The Clean room products of monitoring and measuring control procedures
1 objective
Monitoring and measuring for all kinds
of the characteristics of the product，Ensure that all of products accord with the quality requirements of the provisions,
and verify delivery of products to satisfy customer's requirements
2 Scope of
application
The procedures are suitable for
all kinds of products(including raw material、purchased part、cooperation part、semi-finished products、finished product)characters testing、verifying and monitoring.
3 Terms Glossary
3.1Test：Through the observation and judgment，appropriate according to the measuring, test of compliance
evaluation
3.2 verify：Through the provision of objective
evidence，to meet the requirements has been
recognized
3.3 Incoming quality control：For the different kinds of products which enter into
the company(including spot purchase, outward processing come back and customer
samples) should proceed quality features a group of operation compliance
validation
3.4 In process quality control：For the all products which in production should
measuring and test and verify, then determine whether their compliance with the quality requirements.
3.5 First item inspection： The products for try production should measure or verification
before the commercial
production，confirm the quality meets the
requirements than allow into mass production.
3.6 Independent
inspection：Product quality testing or validation activity are proceed by producer
themselves.
3.7 Crosschecking: After working
process to process before （or First-line managers to producers）Product quality
supervision or validation activity
3.8 Final inspection：s professional
staff to already complete machining process of the corresponding
semi-finished products and finished goods before
storing in packaging or deliver the customer before
and after the quality inspection or
before validation activity。
4 Responsibility
4.1 The manufacturing quality control class leader, supervision and
management of all kinds product quality inspection activities, inspection report for examination and approval，tracking and validation nonconforming
product processing mode，Participate in the
implementation of and review the corrective
action and preventive measures，suggestion for outstanding achievements inspection personnel or dereliction give rewards and punishments, etc；Responsible for the
standard that presses a regulation and implementation method, process
inspection incoming inspection and final inspection, product audit and full
size inspection activities，truthfully record test process and result.
4.2 General
manager/Manufacturing minister: Responsible for
special products (Project) emergency release approval。
4.3 The direct production (operating) workers
from each manufacturing department
should be responsible for the
first inspection, self-check and mutual inspection；Each basic management personnel should be responsible for confirmation of first inspection and mutual
inspection.
5 Working procedure
5.1 R & D department in conjunction with the manufacturing
department quality control , national and international standards or customer
requirements combined with the
practical condition to make the products’ quality inspection standard ,test or
validation methods , determination criterion or the acceptance criteria; All
kinds of inspection activities should be carried out strictly according to the
regulation (required), and to determine correctly if they are qualified or not
.
5.1.1 When the incoming
products (including the purchasing products, customers with property, hair
outside (external) processing returns product) arrive to the factory, the
relevant personnel(purchasing department/warehouse controller) notify the
incoming inspection personnel from the quality control department (r&d
technology related personnel) to the site, and then to record the inspection
results faithfully and to determine if they are qualified or not according to
the raw material/outsourcing parts inspection standards " and " the
sampling inspection rules "relevant regulations and on the basis of the
quality of the product of the corresponding standard (requirements) and
inspection or validation methods for inspection.
5.1.1.1 All kinds of products belong to the range of verification should test and collect as well as keep the
suppliers’ related quality report (quality certificate) for future reference
according to the corresponding verification method verification.
5.1.1.2 After the examination or validation for qualified incoming judge
products, the inspection personnel should stamp "qualified" seal on
the product (tag) or provide corresponding proof (report), and check the
incoming number (or keeping/use)
by the warehouse (or keeping) personnel .
5.1.1.3 After the examination or verification of materials to be
determined as unqualified products, the inspection personnel should suspend
(paste) "unqualified" logo on the products, and inform the related
personnel (purchasing department/sales) to deal with them according to the “
nonconforming control procedures ".
5.1.1.4 If the product can't be
tested on time or can’t wait for the inspection results, then it should be put
forward an urgent production application by the manufacturing department and
deliver to the general manager or the manufacturing department minister for
approval. It can release until the striking logos are done, and notify the
process inspection personnel to strictly control the product’s quality. The
releasing time is limited by the test
time required. When the test result is “unqualified”, the quality control
department shall be notified immediately to stop the production, and retrieve the
already released products as well as completes the logo to deal with.
5.1.2 In the process of
production (processing)for all kinds of products shall be tested ,examined or
verified according to the corresponding workshop working instruction inspection
requirements, quality plan/control plans requirements, related inspection
standard and inspection method.
5.1.2.1 When products are transferred into the continuous production, the
machine (process) operator should often self-check the necessary number
products, in order to verify the device, mould, product’s quality is stable or
not ; The First-line managers are responsible for sampling inspection &
validation .
