[讨论]供应商审核
1 Is there a Quality function or well defined organization which provides customer advocate guidance to the total organization, and is this position fully supported by management? Is the organization’s quality documented system properly maintained and implemented?
Considerations:
a. The organization’s management with executive responsibility has appointed a management member from his/her organization with responsibility for implementation and maintenance of the quality system. Quality Management reports at the appropriate level within the organization to assure an effective quality system. The Quality System implementation and management includes all areas of ISO 9001:1994.
b. The Quality function performs final product acceptance audits and tracks internal defects as well as field hardware, software and service defects.
c. The organization has a documented new product release procedure with an escalation process and appropriate signature authority to stop the release if the product/service is not deemed ready for release.
d. A clear method exists for customers to communicate quickly with this group about quality issues. Example: 800 Hotline or other procedures.
e. Senior managers of the organization are advocates of quality improvement, e.g. Six Sigma process, Total Customer Satisfaction, 10X Cycle Time Reduction, and 5 Nines initiative as appropriate, and are supportive of the Quality function in its role to resolve internal defects and customer issues. The management supports the culture that quality is each individual’s overriding responsibility.
2 Does an internal assessment program exist as part of the quality system review process and does
Management regularly report on the results?
Considerations:
a. The organization can show evidence that a documented internal assessment program exists for the
quality system. Schedules are established for assessment of all areas of the quality systems.
b. The assessment frequency is sufficient to enable management to know that a business unit is in control.
c. Assessors are independent and have received sufficient training.
d. Assessment procedures are reviewed on a periodic basis to ensure they are effective.
e. Records and schedule pertaining to the internal assessment program are quality records and should be
collected , retained and dispositioned per quality record procedures.
3 Is management’s support of ongoing training (including problem solving, statistical technique, and quality training) sufficient and is it documented by an organizational training plan? Are employees adequately trained in statistical analysis, prevention, and problem solving methods in relation to the needs of the organization?
Considerations:
a. The organization has documented training plans for all employees, including management, new hire sand internally transferred personnel.
b. Training plans are written around business/quality objectives, they are reviewed regularly and updated as required.
c. Training plans are reviewed to ensure that employees are trained in mapping and other tools necessary for process improvement.
d. Training effectiveness is measured by management.
e. There is a specified, documented, and ongoing training program that includes a variety of tools and techniques, such as check lists, histograms, Pareto diagrams, cause and effect diagrams, scatter diagrams and control charts (SPC), stratified sampling, design of experiments (DOE), advanced problem solving techniques, team oriented problem solving, Taguchi methods/robust design concepts, design for manufacturability, process mapping, identification of critical characteristics, operational definitions, identification of responses/measurements/metrics, critical thinking skills, and 8D.
4 Do new product/process/technology/service development policies and procedures exist and do they
result in clearly defined project plans with appropriate metrics and approvals?
Considerations:
a. Policies and procedures exist which define minimum requirements appropriate resources and expectations for the development, introduction and manufacturing of new products, new/changed significant processes, technologies and services. These policies and procedures also define responsibility for implementation.
b. Qualified personnel who are adequately resourced are assigned to each project.
c. Existing policies and procedures assure that new products, technologies and services meet established performance goals, including cycle time goals and measurements, prior to introduction.
d. Policies and procedures require appropriate management visibility and approvals prior to committing new products, new/changed significant processes, technologies and services to production.
e. The organization complies with all provisions of their new product, new/changed significant processes, technology and service policies and procedures.
5 Is the capability of each operation, which controls critical-to-function characteristics for new products, fully qualified?
Considerations:
a. Cp’s and Cpk’s, or error rates of critical processes used to produce new products are fully quantified and qualified before production volumes are produced.
b. Statistical data is collected and used to control and improve these processes.
6 Are computer simulation and design tools used to the maximum extent practicable in the design of new products/technologies/services?
Considerations:
a. State of the art simulation models are used for the development of new products/services.
b. Tools, such as: Computer Aided Design (CAD), Computer Aided Manufacturing (CAM) and Simulation Modeling (S/M), are used to minimize development cycle time and improve quality.
