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Location: <enter supplier location> Assessor: <enter Lead Assessor name> Date: <enter first day of assessment> Process:
Score Comments 0 4 6 8 10
Q.
Question
1.3
Is a Product Development Plan available and are the prescribed aims [targets] adhered to?
Has the Design FMEA been prepared and are the improvement actions defined?
1.4
2. Process Development
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Location: <enter supplier location> Assessor: <enter Lead Assessor name> Date: <enter first day of assessment> Process:
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Question
2.1
Amendments to the product and process must be evaluated by the project management. In agreement with the FMEA Team, a new analysis, if necessary, is to be initiated. An update is also necessary after realization of measures (Design Review). The following points, for Has the Design FMEA been updated during example, are to be considered: - Customer requirements the Project Course and have the defined - Important parameters/characteristics, legal requirements actions been implemented? - Function, fitting measurements - Material - Environmental aspects - Transport (internal/external) - Product-specific measure from the process FMEA. TS: 7.3.4
The releases/qualification records of all individual parts, subassemblies and purchased parts are to be proven. The following points, for example, are to be considered: - Product trials (e.g. fitting inspections [do parts fit in assembly/application], functional tests, durability checks, environmental simulations) - Status of the prototype parts - Pilot series model - Production/inspection, measuring and test equipment in experimental installation.
2.3
Has a pre-production run been carried out prior to full scale production, under full scale production conditions?
TS: 7.3.6.3
A pre-production is required to be able to evaluate and, if necessary, correct all production factors and influences at an early stage. In serial production [after job 1, after PPAP, full], bottlenecks and quality impairment [scrap and rework], shall become avoidable [corrective actions are effective]. The following points, for example, are to be considered: - Customer requirements - Establishing minimum numbers of production pieces - Process capability analysis - Measuring equipment capability - Readiness of the production materials and equipment for series [after job1, after PPAP, full] (measuring records,[evidence] - First sample inspection - Handling, packaging, marking and storage - Personnel qualification - Work/Inspection instructions - Arrangement of work/inspection stations.
2.4
Process parameters/inspection characteristics are always to be given with tolerances, the production and inspection documents must be available at the work/inspection station. The implemented corrective actions for nonconformities are to be documented. Details are, for example: - Process parameters (e.g. pressures, temperatures, times,speeds) - Machine/tool/auxiliary means data Are the procuction and inspection - Inspection requirements (important characteristics, inspection, measuring and test documents available and complete (PPAP)? equipment, methods, inspection frequencies) - Intervention limits in process control charts [control limits] - Machine and process capability records - Operating instructions - Work instructions - Inspection instructions - Information on the current nonconformities. [non conforming material is documented and TS: 7.3.3.1, 7.3.6.3, 7.5.1.2, 7.5.3.2 tracked] - [PPAP]
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Location: <enter supplier location> Assessor: <enter Lead Assessor name> Date: <enter first day of assessment> Process:
Score Comments 0 4 6 8 10
Q.
Question
B. Production Process
3. Supplier Management
The supplier must have established criteria for selection and re-evaluation of their subsuppliers. Sub-suppliers must be qualified to meet the suppliers' customer requirement. Records of assessment results, if any, corrective actions and quality performance must be kept.
TS: 7.4.1, 7.4.1.2 The following points, for example, are to be considered: - Sufficient inspection and test possibilities (capabilities, lab scope) Laboratory and measuring equipment) - Internal/external inspections and tests - Supplied gauges/surveys - Drawings/order details/specifications - Quality assurance agreements [ppm, delivery] - Coordination of inspection and testing procedures, proceedings and frequencies [control plan] - Analysis of nonconformity focal points [scrap analysis] - Capability evidence. [reviewed and analyzed]
3.3
Is the quality performance evaluated and are corrective actions introduced when there are deviations from the requirements?