5.1.3 The quality control department inspection personnel for each
process confirm the first results according to relevant products (process)
inspection standard and inspection method ,and do detection test according to
certain time interval extraction, filling out inspection records (report), and
reporting the qualified problem, tracking validation processing results. When it is necessary, they have the right to
inform a moratorium on the production to
ensure the products can comply with the quality requirements.
5.1.4 If it has to
release the rejected products due to the production, the manufacture department
shall work together with the related r&d technicians to analyze and confirm
the final product quality defects effects and the waste correct prevention
capacity. Then the manufacture production scheduling researchers propose the
exception application to the general manager (or the manufacture department
minister) for approval. The inspection personnel should do some striking logo
for releasing, and notify the final inspection personnel to strictly test the
released products’ quality; Once the great influence wan found , it should
stopped the exception release, and retrieve the already released products as well as completes the logo to deal with.
5.1.5 For incoming
(including semi-finished products and finished products) or the products ready
to deliver to the customers , the quality control department finally inspection
personnel should determine if the products are qualified or not according to
the finished products inspection standards "& " the sampling
inspection rules "relevant regulations on the basis of the quality of the
product of the corresponding standard (requirements) and to test or check out
the methods for inspection as well as record the inspection results faithfully
.
5.1.5.1 Once the
products are tested to be qualified, the inspection personnel should stamp
"qualified" in the product labels (process card) .
5.1.5.2 When the
products are determined to be
substandard products by the test, the inspectors should hang or stick the mark on the product with “disqualification”, and
notify the relevant personnel to isolate the storage according to the <Nonconerrorforming product control procedure>to dispose,and follow the tracking validation
processing results.
5.1.6 Quality control department should arrange
officials to sample and audit all kinds of packaging products in proper
frequency to verify compliance with all specified requirements(such as product,
packaging, labeling, etc.);When customers have
requirements, they should test the full size and functional verification
in the frequency as customers’ requirements, the results are submitted for
customer review.
5.2 In order to prevent the misuse or the ship wrong goods, the right inspection marks should be choosen in
inspecting various products according to the actual situation. The inspection mark
including: inspection pending、qualified、mutatis mutandis、disqualification、judgment pending、dispose pending etc. Specific requirement according < Identification and traceability management approach> to carry
out.
5.3 Inspection records’ (report) fill in、approval 、dispose 、statistics、analysis and storage.
5.3.1 All kinds of
inspection personnel should according the rule or requirement to record
inspection process accurately and completely, the judge inspection results or
handle suggestions should be written neatly and kept the surface clean.
5.3.2 All kinds of
inspection personnel should according the rule or requirement to record
inspection process accurately and completely, the judge inspection results or
handle suggestions should be wrote neatly and kept the surface clean.
5.3.3 Inspection records (report) should be hand in confirmation or for examination and approval step by step in
time, the “disqualification” in the record(report) should informrelevant
departments to deal with as < Unqualified control program> in time, the
related personnel of quality control department should be responsible for
tracking verification and reporting nonconforming product processing results.
5.3.4 Quality
records(report) should be collected regularly to the related statistical
analysis personnel of quality control department, and choose appropriate
statistical analysis technology statistical classification, draw figure,
analysis quality trend of change, find out the cause of the existing or
potential, plan to correct or preventive measures, and regularly or timely
report to the related management for decision-making reference.
5.3.5 Incoming
inspection statistical results should be submitted to general logistics
department purchasing group to review as a basis of qualified suppliers.
5.3.6 Quality control
department should assign part-time (or full-time) personnel to responsible for
the inspection record and relevant information of the collection、clear up、classification index, keeping
properly and use, specific requirements according to records control program
execution.
5.4 The quality inspection posts should choose the personnel who
have appropriated training and obtained necessary qualification. The
corresponding skills to ensure the competence. The training methods according
<Employee training management program>to execute.
5.4.1 The quality
control division chief should periodically organize assess on inspection
personnel’s professional ethics,the quality performance and competency-based.
The results need to be submitted to general logistics department human
administrative group to deposit in employees' personal files as the main basis
for choosing, promotion, raises and reward in the
future.
6. Related / supporting documents
6.1<The
control of nonconforming product>
6.2 <Providers
to develop and review management approach>
6.3<
Identification and traceability management approach>
6.4 <Control of
records procedure>
6.5 <Staff
training and management procedures>
6.6《Different kinds of products/
Operating standards and methods of inspectors》
6.7《Sampling inspection standards》
7、Quality records
7.1《Various types of product testing
records》 The serial number: AL/QER- Product
monitoring and measurement -01-A/0
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