process approach

 

3.1 Types

Types, components, elements, management, realization, support

 3.2

If you cannot describe what you are doing as a process, you do not know what you're doing. Edwards Deming

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. processus

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:

A processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) is, among other things, determined by its:

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 02). record

The components of a processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) are shown in figure 3-1: processus

process components
Figure 3-1. Components of a process

Figure 3-2 shows an example that helps to answer some questions:

process
Figure 3-2. 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 processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) sheets in the document pack D 02. record

Any organization (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 meet 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 documented information 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 shall 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's 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).

 

3.2.1 Management processes

Management processes are also known as piloting, decision, key or major processes. They are part in the overall organizationand include elaboration of the policy, deployment of the objectives and all needed checks. They are the glue of all the realization and support processes.

The following processes can be part of this family:

 

3.2.2 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 tdirectly to customer satisfaction. 

They are mainly:

 

3.2.3 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:

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3.2 Process mapping

Process house, core processes

mapping 

Par excellence processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) "mapping" is a multidisciplinary work. This is not a formal requirementexplicit or implicit need or expectation (see also ISO 9000, 3.1.2) of ISO 14971 but is always welcome. 

The three types of processes and some interactions are shown in figure 3-3 and D 02. record

house
Figure 3-3. Process house

The mapping, among other things, lets you:

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 MS" can enter: processus

Minute of relaxation. Game: Process

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3.3 Process approach

Process approach, Deming cycle

3.4 

Simple solutions for now, perfection for later

The fourth principle of quality management is “Process approach” (see ISO 9000, 2.3.4). Some benefits:

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 improvement of a management system, 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 3-4 (cf. ISO 9001, 0.2).

3-4
Figure 3-6. Model of an MS 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 08):

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 not:

The PDCA cycle, also called the Deming cycle, applies to the control of any processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1), including the integration of risk management into the framework of the company. The PDCA cycles (Plan, Do, Check, Act) 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 3-5).

pdca

Figure 3-5. The Deming cycle for risk management

To learn more about the Deming cycle and its 14 points of management theory, you can consult the book “Out of the Crisis” W. Edwards Deming, Economica, 2002, first published in 1982.

smileyMinute of relaxation. Paganini's violin concert performed with facial expressions.

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