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quality management

Quality management program file

Quality sampling method

1. General

1. 1 formulation purpose

In order to save inspection costs and effectively control the quality of raw materials and finished products, these measures are formulated.

1.2 Scope of application

The quality control unit of our company conducts various sampling inspection operations in accordance with these measures.

1.3 authority and responsibility unit

(1) The Quality Control Department is responsible for drafting the formulation, revision and abolition of the Methods.

(2) The General Manager is responsible for approving the formulation, revision and abolition of these Measures.

2. Operating procedures

2. 1 sampling scheme

The sampling scheme of our company's quality inspection adopts GB2828 (equivalent to MIL-STD- 105D) for one sampling, with general inspection level II and special inspection level S-2.

2.2 inspection principle

(1) The sampling scheme of our company's quality inspection adopts special regulations, and all of them adopt a single normal inspection method.

(2) If it is necessary to adjust the inspection method, it shall be approved by the manager of quality control department or above.

2.3 Description of inspection mode conversion

2.3. 1 Reform approval process

(1) The application for tightening, relaxing or resuming the normal inspection shall be submitted by the Quality Control Department and approved by the manager of the Quality Control Department.

(2) The application for relaxing or resuming normal inspection put forward by the submitting unit shall be approved by the manager of quality management department or above.

(3) The manager of the Quality Control Department (inclusive) has instructed some inspection methods to be tightened, relaxed or returned to normal, and the Quality Control Department will implement them.

2.3.2 Conditions for Changing from Normal Inspection to Strict Inspection

In the normal inspection process, if more than five out of ten batches of continuous inspection (excluding two batches submitted for re-inspection) are judged as unqualified (rejected), the Quality Control Department may apply for stricter inspection instead.

2.3.3 Conditions for Changing from Strict Inspection to Normal Inspection

In the process of tightening inspection, when ten batches of continuous inspection are judged to be qualified (accepted), the quality control department can use the normal inspection party instead.

2.3.4 Change from normal inspection to relaxing inspection conditions.

In the normal inspection process, if ten consecutive inspections are judged as qualified (allowed), and the samples taken have no major defects (MA) and fatal defects (CR), the Quality Control Department or the submitting unit may apply for relaxing the inspection.

2.3.5 Conditions for changing from loose inspection to normal inspection

In the process of relaxing inspection, as long as a batch of unqualified products are judged (rejected), the quality control personnel should report to the manager of the quality control department and restore the normal inspection methods.

2.4 Schedule of comprehensive inspection

Under any of the following circumstances, with the approval of the manager of quality control department or above, full inspection can be adopted:

(1) When the submitted materials (finished products) have fatal defects (CR).

(2) When there are quality problems with safety defects or hidden dangers.

(3) There are many defects during warehousing inspection and processing.

(4) The quality is extremely unstable.

(5) When full inspection is required under other conditions.

Step 3 seize

[Attachment ]HA0 1- 1 sample code table

[Attachment ]HA0 1-2 Sampling Table

Incoming inspection procedure

1. General

1. 1 formulation purpose

In order to control the quality of purchased materials and outsourced materials, and make them meet the design specifications and acceptable quality standards, the Company formulates this regulation.

1.2 Scope of application

These regulations apply to all materials purchased by the company, outsourced materials or parts manufactured by the company.

1.3 authority and responsibility unit

(1) The Quality Control Department is responsible for drafting the formulation, revision and abolition of this Procedure.

(2) The general manager is responsible for approving the formulation, revision and abolition of rules.

2. Inspection regulations

2. 1 sampling scheme

According to GB2828 (equivalent to MIL-STD- 105D) single sampling scheme.

2.2 Quality characteristics

Quality characteristics are divided into general characteristics and special characteristics.

2.2. 1 general characteristics

Meet one of the following conditions, is a general feature:

(1) Those that are easy to check, such as appearance features.

(2) Quality characteristics have a direct and important impact on product quality, such as electrical performance.

(3) the quality characteristics change greatly.

Special features

Meet one of the following conditions, is a special function:

(1) The inspection work is complicated, time-consuming or expensive.

(2) Quality characteristics can be judged by referring to other characteristics.

(3) quality characteristics change little.

(4) Destructive test.

2.3 inspection level

(1) The general characteristics adopt the general level II of normal single sampling in GB2828.

(2) The special features adopt the special S-2 level of normal single sampling in GB2828.

2.4 defect level

Defects found in sampling inspection that do not meet the quality standards are called defects, and their grades are as follows:

(1) fatal defect (CR)

Defects that can or may endanger the life or property safety of product users and carriers are called fatal defects, also known as serious defects, which are represented by CR.

(2) Main defect (MA)

Defects that fail to meet the purpose of the product are called major defects or major defects, which are expressed by horses.