The capabilities and performances of a supplier are to be checked at defined intervals and recorded and evaluated in a part-specific listing (supplier catalog) [supplier score card]. Qualification programs [supplier remedial activities and monitoring] are to be established when negative results are found. The implementation [and effectiveness] is to be proven [validated]. The following points, for example, are to be considered: - Records about quality meetings [minutes and action item list] - Agreements [supplier buy-in] about and monitoring of improvement programs - Inspection and measuring records of improved components [e.g PPAP] - Analysis of nonconformity focal points/problem suppliers.
3.4
The releases/qualification records of all individual parts, subassemblies and purchased parts, production, inspection , measuring and test equipment, are to be proven. The following points, Are the necessary releases available for all for example, are to be considered: - Product trials (e.g. fitting inspection (dimensional, into assembly/application), functional test, the supplied products and are the necessary improvement actions converted durability check, environmental simulations) - Pilot production parts into practice? - First sample - Capability records of important product/process characteristics - Logistic concept (e.g. checking suitability of packaging by a test dispatch) - Tools, machines, equipment, inspection, measuring and test equipment. TS: 7.3.5, 7.3.6
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Location: <enter supplier location> Assessor: <enter Lead Assessor name> Date: <enter first day of assessment> Process:
Score Comments 0 4 6 8 10
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Question
Are the stock levels of purchased material suited to the production requirements?
3.5
TS: 7.5.1.6
The required stock levels must already be determined and considered during process planning. When requirements change, the analyzed stock levels, if necessary, are to be updated. The following points, for example, are to be considered: - Customer requirements - KANBAN/Just in time - Storage costs - Emergency strategy when input material bottlenecks occur [contingency plan, expedited shipments] - FIFO (first in/first out).
3.6
The following points, for example, are to be considered: - Packaging - Storage administration system [Warehouse management, MRP/ERP system] Are purchased materials/internal surpluses - FIFO (first in/first out) - Tidiness and cleanliness [housekeeping, 5S] delivered and stored according to their - Climatic conditions [ambient conditions] purpose? - Protection against damage/contamination [preservation] - Identification - (Traceability/Inspection status/Sequence of operations/Application status) - Safety against mix ups [prevention] - Secure storage (fitted and used). [finished goods, WIP] TS: 6.2.1, 6.2.2, 7.5.5.1 Personnel responsible for the following areas, for example, are to be considered: - Supplier selection, evaluation, qualification - Product inspection, measuring and testing - Storage/Transport - Logistics. Is the personnel qualified for the individual Knowledge must be available, for example, about: tasks? - Product/specifications/special customer requirements - Standards/legislation - Packaging - Processing - Evaluation methods (e.g. audits, statistics) - Quality techniques (e.g. 8D-Method, Cause/Effect diagram) - Foreign languages. TS: 6.2.2.2
3.7
B. Production Process
The following points, for example, are to be considered: Are the employees given responsibility and - Cooperation on improvement programs (participation) - Worker self assessments (self audit, operator TPM) authority for monitoring the - Process approval/release 4.1.1 product/process quality? - Set up release/First/last production piece testing / inspection) - Process control (Interpretation of control charts) - Authority to stop production. TS: 5.5.1.1
Are the personnel responsible for production equipment and the production 4.1.2 environment?
The following points, for example, are to be considered: - Tidiness and cleanliness [housekeeping, 5S] - Carrying out or ordering repair and maintenance work - Providing parts/storage - Carrying out/ordering the installation and calibration of inspection, measuring and test equipment.
TS: 6.2.2.4
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Location: <enter supplier location> Assessor: <enter Lead Assessor name> Date: <enter first day of assessment> Process:
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Question
Are the employees suitable to perform the required tasks and is their qualification 4.1.3 maintained?
The following points, for example, are to be considered: - Introduction/Training/Qualification records about the process - Knowledge of the product and nonconformities which have occurred - Instructions in health and safety at work/Environmental aspects [MSDS, OSHA, ISO 14001] - Instructions for the handling of components with special verification requirements [special characteristics] - [Operator] Qualification records (e.g. Welder certificates, sight tests [vision, color], driving license for industrial trucks).
