ISO/TS 16949 checklist about production and service provision
ISO/TS 16949 checklist about production and service provision
Clause 7.5
7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION
7.5.1 Does the organization plan and carry out production and service provision under the following controlled conditions, as applicable:
a) the availability of information that describes the characteristics of the product?
b) The availability of work instructions, as necessary?
c) The use of suitable equipment?
d) The availability and use of monitoring and measuring devices?
e) The implementation of monitoring and measurement?
f) The implementation of release, delivery and post delivery activities?
7.5.1.1 CONTROL PLAN
7.5.2 Does the organization:
- develop control plans at the system subsystem, component and/or material level, for the product supplied, including those for bulk materials produced by the organization and all purchased products and materials?
- Have a control plan for pre-launch and production that take into account the design FMEA and manufacturing process FMEA outputs?
7.5.3 Does the organization’s control plan:
- list the controls used for the manufacturing process control?
- Includes methods for monitoring and recording results of control exercised over special characteristics (see 7.3.2.3 of ISO/TS16949:2002) defined by both the customer and the organization?
- Include the customer required information if any?
- Initiate the specified reaction plan (See 8.2.3.1 of ISO/TS16949:2002) when the process becomes unstable or non capable?
7.5.4 Does the organization review and update control plans when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources or FMEA (see 7.1.4 of ISO/TS16949:2002)?
7.5.1.2 WORK INSTRUCTIONS
7.5.5 Has the organization prepared documented work instructions for all employees having responsibilities for the operation of processes?
7.5.6 Are the organization’s work instructions accessible for use at the workstation?
7.5.7 Are the organization’s work instructions derived from sources such as the quality plan, the control plan and the product realization process?
7.5.1.3 VERIFICATION OF JOB SET-UPS
7.5.8 Does the organization verify job set-ups whenever performed?
7.5.9 Are the organization’s work instructions available for set up personnel?
7.5.10 Does the organization use statistical methods of verification of job set-ups where applicable?
7.5.1.4 PREVENTIVE AND PREDICTIVE MAINTENANCE
7.5.11 Does the organization identify key process equipment and provide resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system?
7.5.12 Does the organization’s preventive maintenance system minimally include the following:
- planned maintenance activities?
- Packaging and preservation of equipment, tooling and gauging?
- Availability of replacement parts for key manufacturing equipment?
- Documenting, evaluating and improving maintenance objectives?
7.5.13 Does the organization utilize predictive maintenance methods to continually improve the effectiveness of its preventive system?
7.5.14 Does the organization provide resources for tool and gage design, fabrication and verification activities?
7.5.15 Does the organization establish and implement a system for tooling management including:
- maintenance and repair facilities and personnel?
- Storage and recovery?
- Set up?
- Tool change programs for perishable tools?
- Tool design modification documentation, including engineering change level?
- Tool modification and revision to documentation?
- Tooling identification defining the status?
7.5.16 Has the organization implemented a system to monitor its tooling management activities if any work is outsourced?
7.5.1.6 PRODUCTION SCHEDULING
7.5.17 Is the organization’s production scheduled in order to meet customer requirements?
7.5.1.7 FEEDBACK OF INFORMATION FROM SERVICE
7.5.18 Has the organization established and maintained a process for communication of information on service concerns to manufacturing, engineering and design activities?
7.5.1.8 SERVICING AGREEMENT WITH CUSTOMER
7.5.19 When there is a servicing agreement with the customer, does the organization verify the effectiveness of:
- any organization service centers?
- Special purpose tools or measurement equipment?
- Training of servicing personnel?
7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION
7.5.20 Does the organization validate any processes for all its production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement?
7.5.21 Does the organization’s validation of processes for all its production and service provision demonstrate the ability of these processes to achieve planned results?
7.5.22 Has the organization established arrangements for all its processes for production and service provision including, as applicable:
a) defined criteria for review and approval of the processes?
b) Approval of equipment and qualification of personnel?
c) Use of specific methods and procedures?
d) Requirements for records?
e) Revalidation?
7.5.3 IDENTIFICATION AND TRACEABILITY
7.5.23 Does the organization identify the product by suitable means throughout product realization?
7.5.24 Does the organization identify the product status with respect to monitoring and measurement requirements?
7.5.25 Where traceability is a requirement, does the organization control and record the unique identification of the product (see 4.2.4 of ISO/TS16949:2002)?
7.5.4 CUSTOMER PROPERTY
7.5.26 Does the organization exercise care with customer properly while it is under the organization’s control or being used by the organization?
7.5.27 Does the organization identify, verify, protect and safeguard customer property provided for use or incorporation into the product?
7.5.28 Does the organization report to the customer and maintain records for customer property that is lost, damaged or otherwise found to be unsuitable for use?
7.5.4.1 CUSTOMER OWNED TOOLING
7.5.29 Are the customer owned tools, manufacturing, test, inspection tooling and equipment permanently marked so that the ownership of each item is visible, and can be determined?
7.5.5 PRESERVATION OF PRODUCT
7.5.30 Does the organization preserve the conformity of product during internal processing and delivery to the intended destination?
7.5.31 Does the organization’s preservation of product include identification, handling, packaging, storage and protection.
7.5.32 Does the organization’s preservation of production apply to the constituent parts of a product?
7.5.5.1 STORAGE AND INVENTORY
7.5.33 Does the organization assess the condition of product in stock at appropriate planned intervals to detect deterioration?
7.5.34 Does the organization use an inventory management system to optimize inventory turns over time and assure stock rotation?
7.5.35 Does the organization control obsolete product in a similar manner to nonconforming product?
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