3 Process approach

• 3.1 Types of processes
• 3.2 Process mapping
• 3.3 Process approach

3.1 Types of processes

Types of processes, components

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

The word processactivities that 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 that transform inputs into outputs (see also ISO 9000, 3.4.1) transforms inputs into outputs, creating added value and potential nuisances. 

A processactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) has three basic elements: inputs, activitiesset of tasks to obtain a deliverable and outputs. 

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

• title and type
• purpose (why?)
• beneficiary (for whom?)
• scope and activities
• initiators
• documents and records
• inputs
• outputs (intentional and not intentional)
• constraints
• occupational health and safety environment
• 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 that transform inputs into outputs (see also ISO 9000, 3.4.1) reviewa survey of a file, product, process so as to verify whether preset objectives are achieved (see also ISO 9000, 3.11.2) is conducted periodically by the processactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) owner (cf. annex 02). 

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

Figure 3-1. Components of a process

• which materials, which documents, which toolings? (inputs)
• which title, what objective, which activities, requirements, constraints? (process)
• which products, which documents? (outputs)
• how, which inspections? (methods)
• what is the level of performance? (indicators)
• who, with which competences? (people)
• with what, which machines, which equipment? (material resources)

Figure 3-2. Some elements of a process

Often the output of a processactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) is the input of the next processactivities that transform inputs into outputs (see also ISO 9000, 3.4.1).

You can find some examples of processactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) sheets in the documentany support allowing the treatment of information (see also ISO 9000, 3.8.5) pack D 02 and a list of processes in annex 03. 

Any organization (company) can be considered as a macro processactivities that 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, 3.2.4)   needs and expectations) and its outputs (products/services to meet customeranyone who receives a product (see also ISO 9000, 3.2.4)   requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4)).

Our preference is to identify a processactivities that 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 that 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 that transform inputs into outputs (see also ISO 9000, 3.4.1).

The processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) are (as we shall see in the following paragraphs) of management, realization and support types. Do not attach too much importance to processactivities that 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 that transform inputs into outputs (see also ISO 9000, 3.4.1).

3.1.1 Management processes

Management processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) are also known as piloting, decision, key or major processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1). They are part in the overall organizationand include elaboration of the policy, deployment of the objectivesmeasurable goal to be achieved and all needed checks. They are the glue of all the realization and support processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1).

The following processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) can be part of this family, cf. annex 03: 

• manage complaints
• address risks
• improve
• conduct an audit
• communicate
• establish process ownership
• develop strategy
• establish policy
• deploy objectives
• conduct management review

3.1.2 Realization processes

The realization (operational) processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) 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 stakeholderperson, group or organization that can affect or be affected by a company (see also ISO 26000, 2.20) satisfaction. 

They are mainly:

• manage patient rights
• manage reagents and consumables
• manage suppliers
• collect samples
• transport samples
• receive samples
• secure samples
• validate examination methods
• control internal quality
• compare performance
• validate result reports
• store samples
• manage business continuity
• control nonconformities
• implement corrective actions
• govern POCTs

3.1.3 Support processes

The support processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) provide the resources necessary for the proper functioning of all other processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1). 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 processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) are often:

• manage personnel
• manage facilities
• manage equipment
• control data
• manage documentation
• provide training
• manage inspection means
• maintain accounts

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3.2 Process mapping

Process mapping, process house

Process mapping is not a drawing; it is a mirror of the organization. If the mirror is blurred, management is too

Par excellence processactivities that 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, 3.6.4) of the ISO 15189 standard but is always welcome. 

The three types of processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) and some interactions are shown in figure 3-3.
 

Figure 3-3. The process house

Mapping, among other things, allows you to:

• obtain a global vision of the company
• identify the beneficiaries (customers), flows and interactions
• define rules (simple) for communication between processes

To obtain a clearer picture, you can simplify by using a total of about 15 core processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1). A core processactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) can contain several sub-processes: for example, the processactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) "develop the management system (MS)" can involve: 

• develop strategy
• establish policy
• address risks
• manage complaints
• conduct management review
• deploy objectives
• establish process ownership
• improve
• audit

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3.3 Process approach

Process approach and improvement

Simple solutions for now, perfection for later

The fourth qualityaptitude to fulfill requirements (see also ISO 9000, 3.6.2) management principle is the "process approach" (cf. ISO 9000, 2.3.4). Some benefits include:

• gaining a comprehensive view of the organization through process mapping
• identifying and managing responsibilities and resources
• achieving effective organizational management based on process indicators
• managing risks that could impact objectives

The process approachmanagement by the processes to better satisfy customers, improve the effectiveness of all processes and increase global efficiency (see also ISO 9001, 03) contributes enormously to the efficient management of the organizationa structure that satisfies a need (see also ISO 9000, 3.2.1)   (cf. annex 04). 

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 9001, 03) is included during the development, implementation and continual improvementprocess allowing the improvement of the global performance of the organization (see also ISO 9000, 3.3.2) of an MBLmedical biology laboratory management systemset of processes allowing objectives to be achieved (see also ISO 9000, 3.5.3), it allows one to achieve objectivesmeasurable goal to be achieved that are related to stakeholderperson, group or organization that can affect or be affected by a company (see also ISO 26000, 2.20) satisfaction, as is shown in figure 3-4.

Figure 3-4. Model of an management system based on 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 9001, 03) (cf. annex 04): 

• emphasizes the importance of:
  • understanding and complying with patient requirements
  • prevention so to react to unwanted elements such as:
    • complaints
    • nonconformities
  • 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
  • improvement of processes

The process approachmanagement by the processes to better satisfy customers, improve the effectiveness of all processes and increase global efficiency (see also ISO 9001, 03) is not:

• 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)

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