When planning personnel, the absentee figures (illness/holidays/[vacation]/training courses) are to be considered. The required qualifications of replacement personnel are also to be ensured. The following points, for example, are to be considered: - Shift plan ([Union] contract related) - Qualification records (Qualification matrix) [compentency] - Work analyses/Time and motion studies.
TS: 6.2.2.2
TS: 6.2.2.4
The willingness to work [morale, commitment] must be promoted through targeted information and thereby, the quality awareness increased. [information sharing] The following points, for example, are to be considered: - Quality information (Specified/Actual values) - Improvement suggestions - Voluntary activities (Training courses, quality circles, [first responder] - Low illness frequency rate - Contribution to quality improvement - Self assessments. Comment: The question also stands in connection with question 7.5. [see question 5.5]
B. Production Process
Are the product related quality requirements guaranteed using the 4.2.1 production equipment/tools?
TS: 8.2.2.3
Can the quality requirements be monitored effectively during serial production with the implemented inspection, measuring and 4.2.2 test equipment?
The following points, for example, are to be considered: - Reliability, function and corrosion resistance tests [preservation] - Measuring accuracy/inspection, measuring and test equipment capabilities - Data acquisition [Quality records, process data] and analysis - Calibration records.
TS: 8.2.3.1
Is there a Gage Management System and Measurement System Analysis for production equipment and devices ? Do 4.2.3 they execute it and is it effective?
The following points are to be considered: - MSA manual latest revision available, - MSA study results (R&R, Linearity, Bias, Stability) are available, - MSA results are analyzed and corrective action are initiated, - Criteria for frequency of study are defined. - Equipment is calibrated with traceable standards Draft 5 of 11
Location: <enter supplier location> Assessor: <enter Lead Assessor name> Date: <enter first day of assessment> Process:
Score Comments 0 4 6 8 10
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Question
Are the work places, inspection areas and test areas suited to the requirements?
4.2.4
The environmental conditions (also for repairs/rework) are to be tuned [appropriate] to the work contents and the products, to avoid contamination, damage and mix up / misinterpretation. The following points, for example, are to be considered - Ergonomics - Lighting - Tidiness and cleanliness [housekeeping] - Environmental protection [work area, noise, contamination] - Surroundings/Handling of the components - Health and safety at work.
Process parameters and inspection and testing characteristics are always to be given with tolerances. Manufacturing and inspection documents must be available at the work/inspection stations. Nonconformities and implemented corrective actions must be documented. The following points, for example, are to be considered: Are the relevant details fully completed and - Process parameters (e.g. pressures, temperatures, times, speeds) adhered to in the production and inspection - Machine/tool/auxiliary means [perisable tooling] data (Tool and machine numbers) - Inspection requirements (important characteristics, inspection, measuring and test 4.2.5 documents? equipment, methods, frequencies) - Intervention limits [Control limits] in process control charts - Machine and process capability records - Operating instructions - Work instructions - Inspection instructions - Information on the current nonconformities [log, check list] TS: 7.5.1.2, 8.2.4, 8.3, 8.3.1
The following points, for example, are to be considered: - Tooling plans - Tool setting aids/comparison aids [checking aids] - Flexible tool change equipment - Limits patterns [SPC out of control conditions]
TS: 7.5.1.5
The following points are to be considered: - list of critical equipment, - is there a plan and is plan followed?
TS: 7.5.1.4 Has a list with critical equipment and critical parts been established and up to 4.2.8 date? TS: 7.5.1.4
The folloing points are to be considered: - critical equipment has a list with repair parts
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Location: <enter supplier location> Assessor: <enter Lead Assessor name> Date: <enter first day of assessment> Process:
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Question
Is an approval for production starts issued and are adjustment details, as well as 4.2.9 deviations recorded?