(3) Minor defects

Defects that do not affect the purpose of product use are called secondary defects or secondary defects, which are expressed by MI.

2.5 acceptable level (AQL)

2.5. Definition of1AQL

AQL (Acceptable Quality Leval) is the upper limit of acceptable rate of poor quality, also known as acceptable quality level, or simply acceptance level.

Acceptance grade

During the incoming inspection, the company's acceptance level of incoming materials with each defect level is as follows:

(1) chromium defect, AQL=0.

(2) Horse defect, = 1.0%.

(3) Myocardial infarction defect, AQL=2.5%.

The acceptance level of incoming materials should be stricter than or equal to the customer's acceptance level of finished products Therefore, if the customer's acceptance level of finished products is stricter than the above standards, the customer's standards shall prevail.

2.6 inspection basis

2.6. 1 electrical parts

Based on one or more of the following

(1) part specifications

(2) Parts confirmation report.

(3) Relevant inspection specifications.

(4) International and national standards.

(5) By comparing the approved samples.

2.6.2 Appearance, structure and packaging materials

Based on one or more of the following:

(1) technical drawings.

(2) Parts confirmation report.

(3) Relevant inspection specifications.

(4) International and national standards.

(5) By comparing the approved samples.

3. Operating procedures

3. 1 operating procedures

(1) The materials delivered by the supplier shall be collected by the warehouse keeper to check whether the materials, specifications and quantities are consistent, and then signed by the material quality control unit (IQC) for acceptance.

(2) The quality control personnel conduct inspection and judgment according to the sampling plan, and fill the inspection records in the Incoming Inspection Record Form.

(3) When the quality control personnel judge that the materials are qualified (accepted), they must put the receiving label on the appropriate position of the outer packaging of the materials, and add the inspection time and signature, and the warehouse management personnel and suppliers shall go through the warehousing procedures.

(4) Materials judged as unqualified (rejected) by quality control personnel shall fill in a notice of unqualified and submit it to the quality control supervisor for review and ruling.

(5) For the unqualified (rejected) materials approved by the quality control supervisor, the quality control personnel shall notify the supplier to return and improve through purchasing, and affix unqualified labels and signs on the outer packaging of the materials.

(6) For the unqualified materials determined by the Quality Management Department, the supplier or purchaser may apply to the Quality Management Department for special review or special procurement under the following circumstances:

(a) The supplier or the buyer determines that the judgment is wrong.

(b) When the material is urgently needed for production.

(c) When the defect has little influence on subsequent processing and production.

(d) Other special circumstances.

(7) The Quality Control Department rechecks the requirements of suppliers or procurement, and can make the following judgments.

(1) The quality control unit shall conduct spot checks again.

(b) Designate a unit to conduct a comprehensive inspection.

(3) Relax the standards for special purposes.

(d) use after processing.

Maintain an unqualified judgment.

(8) If items (c) and (d) specified in the preceding paragraph are judged to belong to the category of special mining (special acceptance), they shall be regarded as qualified products and put into storage, and the quality control department shall label them and track them.

(9) The supplier shall make necessary treatment within the time limit to meet the needs of the company, and then submit it to the Quality Control Department for re-acceptance.

(10)IQC shall keep the inspection records of each batch of materials, and use them as the assessment basis for supplier evaluation.

3.2 Materials that cannot be inspected

The quality control department can deal with the composition and characteristics of materials that cannot be inspected by our company as follows:

(1) The factory inspection records or quality guarantee provided by the supplier shall be regarded as qualified materials received by our company.

(2) The company entrusts an external inspection agency for inspection, and the expenses shall be borne by the supplier or shared by both parties.

(3) The supplier shall bear any loss or influence caused by the acceptance of qualified materials.

3.3 Other clauses

(1)IQC shall summarize the incoming inspection records on a daily, weekly and monthly basis, and form daily, weekly and monthly reports.

(2)IQC daily, weekly and monthly reports shall be submitted to the purchasing department for understanding, and sent to the general manager or competent deputy general manager when necessary.

(3) The self-made parts of our company shall be inspected as required by the above inspection regulations.

Step 4 seize

[attachment ]HA02- 1 incoming inspection record

[Attachment ]HA02-2 Notice of Non-conformance

[Attachment ]HA02-3 Daily Report of Incoming Inspection

Process inspection management program

1. General

1. 1 formulation purpose

This regulation is formulated in order to strengthen quality control and effectively control the quality of products during manufacturing and processing.

1.2 Scope of application

Unless otherwise specified, the quality control of the company's manufacturing process shall be implemented in accordance with these regulations.

1.3 Right current unit

(1) The Quality Control Department is responsible for drafting the formulation, revision and abolition of this Procedure.

(2) The General Manager is responsible for approving the formulation, revision and abolition of these Provisions.