7 Has a system been established with the supplier for identification and verification of corrective action?
Considerations:
a. The system includes the use of formal corrective action requests and enables follow-up on supplier’s corrective actions.
b. The system includes a method of preventing reoccurring defects.
c. The system includes verification of formalized methods of problem solving by suppliers
d. All records pertaining to supplier corrective actions are retained as quality records.
8 Is there an effective supplier certification program or equivalent supplier continuous quality improvement program?
Considerations:
a. There is a system for certifying suppliers.
b. There is a process which ensures continuous quality improvement of procured products and services and the rewarding of suppliers for their involvement in the programs
c. The system allows for customers to verify supplied product conformance to requirements either on site or at the supplier’s site when required by the purchasing documents.
d. Procedures are in place to identify, collect, file, store and dispose of all records pertaining to supplier certification.
9 Is the product or subassembly, and process to produce it routinely reviewed and are goals/plans established to continually improve at the required rate?
Considerations:
a. The organization regularly reviews performance of critical manufacturing metrics (quality, cycle time, on time delivery, product audit or reliability performance, equipment maintenance, SPC, process change management, and scrap) with management. Typical metrics are in Sigma, PPM, TDU, or DPU. b. Process goals are set using Quality Functional Deployment (QFD) or equivalent methodology.
b. Quality/Process improvement and cycle time reduction plans are in place. Product, subassembly, and process improvement results are in line with corporate/organizational improvement goals and customer requirements.
c. Quality metrics and management reviews records are maintained as Quality Records.
10 Does a system exists to assure that purchased materials, as received, conform to documented requirements prior to use?
Considerations:
a. There is a documented policy to assure conformance to requirements for purchased products. The policy may include such items as incoming inspection, supplier certification or other applicable methods.
b. Suppliers have documented procedures for verifying and recording product conformance to requirements prior to shipment, i.e., outgoing product inspections.
c. The system assures that purchased products conform to product design, manufacturing and other applicable requirements prior to use.
d. Any exceptions to the purchased conformance policies must be fully documented for subsequent trace ability if necessary.
Considerations:
a. The organization’s management with executive responsibility has appointed a management member from his/her organization with responsibility for implementation and maintenance of the quality system. Quality Management reports at the appropriate level within the organization to assure an effective quality system. The Quality System implementation and management includes all areas of ISO 9001:1994.
b. The Quality function performs final product acceptance audits and tracks internal defects as well as field hardware, software and service defects.
c. The organization has a documented new product release procedure with an escalation process and appropriate signature authority to stop the release if the product/service is not deemed ready for release.
d. A clear method exists for customers to communicate quickly with this group about quality issues. Example: 800 Hotline or other procedures.
e. Senior managers of the organization are advocates of quality improvement, e.g. Six Sigma process, Total Customer Satisfaction, 10X Cycle Time Reduction, and 5 Nines initiative as appropriate, and are supportive of the Quality function in its role to resolve internal defects and customer issues. The management supports the culture that quality is each individual’s overriding responsibility.
2 Does an internal assessment program exist as part of the quality system review process and does
Management regularly report on the results?
Considerations:
a. The organization can show evidence that a documented internal assessment program exists for the
quality system. Schedules are established for assessment of all areas of the quality systems.
b. The assessment frequency is sufficient to enable management to know that a business unit is in control.
c. Assessors are independent and have received sufficient training.
d. Assessment procedures are reviewed on a periodic basis to ensure they are effective.
e. Records and schedule pertaining to the internal assessment program are quality records and should be
collected , retained and dispositioned per quality record procedures.
3 Is management’s support of ongoing training (including problem solving, statistical technique, and quality training) sufficient and is it documented by an organizational training plan? Are employees adequately trained in statistical analysis, prevention, and problem solving methods in relation to the needs of the organization?
