A.2 Elements of the control plan
The supplier shall develop a control plan that includes, as a minimum, the following contents.
a) General data
- control plan number,
- issue date, and revision date, if any,
- customer information (see customer requirements),
- supplier name/site designation,
- part number(s),
- part name/description,
- engineering change level,
- phase covered (prototype, pre launch, production),
- key contact,
- part/process step number,
- process name/operation description.
b) Product control
- product related special characteristics,
- other characteristics for control (number, product or process),
- specification/tolerance.
c) Process control
- process parameters,
- process related special characteristics,
- machines, jigs, fixtures, tools for manufacturing.
d) Methods
- evaluation measurement technique,
- error proofing,
- sample size and frequency,
- control method.
e) Reaction plan and corrective actions
- reaction plan (include or reference),
- corrective action.
Tuesday, April 24, 2007
Annex A (normative) Control plan (A.1)
Annex A
(normative)
Control plan
A.1 Phases of the control plan
The control plan shall cover three distinct phases as appropriate.
a) Prototype: a description of the dimensional measurements, material and performance tests that will occur during building of the prototype. The supplier shall have a prototype control plan if required by the customer.
b) Pre launch: a description of the dimensional measurements, material and performance tests that occur after prototype and before full production. Pre launch is defined as a production phase in the process of product realization which may be required after prototype build.
c) Production: documentation of product/process characteristics, process controls, tests, and measurement systems that occur during mass production.
Each part shall have a control plan but, in many cases, family control plans may cover a number of similar parts produced using a common process. Control plans are an output of the quality plan.
(normative)
Control plan
A.1 Phases of the control plan
The control plan shall cover three distinct phases as appropriate.
a) Prototype: a description of the dimensional measurements, material and performance tests that will occur during building of the prototype. The supplier shall have a prototype control plan if required by the customer.
b) Pre launch: a description of the dimensional measurements, material and performance tests that occur after prototype and before full production. Pre launch is defined as a production phase in the process of product realization which may be required after prototype build.
c) Production: documentation of product/process characteristics, process controls, tests, and measurement systems that occur during mass production.
Each part shall have a control plan but, in many cases, family control plans may cover a number of similar parts produced using a common process. Control plans are an output of the quality plan.
Design responsible organization (3.1.3~3.1.13)
3.1.3
design responsible organization
organization with authority to establish a new, or change an existing product specification for product delivered to a customer
NOTE This responsibility includes testing and verification of design performance within the customer's specified application.
3.1.4
error proofing
use of product and manufacturing process design and development features to prevent manufacture of non conforming products
3.1.5
laboratory
test facility that may include chemical, metallurgical, dimensional, physical, electrical, reliability testing or test validation
3.1.6
laboratory scope
quality record containing the following:
• specific tests, evaluations and calibrations that a laboratory is qualified to perform,
• list of the equipment which it uses to perform the above,
• list of methods and standards to which it performs the above
3.1.7
manufacturing
refers to the processes making or fabricating production materials, or production or service parts, or assemblies, or heat treating, painting, plating or other finishing services.
3.1.8
outsourcing
process of acquiring product from outside the organization
3.1.9
predictive maintenance
activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes to prevent disruption of production
3.1.10
premium freight
charges incurred additional to contracted delivery
3.1.11
remote location
location that supports sites and at which non production processes occur
3.1.12
site
location at which value added production processes occur
NOTE 1 Includes distributors of parts manufactured by other companies.
NOTE 2 Does not include suppliers of indirect materials, products.
3.1.13
special characteristics
product characteristics or manufacturing process parameters subject to variation which may affect safety or compliance with regulations, fit, function, performance or subsequent processing of product
design responsible organization
organization with authority to establish a new, or change an existing product specification for product delivered to a customer
NOTE This responsibility includes testing and verification of design performance within the customer's specified application.
3.1.4
error proofing
use of product and manufacturing process design and development features to prevent manufacture of non conforming products
3.1.5
laboratory
test facility that may include chemical, metallurgical, dimensional, physical, electrical, reliability testing or test validation
3.1.6
laboratory scope
quality record containing the following:
• specific tests, evaluations and calibrations that a laboratory is qualified to perform,
• list of the equipment which it uses to perform the above,
• list of methods and standards to which it performs the above
3.1.7
manufacturing
refers to the processes making or fabricating production materials, or production or service parts, or assemblies, or heat treating, painting, plating or other finishing services.
3.1.8
outsourcing
process of acquiring product from outside the organization
3.1.9
predictive maintenance
activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes to prevent disruption of production
3.1.10
premium freight
charges incurred additional to contracted delivery
3.1.11
remote location
location that supports sites and at which non production processes occur
3.1.12
site
location at which value added production processes occur
NOTE 1 Includes distributors of parts manufactured by other companies.
NOTE 2 Does not include suppliers of indirect materials, products.
3.1.13
special characteristics
product characteristics or manufacturing process parameters subject to variation which may affect safety or compliance with regulations, fit, function, performance or subsequent processing of product
Terms and definitions (3~3.1.2)
3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:
Supplier organization customer
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
Throughout the text of this International Standard, wherever the term «product» occurs, it can also mean “service”.
3.1 Terms and definitions for the automotive industry
For the purposes of this Technical Specification, the terms and definitions given in ISO 9000 : 2000 and the
following apply. However where there are terms for which the wording of the definition differs in ISO 9000: 2000, the definitions given in this Technical Specification apply.
3.1.1
continual improvement
optimization of characteristics and parameters of a product or process at a target value
NOTE Continual improvement is only applicable where conformance has been established.
3.1.2
control plan
documented descriptions of the systems for controlling parts and processes to provide control of all characteristics important for quality and engineering requirements
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:
Supplier organization customer
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
Throughout the text of this International Standard, wherever the term «product» occurs, it can also mean “service”.
3.1 Terms and definitions for the automotive industry
For the purposes of this Technical Specification, the terms and definitions given in ISO 9000 : 2000 and the
following apply. However where there are terms for which the wording of the definition differs in ISO 9000: 2000, the definitions given in this Technical Specification apply.
3.1.1
continual improvement
optimization of characteristics and parameters of a product or process at a target value
NOTE Continual improvement is only applicable where conformance has been established.
3.1.2
control plan
documented descriptions of the systems for controlling parts and processes to provide control of all characteristics important for quality and engineering requirements
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