2. Control clauses

2. 1 control responsibility

2.2. 1 Technology Department

Biotechnology Department has the following control responsibilities for process quality:

(1) Formulate reasonable process flow and operation standard.

(2) Provide complete technical data and documents.

(3) Maintain equipment and tooling to ensure normal operation.

(4) Check the implementation of operation standards and equipment usage at any time.

(5) Handle abnormal quality problems with the Quality Control Department.

2. 1.2 production department

The manufacturing department has the following control responsibilities for process quality:

(1) Operators should always check whether they meet the operating procedures and quality standards, that is, carry out self-inspection.

(2) The lower-level engineering (sequence) personnel have the responsibility to check and supervise the work quality of the upper-level engineering (sequence) personnel, that is, to conduct mutual inspection.

(3) Full-time inspection stations shall be set up in the assembly workshop of the company, and full-time personnel shall conduct full-time inspection on the workpieces according to the specified inspection specifications, so as to ensure that the important quality items of the products meet the standards, and make good records of defects.

(4) Cadres at all levels in the manufacturing department should check the operation quality from time to time, and promptly eliminate abnormalities or assist relevant departments to eliminate them.

2. 1.3 quality control department

The quality control department has the following control responsibilities for process quality:

(1) Send personnel (PQC) to inspect and guide each station one by one according to the specified inspection frequency and opportunity, and correct the operation, that is, conduct process inspection.

(2) Record and analyze the defective products found in the whole inspection station and inspection, and take necessary corrective or preventive measures.

(3) Find obvious or potential quality anomalies in time, and track the processing results.

2. 1.4.PQC working procedure

Process quality control personnel, also known as PQC (Process Quality Control), have the following working procedures:

(1)PQC personnel should know the next day's production plan of the manufacturing unit in charge before leaving work, so as to prepare relevant materials in advance.

(2) Before the manufacturing unit produces a certain product, PQC personnel should know and find the following relevant information in advance:

Manufacturing order.

(b) List of materials

(c) Technical drawings for inspection.

Check specifications and standards.

(e) process flow and operating standards

(f) quality history files.

Other relevant documents.

(3) When the manufacturing unit starts production, PQC personnel should assist the manufacturing cadres in wiring, mainly assisting in the following work.

(a) process inspection.

(b) Check materials and process fixtures.

(c) On-site inspection with measuring instruments.

(d) Guidelines on quality standards for operators.

(e) Inspection of the first product.

(4) After the production of the manufacturing unit is normal, PQC personnel shall conduct regular inspection according to regulations. The inspection time is specified as follows

At eight o'clock.

10:00

(C) 13:00 .

15:00 .

(e) 18: 00 (during overtime).

Or according to a certain batch (quantitative) inspection.

(5) When PQC inspection finds defects, it shall timely analyze the reasons and correct the unreasonable behavior of the operators.

(6)PQC shall promptly cooperate with the cadres of the manufacturing unit or full-time (part-time) maintenance personnel to deal with the defects of the full inspection station, analyze the reasons and formulate countermeasures.

(7) If PQC fails to handle major quality anomalies, it shall issue a Notice of Process Anomalies, which shall be reviewed by its supervisor and then notified to relevant units for handling.

(8) If major quality anomalies are not eliminated in time, PQC has the responsibility to ask the manufacturing unit to stop the production line (machine) and prevent it from continuing to manufacture defects.

(9)PQC shall record the inspection status in the process inspection record form in time and submit it daily.

2.3 Poor process control

2.3. 1 bad distinction

According to the source of bad products, it can be divided into the following categories:

(1) Poor operation

(a) operational error.

Poor management.

(c) equipment problems.

(d) Other defects caused by operation.

(2) The original materials are defective

(a) The purchased materials are initially mixed with defective materials.

(2) Poor processing of preliminary work.

(c) Other defects obviously caused by engineering or purchased materials.

(3) Poor design

Operating defects caused by poor design.

2.3.2 Calculation method of defective rate

(1) process defect rate

Process defect rate = (number of process defects/total output) × 100%

(2) Material defect rate

Material defect rate = (number of material defects/total material input) × 100%

Original defective rate of materials = (original defective number of materials/total input of materials) × 100%

Material operation defect rate = (number of material operation defects/total material input) × 100%

(3) Bad sampling rate (inspection process)

Sampling failure rate = (sampling failure number/total sampling number) × 100%

Step 3 seize

[Attachment ]HA03- 1 Process Inspection Record Form

[Attachment ]HA03-2 Inspection Daily of Full Inspection Station

[Attachment ]HA03-3 Process Exception Notification

Final inspection procedure

1. General

1. 1 formulation purpose

In order to strengthen product quality control and ensure the quality stability between projects, this regulation is formulated.

1.2 Scope of application

In the process of product processing in our company, when the products or finished products after the completion of each project need to be put into storage, these provisions shall apply.

