Big Time验厂质量审核问卷
2018-03-03
Big Time验厂质量方面审核问卷内容包括:
A. Management Responsibilities (管理职责)
1.Does the factory has a Quality Policy? Is it posted? Do all the employees know what the policy is or where it is posted? How does the factory measure quality? Do the measurements support the Quality policy of the company?
1.1 What type of reviews of the quality system and quality reports are preformed by management? What actions are taken to correct issues and improve the measures? How are these documented?
1.2 What is the company’s plan to improve quality? Is it re-active or pro-active?
1.3 Does the company have sufficient resources and dedicated resources to measure and drive improvements in quality and productivity?
B. Continuous Improvement (BIGTIME验厂持续改进)
1.Does the factory measure the quality performance and the projects associated with reducing the defects? How is it communicated to the employees (posted, visuals, meetings, etc.)
1.1 How is the factory driving the improvements and is management involved in the process?
1.2 Review the plan to improve lead time
1.3 Review the communication process. Process must be pro-active and allow sufficient time for BTP to react. (Eg. Notification on the due date that the product is not shipping is not acceptable)
1.4 Review the training program. Does the training provide the operators with the tools and knowledge to improve the process?
1.5 Review the customer complain system. Are the complains recorded? Are actions taken to solve the problems? Does the factory follow up? Are improvements recorded?
C. Quality System(品质体系)
1.Does the factory have a QC Manual? What program does it follow (ISO, QS, Guide 53, etc.)
1.2 Does the factory have a process for design, testing, inspection, sampling, etc and can produce documentation to support this from product launches and production?
1.3 Review the process and documents that the supplier uses to sample products and submit inspection reports (review examples): FMEA, Control Plans, Gauge R&R studies, Sampling and process capability studies
1.4 Have the Key / Critical characteristics been identified and communicated throughout the organization
1.5 How does the factory control updating prints and manufacturing process documents and processes when changes are received from BTP or when approvals are received from BTP acknowledging a change. What processes are in place to notify BTP of changes and to control the processes and product until the changes are approved?
1.6 What methods are used in the factory to solve problems and have employees been trained in the techniques?
1.7 Review the system, how customers are notified of changes and how the approval is obtained.
1.8 Review the inspection reports from prior production, the processes in place to capture the data and verify the measurements.
1.9 See evidence of an internal auditing process Are findings noted? Are corrective actions driven from findings?
D.Purchasing(采购):
1.Does the factory have a supplier certification program for its suppliers?
1.1 Review the process of how the factory specifies and controls the quality of their incoming product from suppliers. Does the factory has a continuity of supply of raw material at stable prices (do they have a sufficient supply of raw material to support production and do they have a plan for fluctuations).
1.2 Is the program based on the quality of service, on time delivery, lead time and price ?
1.3 Does the factory has a program in place to improve the quality of the product and service (for all areas) to BTP and from its suppliers? If not, what are they doing to improve the service to BTP and from their suppliers? How does the factory verify purchased product and is the process adequate to ensure that no defects will go through their system and reach BTP?
1.4 Does the factory require and have material certifications for all critical products used to manufacture parts for BTP? What examples are required in your purchase agreements and what you have on file for specific product.
1.5 How does the factory control changes from/between their suppliers? Look at examples of this process. How does the factory control our tooling in house, at the sub-supplier, and between sub-suppliers? What methods are in place to ensure BTP is notified prior to any tooling movement or modification?
1.6 Review the product control coming into the supplier’s facility. How is it labeled? Is it clear what it is, when it was made, etc? Can the factory segregate and trace the product if a problem is discovered in the process?
1.7 Does the factory has an inventory system? Does the factory do inventory cycle counts to verify inventory accuracy? Does the factory knows supplier lead times and use it for purchasing?
1.8 Does factory has a production forecast? Does factory provide suppliers with the production forecast? Does factory update the forecast periodically? Do they communicate it to their suppliers?