TS: 7.5.1.3
Corrective actions relate to the entire process chain, from input material through to use by the customer. The effectiveness of corrective actions carried out, must be checked and proven. The following points, for example, are to be considered: Are the corrective actions implemented and - Risk analyses (Process FMEA) Fault analyses checked for effectiveness? - Improvement programs from audits 4.2.10 - Information to the responsible party - Interface discussions internal/external - Internal complaints - Customer complaints - Customer surveys TS: 8.5.2
B. Production Process
The following points, for example, are to be considered: - Sufficiently suitable transport means [internal, between processes, to/from warehouse] - Defined storage areas - Minimal/no intermediate store [minimize WIP] - KANBAN Are the quantities/ production lot volumes - Just in time matched to demand and are they conveyed - First in/first out 4.3.1 in a targeted manner? - Storage administration [inventory management] - Modification status [Rework / in-process status identified] - Only transfer of satisfactory parts [only good parts go downstream] - Recording production pieces numbers/evaluation [production and inspection results] - Information flow. Comment: When material/purchased parts are delivered directly to the respective production plants, the requirements according to question 3.7 are also to be considered. TS: 7.5.1.6
Are products/ components stored according to their purpose and are the transport method/ packaging equipment matched to 4.3.2 the special characteristics of the products/ components?
The following points, for example, are to be considered: - Stock levels - Protection against damage - Parts positioning - Tidiness, cleanliness, [housekeeping, 5S] overstocking (storage areas, containers) - Monitoring of the storage time [shelf life monitoring] - Environmental influences, air conditioning. [storage conditions] Comment: When material/purchased parts are delivered directly to the respective production plants, the requirements according to question 3.5 and 3.6 are also to be considered. Draft 7 of 11
Location: <enter supplier location> Assessor: <enter Lead Assessor name> Date: <enter first day of assessment> Process:
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Question
TS: 7.5.5.1
Are reject, re-work and setup parts conscientiously separated and identified?
4.3.3
The following points, for example, are to be considered: - Holding store, holding areas - Marked containers for rejects, rework parts and adjustment parts - Nonconforming products and nonconformity characteristics - Identification/marking - Defined transfer/rework stations in the production department.
Appropriate to the product risk, the traceability along the entire process chain from supplier to customer, must be guaranteed. The following points, for example, are to be considered: Is the material and parts flow secured against mix-up/confusion and is traceability - Identification/Marking of parts - Identification/Marking of the operational, inspection and test and application status 4.3.4 guaranteed? - Batch/heat numbering - Expiry date - Removal of invalid identification/marking - Working documents with parts/production data. TS: 7.5.3, 7.5.3.1, 8.3
Tools, machinery, inspection, measuring and test equipment, not in use and not released, must also be correctly stored and administrated. The following points, for example, are to be considered: Are tools/ equipment and test and - Storage without risk of damage inspection equipment stored appropriately? - Tidiness and cleanliness [housekeeping, 5S] 4.3.5 - Defined storage location - Administered issue [controlled release from storage] - Environmental influences [on storing of tools, machinery, etc] - Identification/Marking - Defined release and revision status. TS: 7.5.1.5, 7.6
The following items should be considerd: - does the supplier have a copy of the customer's packaging requirements?, - are the requirements being followed? - does supplier have an access to the latest D13 specification?
B. Production Process
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Location: <enter supplier location> Assessor: <enter Lead Assessor name> Date: <enter first day of assessment> Process:
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Question
Are the quality and process data statistically analysed and improvement 4.4.2 programmes introduced?