1.3 authority and responsibility unit

(1) The Quality Control Department is responsible for drafting the formulation, revision and abolition of this Procedure.

(2) The General Manager is responsible for approving the formulation, revision and abolition of these Provisions.

2. Inspection regulations

2. 1 sampling scheme

According to (GB2828 (equivalent to MIL-STD- 105D) single sampling scheme.

2.2 Quality characteristics

Quality characteristics are divided into general characteristics and special characteristics.

One of the following conditions is a general feature.

(1) Those that are easy to check, such as appearance features.

(2) Quality characteristics have a direct and important impact on product quality, such as electrical performance.

(3) the quality characteristics change greatly.

Special features

Meet one of the following conditions, is a special function:

(1) The inspection work is complicated, time-consuming or expensive.

(2) Quality characteristics can be judged by referring to other characteristics.

(3) quality characteristics change little.

(4) Destructive test.

2.3 inspection level

(1) The general characteristics adopt the general level II of normal single sampling in GB2828.

(2) The special features adopt the special S-2 level of normal single sampling in GB2828.

2.4 defect level

Defects found in sampling inspection that do not meet the quality standards are called defects, and their grades are as follows:

(1) fatal defect (CR)

Defects that can or may endanger the life or property safety of product users and carriers are called fatal defects, also known as serious defects, which are represented by CR.

(2) Main defect (MA)

Defects that fail to meet the purpose of the product are called major defects or major defects, which are expressed by horses.

(3) Minor defects

Defects that do not affect the use of the product are called secondary defects or secondary defects, which are expressed by MI.

2.5 acceptable level (AQL)

The acceptance criteria of the company's final inspection defect level are as follows:

(1) chromium defect, AQL=0.

(2) Horse defect, = 1.0%.

(3) Myocardial infarction defect, AQL=2.5%.

2.6 inspection basis

Based on one or more of the following:

(1) technical documents.

(2) Relevant inspection specifications.

(3) International and national standards.

(4) Industry standards or association standards (such as TUV, UL, CCEE, etc.). ).

(5) customer requirements.

(6) Quality history documents.

(7) Compare samples.

(8) Other technical and quality documents.

3. Operating procedures

3. 1 Production batch inspection

(1) Every time a certain number of products (semi-finished products and finished products) are accumulated in the manufacturing process, the manufacturing unit shall send them to the Quality Control Department as a delivery batch (such as pallets) for inspection.

(2) The FQC (Final Quality Control) personnel of the Quality Control Department shall conduct sampling inspection according to the sampling regulations and fill in the Incoming Inspection Record.

3.2 Receiving and warehousing

(1) For products (semi-finished products and finished products) judged qualified (accepted) by FQC, the external packaging label shall be stamped with "qualified" seal and signed.

(2) The material personnel of the manufacturing unit fill in the receipt form, and after being signed by the quality control personnel, the qualified materials will be sent to the corresponding warehouse for warehousing formalities.

3.3 Reject large traffic

(1) For the products judged unqualified (rejected) by FQC, fill in the Notice of Nonconformity and submit it to the quality control supervisor for review.

(2) For the unqualified products found by the quality control supervisor after inspection, FQC shall affix the seal of "Unqualified" or "Rejected" on the label of its outer packaging and sign it.

(3) Save the Non-Conformity Notice, take FQC as the basis for reinspection, and transfer it to the manufacturing unit to arrange product re-flow (or inspection).

(4) The manufacturing unit shall arrange the re-flow operation of unqualified products according to the unqualified reasons, and carry out selection, processing and repair operations.

(5) After the heavy flow is completed, the manufacturing unit resubmits this batch of products, and FQC will conduct re-inspection.

(6) When re-submitting for inspection, the manufacturing unit shall fill in a notice of non-conformity, including the number of heavy flows, the number of defects found by heavy flows, improvement measures, etc., and submit it together with the inspection data.

3.4 Special Mining Warehousing

(1) The manufacturing or production management unit may apply for special procurement for products that are judged as unqualified (rejected) by FQC under the following circumstances:

(a) Minor defects have little effect on quality characteristics.

(b) The product is urgently needed for the next project or shipment.

(c) After simple selection or repair, it can be used for the next project.

(d) Other special circumstances.

(2) The manager of the Quality Control Department can maintain the unqualified judgment or change the special procurement (concession acceptance) after the audit.

(3) The products after special mining shall be put into storage according to the qualified product process, but FQC shall indicate the special mining and the reasons for the special mining on the label.

(4) Follow-up treatment methods for special collected materials:

(1) Concession to accept its use.

(b) Use after selection.

(c) Use after processing and repair.

Step 4 seize

[Attachment ]HA04- 1 Incoming Inspection Record Form

[Attachment ]HA04-2 Final Inspection Daily