Process Control
Process Control
Process Control
(title)
15/02/2020 (print date) 1/5 (page x of y) 001 (revision)
Process control
1. Subject
1.1 Purpose
1.2 Scope
1.3 Glossary
2. Responsibility
3. Documents
3.1 Procedures
3.2 Instructions and records
5. Development
History
1. Subject
1.1 Purpose
The purpose of this procedure is to present the different actions of process control.
1.2 Scope
This procedure applies to all processes in our organization. The relevant internal and
external issues of the QMS and actions to address the risks identified and improvements
opportunities found are taken into account.
1.3 Glossary
2. Responsibility
The production manager has the authority to write and update this procedure. He is
responsible for its implementation. The project manager is responsible for the
industrialization of new products and processes used. Each process owner must respect
the aspects of this procedure. The authority to decide on the frequency of process reviews
is up to each owner.
3. Documents
3.1 Procedures
Changes
Operational control
Risks
Design and development
External providers
§ 4.4.1 Establish, implement, maintain and continually improve the processes needed and
their interactions.
§ 4.4.2 Maintain and retain documented information necessary for the operation of the
processes and have confidence that they are carried out as planned.
§ 7.1.3 Infrastructure
§ 8.3.1 General
§ 8.4.1 General
5. Development
The processes in our organization (cf. Process list) are classified into three types:
management
realization
support
Each process is identified by its title (with verb to show the purpose), its owner, its inputs,
its outputs, its documented information, its resources, its constraints, its objectives and
indicators, its links with other processes, its risks and opportunities for improvement. More
details in the Risk procedure.
The mapping of our business processes enables us to obtain a global vision, identify
process customers, flows and interactions.
Each process owner is responsible for the performance of his process and outcomes. He is
also responsible for the availability of spare parts and anything provided by external
providers.
From the quality policy of our organization quality objectives are defined. The performance
of each process is monitored using key indicators, see the Process sheet. When a process
is externally provided its conformity is monitored. More details in the External providers
procedure.
Each owner regularly brings together the actors of the process (see Process review report)
to make a point about the situation, evaluate whether new risks have appeared, discuss the
latest ideas and find improvement opportunities. More details in the Operational control
procedure.
The performance criteria are determined by the process owner, the quality manager and
the actors of the process on the basis of the analysis of:
• customer specifications
• customer expectations
• internal constraints of production (production capacity and existing technological
equipment)
• results of FMEA studies
• results of statistical studies of similar processes
• specific quality requirements (control plan)
The control plan defines the elements applicable to each operation and process step,
inspection means (monitoring and measurement) used for the product and the process,
methods and criteria, the actions to implement, cf. the Work instruction.
Before the introduction of a new process a capability study is conducted over a period of
one to three weeks of production. More details in the Design and development procedure.
Any new process is subject to a qualification audit. This audit verifies that all QMS
requirements are met, the process is stable and the indicators of the quality objectives will
be achieved.
To ensure stable processes and conforming products staff have at workstations adequate
documented information, such as work instructions, instructions and procedures. This
documented information is displayed on each workstation appropriately.
Any change follows strict rules to ensure process performance in all circumstances. More
details in Changes procedure.
A special process is one for which the resulting output cannot be verified by traditional
means of inspection. This is the case when we have to perform destructive testing or when
the inspection cannot be performed until after delivery.
The "Guarantee product safety" process describes the provisions related to the safety of
the product during manufacture.