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polyster membrane circuit foil for medical device
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Product Details
| Model Number | 548-66 |
Product Description
polyster membrane circuit foil for medical device
Product Overviews-6
Application
Quality Control
QUALITY CONTROL MANUAL | |||||||||||
| 1. FORE WORD | |||||||||||
| The purpose of this manual being established is to describe the general functions of Quality Control Department. QC Dept. has to take the quality responsibility of purchased/consigned material and finished goods, which includes products working in process to ensure product’s quality & reliability. So that the material incoming quality, in process quality auditing and outgoing quality control will be the major functions of QC Dept. For each function, the system/inspection standard will be issued separately to accomplish the quality control/assurance with necessary records or reports pending on customer’s quality requirement. This manual is subject to be reviewed by manager of QC Dept. or his designated representative whenever it is necessary.
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| 2. ORGANIZATION | |||||||||||
| 2-1 Purpose: Sampling Plan | |||||||||||
| Quality Control Department is organized for the purpose of ensuring product quality and reliability consistent with customer’s requirements and maintaining a system of surveillance to enable performance of this function. | |||||||||||
| 2-2 Responsibility | |||||||||||
| Quality Control Department consists of 3 groups. They are (1)Material incoming quality control (2) In-process quality control (3) Quality assurance. The responsibilities of each groups are defined. | |||||||||||
| 2-2-1 Material Incoming Quality Control | |||||||||||
| (1) To perform new material evaluation and qualification. (2)To perform incoming inspection of all direct and indirect materials. | |||||||||||
| 2-2-2 In-process Quality Control | |||||||||||
| Whenever the material to be input to production line, the inspector of this group has to check/audit the quality in each major stations as material preparation, material thickness, shearing stabilizing, punching printing etc., with inspection standard to ensure right equipment conditions, proper operation, and good product quality. | |||||||||||
| 2-2-3 Quality Assurance | |||||||||||
| (1) To ensure compliance of finished product with customer’s quality requirements. (2)To perform the outgoing inspection after packing to release for shipment. (3)To be responsible for acceptance planning (sampling place), data collection, analysis and reporting, corrective action and associated process control programs to ensure optimum control of quality through the whole production lines. (4)To review and analyze all quality related compliance and returns from customers. Responsibilities including determining failure mechanism, cause for failure, corrective action, recommendation and corrective action follow-up. | |||||||||||
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| 3. INCOMING QUALITY CONTROL | |||||||||||
| 3-1 General | |||||||||||
| (1)For the purpose of keeping incoming material and parts above the minimum acceptable quality level (AQL), all production material purchased or consigned for production will be subjected to inspection. And/or tasted by incoming quality control (IQC) inspection and test will be performed according to specified engineering drawings and specifications. (2)MRB (Material Review Board) is the committee to decide the disposition of the discrepant material found by IQC. (3)Waive of material should be granted by either the head of MRB or the person who are authorized to waive the lot of material. Waive procedure should be followed by all concerning persons. | |||||||||||
| 3-2 Sampling plan | |||||||||||
| (1) According to ANSI ASQ Z1.4 -2008 STANDARD ,LEVEL II, SINGLE SAMPLING (2)Acceptable quality lever: Critical Defect: 0.4 % ; Major Defect : 0.65 % ; Minor Defect : 1.0 % | |||||||||||
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| 4. IN-PROCESS QUALITY CONTROL | |||||||||||
| 4-1 General: | |||||||||||
| (1)Purpose: To ensure that the working standard laid down by the engineering and quality dept are religiously followed so that defects may be prevented or detected early. This also enable corrective action to be taken in the earliest possible moment to counter the problems detected (2)Scope. All on-line gate inspection and in-process audit check belongs to in-process quality control. (3)Feedback quality information in time is the key point of in-process control. It can keep production flow with normal condition and minimum loss. | |||||||||||
| 4-2 Sampling Plan: | |||||||||||
| (1) Lot: Usually 2 hour production quantity will form one lot, however it is fllexible on needed. | |||||||||||
| 4-3 Work environment control: | |||||||||||
| PRINTEC created ESD rooms and clean rooms about ESD and cleanness control. (CLEAN ROOM :100,000 CLASS ; 10,000CLASS ; 1000 CLASS) | |||||||||||
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| CLEAN ROOM | ESD ROOM | Package | Inspection |
| 5. OUTGOING ACCEPTANCE INSPECTION | |||
| 5-1 General | |||
| Though the controls of IQC, IPQC and production are to ensure the quality level of our products, it is indispensable for quality assurance to perform outgoing acceptance inspection to finished products prior to shipment. This is a prime QA function to control outgoing products at an acceptable quality level. | |||
| 5-2 Sampling Plan | |||
| (1)According to ANSI ASQ Z1.4 -2008 STANDARD ,LEVEL II, SINGLE SAMPLING (2)Acceptable quality level: Critical Defect : 0.4% Major defect : 0.65% Minor defect : 1.0% | |||
| 5-3 Shipment Control | |||
| Quality assurance issues "Shipment Release Notice" to production control to release the shipment based on the QA inspection result. QA people should personally audit outgoing of the shipment by checking lot number, quantities in accordance with QA inspection report. |
Certifications
Company Information
Contact Us
- PRINTEC H. T. ELECTRONICS CORP.
- Contact nameClaire Li Chat Now
- Phone886-2-82277899
- AddressNo. 38
Product Categories
| DFM (Design for Manufacturing) | EL Lamp | Medical Sensor | Membrane Switch |
| Metal Keypad | New Products | Overlay/Labels Nameplates | RFPC/PCB Assembly |
| Rubber Keypad | Touch Panel | Turn-Key Solution |
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