Considerations:
a. The organization has documented training plans for all employees, including management, new hire sand internally transferred personnel.
b. Training plans are written around business/quality objectives, they are reviewed regularly and updated as required.
c. Training plans are reviewed to ensure that employees are trained in mapping and other tools necessary for process improvement.
d. Training effectiveness is measured by management.
e. There is a specified, documented, and ongoing training program that includes a variety of tools and techniques, such as check lists, histograms, Pareto diagrams, cause and effect diagrams, scatter diagrams and control charts (SPC), stratified sampling, design of experiments (DOE), advanced problem solving techniques, team oriented problem solving, Taguchi methods/robust design concepts, design for manufacturability, process mapping, identification of critical characteristics, operational definitions, identification of responses/measurements/metrics, critical thinking skills, and 8D.
4 Do new product/process/technology/service development policies and procedures exist and do they
result in clearly defined project plans with appropriate metrics and approvals?
Considerations:
a. Policies and procedures exist which define minimum requirements appropriate resources and expectations for the development, introduction and manufacturing of new products, new/changed significant processes, technologies and services. These policies and procedures also define responsibility for implementation.
b. Qualified personnel who are adequately resourced are assigned to each project.
c. Existing policies and procedures assure that new products, technologies and services meet established performance goals, including cycle time goals and measurements, prior to introduction.
d. Policies and procedures require appropriate management visibility and approvals prior to committing new products, new/changed significant processes, technologies and services to production.
e. The organization complies with all provisions of their new product, new/changed significant processes, technology and service policies and procedures.
5 Is the capability of each operation, which controls critical-to-function characteristics for new products, fully qualified?
Considerations:
a. Cp’s and Cpk’s, or error rates of critical processes used to produce new products are fully quantified and qualified before production volumes are produced.
b. Statistical data is collected and used to control and improve these processes.
6 Are computer simulation and design tools used to the maximum extent practicable in the design of new products/technologies/services?
Considerations:
a. State of the art simulation models are used for the development of new products/services.
b. Tools, such as: Computer Aided Design (CAD), Computer Aided Manufacturing (CAM) and Simulation Modeling (S/M), are used to minimize development cycle time and improve quality.
7 Has a system been established with the supplier for identification and verification of corrective action?
Considerations:
a. The system includes the use of formal corrective action requests and enables follow-up on supplier’s corrective actions.
b. The system includes a method of preventing reoccurring defects.
c. The system includes verification of formalized methods of problem solving by suppliers
d. All records pertaining to supplier corrective actions are retained as quality records.
8 Is there an effective supplier certification program or equivalent supplier continuous quality improvement program?
Considerations:
a. There is a system for certifying suppliers.
b. There is a process which ensures continuous quality improvement of procured products and services and the rewarding of suppliers for their involvement in the programs
c. The system allows for customers to verify supplied product conformance to requirements either on site or at the supplier’s site when required by the purchasing documents.
d. Procedures are in place to identify, collect, file, store and dispose of all records pertaining to supplier certification.
9 Is the product or subassembly, and process to produce it routinely reviewed and are goals/plans established to continually improve at the required rate?
Considerations:
a. The organization regularly reviews performance of critical manufacturing metrics (quality, cycle time, on time delivery, product audit or reliability performance, equipment maintenance, SPC, process change management, and scrap) with management. Typical metrics are in Sigma, PPM, TDU, or DPU. b. Process goals are set using Quality Functional Deployment (QFD) or equivalent methodology.
b. Quality/Process improvement and cycle time reduction plans are in place. Product, subassembly, and process improvement results are in line with corporate/organizational improvement goals and customer requirements.
c. Quality metrics and management reviews records are maintained as Quality Records.
10 Does a system exists to assure that purchased materials, as received, conform to documented requirements prior to use?
Considerations:
a. There is a documented policy to assure conformance to requirements for purchased products. The policy may include such items as incoming inspection, supplier certification or other applicable methods.
b. Suppliers have documented procedures for verifying and recording product conformance to requirements prior to shipment, i.e., outgoing product inspections.
c. The system assures that purchased products conform to product design, manufacturing and other applicable requirements prior to use.
d. Any exceptions to the purchased conformance policies must be fully documented for subsequent trace ability if necessary.
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mark (威望:1) (广西 南宁) 贸易或进出口 经理
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