3 Process approach T 22

 

3.1 Definitions

Terms and definitions

 3.1

The beginning of wisdom is the definition of terms. Socrates

Some definitions and acronyms:

Competence: personal skills, knowledge and experiences 
Conformity: fulfillment of a specified requirement 
Customer: anyone who receives a product 
Effectiveness: capacity to realize planned activities with minimum efforts
Efficiency: financial relationship between achieved results and used resources 
FMEA: failure mode and effects analysis
Indicator: value of a parameter, associated with an objective, allowing the objective measure of its effectiveness
Interested party: person, group or company affected by the impacts of an organization
Life-cycle: all phases in the life of a product, from design to disposal
Management system: set of processes allowing objectives to be achieved
Organization (company): a structure that satisfies a need
Performance: measurable and expected results of the management system
Process: activities that transform inputs into outputs
Product (or service): fevery result of a process or activity
QMS: quality management system
Quality: aptitude to fulfill requirements
Quality management: activities allowing the control of an organization with regard to quality
Quality management system: set of processes allowing the achievement of the quality objectives
Quality objective: related to quality, measurable goal that must be achieved 
Quality policy: statement by top management allowing the establishment of quality objectives
Requirement: explicit or implicit need or expectation
Risk: likelihood of occurrence of a threat or an opportunity  
Supplier: an entity that provides a product
System: set of interacting processes

Certain terms specific to the medical sector:

Advisory notice: notice on the use, modification, return or distribution of a medical device
Medical device: product or service to be used for purposes of diagnosis, prevention, monitoring, treatment, alleviation of disease or injury

A medical deviceproduct or service to be used for purposes of diagnosis, prevention, monitoring, treatment, alleviation of disease or injury (MD) is any object or service for medical purposes but it cannot be a drug or a biological productany outcome of a process or activity (see also ISO 9000, 3.4.2).

Examples of medical devicesproduct or service to be used for purposes of diagnosis, prevention, monitoring, treatment, alleviation of disease or injury: a syringe, a stethoscope, crutches, an insulin pump, dressings, a surgical robot.

In the terminology of integrated management systemsset of processes allowing objectives to be achieved (see also ISO 9000, 3.5.3), do not confuse:

Remark 1: the use of ISO 9000 and ISO 13485 definitions is recommended. The most important thing is to determine a common and unequivocal vocabulary for everyone in the company.

Remark 2: the customer can also be the user, the beneficiary, the trigger, the ordering party or the consumer.

Remark 3: documentation is any information that we must maintain (procedure ) or retain (record ).

For other definitions, comments, explanations and interpretations that you don’t find in this module and annex 06, you can consult: explications record

smileyMinute of relaxation. Game: Procedure

Books for further reading on quality and medical devices: explications

When I think of all the books still left for me to read, I am certain of further happiness. Jules Renard

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3.2 Process

Process types, management, realization and support processes

3.2 

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, activities and outputs. processus

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:

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

Inspection: the actions of measuring, testing and examining a process, product, service or material to establish whether requirements are met

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). record

The components of a processactivities that 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 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. record

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).

 

3.2.1 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 organization and include elaboration of the policy, deployment of the objectives 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:

 

3.2.2 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) and contribute directly to increase the added value. 

They are mainly:

 

3.2.3 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:

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3.3 Process mapping

Process mapping and house

mapping 

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 either ISO 13485 or ISO 9001 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:

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 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 QMS" can enter: processus

Two other processactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) examples ("design", figure 3-4 and "produce", figure 3-5) are: processus

design
Figure 3-4. Design process

produce
Figure 3-5. Produce process

Minute of relaxation. Game: Process

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3.4 Process approach

Process approach and improvement

3.4 

Simple solutions for now, perfection for later

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). record

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 maintenance of a QMSQuality Management System, it allows one to achieve objectives that are related to the effectivenesscapacity to perform planned activities with minimum effort (see also ISO 9000, 3.7.11)   of the QMSQuality Management System, as is shown in figure 3-6.

3-6
Figure 3-6. Model of an integrated management system based on process approach and maintenance of the effectiveness

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):

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:

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

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