Findings and problem points are to be related [forwarded] to the responsible departments, which must then work out and implement improvements. The following points, for example, are to be considered: - Process capabilities - Failure modes/failure frequencies - Nonconformity costs - Process parameter - Rejects/rework - On hold notifications/Sorting actions - Cycle, through put/processing times - Reliability/Failure conduct. The following, for example, can be used: - SPC - Pareto Analysis - Cause/effect diagrams
When product/process failures have occurred, appropriate immediate actions (such as placing on hold, sorting, informing, [containment]) must be carried out, to ensure compliance with the requirements, until the cause of the failure has been removed and the effectiveness of Are the causes analysed and the corrective corrective actions has been proven. The following points, for example, are to be considered: actions checked for effectiveness in the - Additional dimensional, material, functional, endurance tests case of deviations from product and - Cause/effect diagram 4.4.3 process requirements? - Taguchi, Shainin - FMEA/Fault analysis - Process capability analysis - Quality Circle - 8D-Method. TS: 8.3, 8.5.1.2, 8.5.2, 8.5.2.1 Audit plans for the product and its manufacturing process must be available. Audit reasons are, for example: - New projects/processes/products - Nonconformity with quality requirements (internal/external) - Maintaining records of the compliance with quality requirements - Identifying improvement potentials. Nonconformity reports (NCRs) are to be distributed to the responsible parties, the improvement measures are to be monitored. The following points, for example, are to be considered: - Customer requirements - Important characteristics - Function - Process parameters/capabilities - Marking/identification, Packaging - Established processes/procedures.
The improvement potential must be determined from previous findings about quality, costs and service [delivery] The following points, for example, are to be considered: - Cost optimization - Reduction of waste (e.g. rejects and rework) - Improving of process safety [variation reduction] (e.g. process analysis) - Optimizing set-up times, raising plant availability [uptime] - Reducing through-put/processing times - Reducing stock levels.
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Location: <enter supplier location> Assessor: <enter Lead Assessor name> Date: <enter first day of assessment> Process:
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Question
Target parameters must be agreed and feasible, the topicality [current and correct version] is to be guaranteed. Special measures required are to be established and implemented, if necessary. The following points, for example, are to be considered: Are targets set for the product and process - Presence and absence of personnel and are these monitored? - Number of production pieces produced 4.4.6 - Quality indices (e.g. failure rates, audit results) - Through-put/processing times - Nonconformity costs - Process characteristic values (e.g. process capability). TS: 8.2.3.1, 8.2.4
B. Production Process
TS: 8.2.2.3, 8.2.4, 8.2.4.1 It is to be guaranteed, that competent contact people for the various organization departments of the customer are available. Customer support is also a measure of active cooperation. The sub-supplier has the duty to observe and, if necessary, improve, his products across all development and application phases. The following points, for example, are to be considered: - Records of customer visits, if necessary, deriving measures [corrective actions] - Knowledge of product application - Knowledge of product problems - Implementation of new requirements - Notification of improvement measures - Notification of product/process changes/redeployments, (also of suppliers) - First/repeat samplings (Trial/Series) - Information about nonconformities.
The following items should be considered: - contingency plans for product/equiment/utilities/manning issues, - capability of and reaction to containment activities
TS: 6.3.2
The following points, for example, are to be considered: - Analysis possibilities [capabilities] (Laboratory, inspection/test equipment, personnel) - PARETO Analyses of failure characteristics (internal/external) - Involvement of all affected departments (internal/external) - Use of problem solving methods (e.g. 8D Report) - Correction of sampling deviations - Revision of the specifications - Check [verification] of effectiveness.
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Location: <enter supplier location> Assessor: <enter Lead Assessor name> Date: <enter first day of assessment> Process:
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Question
Responsible personnel, for example, for the following areas are to be considered: - Customer service - Product inspection and testing - Storage/Transport - Logistics - Fault analysis. Knowledge [Compentency] of the following, for example, must be available: - Product/specifications/special customer requirements - Standards/Legislation - Processing/Application - Evaluation methods (e.g. audit, statistics) - Quality techniques (e.g. 8D Method, Cause/effect diagram) - Foreign languages.
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