E.Inspection & Test- Process Control(BIGTIME验厂检验和试验过程控制):
1.Does the factory have a process control plan or a process flow charts describing the manufacturing process?
1.1 Are the inspection points identified for the critical specs?
1.2 Is there a documented plan for containment of out of spec product and a reaction plan when out of spec parts are found?
1.3 Does the factory have a documented set up procedure with parameters? How does the factory verify the first piece and during production inspection?
1.4 Are these monitored and recorded during production? What are the reaction plans for out of control and out of spec conditions?
1.5 What is the procedure / process for verifying dies and tooling prior to running?
1.6 Are there scheduled PM sessions or is the tooling verified prior to run or after being removed from a run?
1.7 Does the factory has List Of Materials for the products they make? Are the list of materials accurate to the sales?
1.8 Can you stop the line in the event that they discover an out of spec or trending condition?
1.9 Is the final product identified properly?
2.How does the supplier ensure that the product is labeled correctly?
2.1 Can the product be traced back to raw materials used?
2.2 Product ID :Part number, manufacturing date, lot number, heat number, P.O. number, etc. Parts should be identified to allow THD to identify groups of defective product.
2.3 Does factory considers the capacity when planning production?
2.4 Does factory considers inventory on hand and orders when planning production? Does factory track daily production?
2.5 Does factory records daily production? Does factory has metrics to monitor scrap and rejected materials and products?
2.6 Are scrap, rejected material and products accounted for and properly disposed of?
2.7 Does factory has a preventive maintenance program that includes daily, weekly and monthly maintenance? Look for night time records.
2.8 Does factory have work instructions? Does the work instruction reflect what the operator is doing?
2.9 Are inspections consistent with the process charts? Are inspection requirement consistent with the process stage of the product? Are in process inspections documented? Is there any metrics of the in process inspections? (Pareto charts, control charts, etc)
3.Does the factory has a procedure to obtain samples from production? Does the procedure describe the inspection and the acceptance criteria? Does the procedure describe a course of action for non conforming/rejected products?
3.1 Does the factory have a finish product inspection procedure in place? Does the procedure define inspection criteria is according to product specifications? Does it includes packaging?
3.2 Are final inspection results recorded?
F.Control of Test Equipment(试验设备的控制):
1.Are the operators trained in the use of the gages? Is there documented evidence of this?
1.1 Will gages and measurement equipment ensure conformance to BTP specs? Are the gages capable of the measurements required (1 decimal place more than the spec)?
1.2 Check several gages for calibration. Check night time records.
1.3 Do you have a calibration schedule?
G. Control of Non-conforming (rejected) Product (不合格产品的控制(拒绝)) :
1.1 Is non-conforming product handled? Is it segregated from good product?
1.2 Are the defects recorded and tracked?
1.3 Is there a process for reviewing defective/suspect product?
1.4 Do you have a process to review non conforming products? How do identify, rework, scraps, documentation and corrective actions in place?
H. Corrective & Preventive Action(纠正及预防措施):
2.1 Is there a corrective action system in place to deal with customer issues? Is it the same as the internal system? Is it sufficient to document the issue, correct the problem, and ensure that is does not re-occur?
2.2 Is there a method to ensure that issues do not remain open?
2.3 Are implements corrective actions, verified to be effective?
2.4 Are changes to the process implemented in the daily production?
2.5 Are there training and signoffs for the training?
I. Document Control(Big Time验厂文件控制):
1.1 Do you have a method of controlling your documents, issuing revisions, destroying old documents, etc?
1.2 Is there a document sign off procedure in place? Are all departments involved?
J. Handling, Storage, Packing and Delivery(搬运,储存,包装和交付):
1.1 Do they have a process to identify each part? (handling, storage, packing, and delivery)
1.2 Is there possibility these departments can mix during production?
1.3 Can defective parts , or product be used?
1.4 Is final packing/packaging checked before shipment?
1.5 Do they check to be sure meets BTP spec?
1.6 Do they have a process in place for wrong packing (sticker. Labels ect ) in place to correct problem if occurs?