Anlai Company Internal Use: The Clean room products of monitoring and measuring control procedures

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

Company official website: www.cleanroomffu.com

Product Cataloge tell you What are we selling:

Product Cataloge tell you What are we selling:

Air Purify equipment                    Consumable For clean rooom

1400 Air Shower                     Anti-static bag,& Polyethylene Series

1590 Air Shower                     ESD Chair Series

Automatic Air Shower                 Gloves & Finger Cots Series

Patent Air Shower Series               Mat&Wrist Strap Series

Surrounded high efficiency Air shower    Clean room Wipe Series

Pass Box                           Clean room clothes Series

Pass Box with Air Shower              Sticky Mat Series

Fan Filter Unit(FFU)                                                    

Level Cean Bench                    Related knowledge of the purify equipment

Vertical Clean Bench                 Basic knowledge of the air shower

Clean Bench with curtain             Food micro-pollution control by air shower

Hand Cleaner&Drier                The operation of Pass box& Air shower

Self-purification Equipment           Feature of the New fresh air Cabinet

Clean shed                         Feature of the Self-purification Equipment

The HEPA Unit                     Caution about use the Electronic Pass box&pass box

New Fresh Air Cabinet

Pharmaceutical Nagetive Weighing booth

HVAC Ventilation System Air filters

Mini-Pleated HEPA filter

HEPA filter with clapboard

ULPA filter

High-heat resistance HEPA filter

High-humidity HEPA filter

V bank HEPA filter

Pocket filter

V cell medium filter with plastic frame

Tank-style HEPA filter

Hooded HEPA filter

Pleated Prefilter with cardboard frame

Primary air filter with metal frame

Laboratory Furniture Series

Lab central bench

Island bench

Side-wall bench

File cabinet

Fume hood

All kinds cabinet

Source from: www.cleanroomffu.com

Congratulations! Anlai had signed a contract for large quantity of HEPA filter Box

UCustomer: Pechiney Group was founded in 1855 in France, the early days of a chemical plant, and later the development of aluminum products.

Ordered: 650pcs HEPA filters box

With below size: 1260*680*380mm HEPA filter box,

H14 Mini-pleated HEPA fiter: 1220*610*96mm,3000m3/h

Epoxy powder coated steel made HEPA filter box

With air flow control valve.

Qty: 300pcs

680*680*380mm HEPA filter box,

H14 Mini-pleated HEPA fiter: 610*610*69mm,1000m3/h

Epoxy powder coated steel made HEPA filter box

With air flow control valve.

Qty: 200pcs

554*554*380mm HEPA filter box,

H14 Mini-pleated HEPA fiter: 484*484*69mm,500m3/h

Epoxy powder coated steel made HEPA filter box

With air flow control valve.

Qty: 150pcs

Contract sign date: 17th,May,2014

300pcs HEPA filter box is already out:

Thanks for you support, Pechiney

We will continue our best service and quality products to you.

Shared by: Ms Vanessa Wang,skype: wangvanlu

Download newest brochures of AL 1400 AIr Shower Room

Download newest brochures of AL 1400 AIr Shower Room
Clidk on our website: www.cleanroomffu.com
Or contact with us at wangvanlu@gmail.com for easy get

Download Newest Catalogue of Anlai FFU Brochure

Download Newest Catalogue of Anlai FFU Brochure here
Click on our website: www.cleanroomffu.com
Or contact at wangvanlu@gmail.com for it

FFU use Manual

Specification

           Fan Filter Unit

1. Characteristic and use of the production

The Fan Filter Unit (FFU) is very universal purification equipment, normally installing on the every kind of frame, and it can form a highly clean environment for working. It has good effects on improving the clean-room’s condition, the quality of the production and the proportion of the finished product. The Workstation can widely use in every kinds of industry department and science lab, such as electron, national defense, exact instrument, pharmacy, agriculture and biology.

2. Parameter specification

Specification

Parameter             Model No.	AL-FFU1175
Standard Dimension	1175*575*370mm
Air Flow	1000-1100 m3/hr
Average of Air Speed	0.45m/s(0~0.8m/s)
Efficiency of Filter	99.99%
Noise	≤65dB
Rating Power	160 W
Power Supply	220V
Weight	31kg
Dimension for Hepa Filter	1170*570*69mm

3. The structure’s characteristic and element

    1. The structure’s characteristic

As the sketch map, the Flow Workstation makes up of cabinet, centrifugal fan, HEPA filter and operational on-off. The cabinet material use cold board plastic coated. The clean cells use the wind system that can change wind power. Through this process of changing, the average wind speed in the clean working area will keep in a rated range (0.3~0.45m/s). This can prolong the using time of air filter.

2. The element of working

The airs go through the pre filter, then into the pressure cabin by centrifugal fan, and go through the hepa filter at last. At this time, the clean air could come out and flow to the working area. The pressure in the working area is not same, so this can prevent the dust from outside. In order to enlarge the area of purification, we’d better use a dispersing component at air exit.

The Sketch Map of the Workstation

1         Sliding Handle

2         Pre-filter       

3         Adjustable Component

4         Fan

                5  Hepa Filter

4. Adjust installation

1.      You’d better put this production in the highly rate clean environment, at least 100 thousand rate.

2.      The place you install it, should be away from the dust and the hypocenter.

3.      As the map, the FFU should be installed from outside purification area, and be rooted by angle iron.

4.      If you change the pre filter and high filter, you should do it according to this step: 1> the pre filter just need carry up it, then changes a new one.2> the hepa filter, you need open the cover board on the back, and then change it.

5. The operation of using

1.      In order to ensure the purification in clean area, open the power for 15 minutes before using.

2.      If you don’t use for a long time, please pull out the power pin. And before you stop using, you need clean it with the cleaner and some other tools that can’t produce fiber. If you use it again, do this in the same way.

3.      Do not have boil action in the purification area.

4.      According to your need, ensure the times of change the air.

5.      According to your need, adjust the fan’s rate.

6.      Do not put the sundries outside the pre-filter, in that case, it will reduce the wind and the ability of purification.

6. The analyzing and removing to troubles

Troubles	Reason	Solving
The average wind speed is under or up the Wind Rating	The fan ‘s pressure is too low or too high	Adjust the switch of the fan’s speed
The wind speed is slow although the switch has changed into the highest.	1.        Too much dust in Pre-filter 2.        The HEPA filter is disabled	1.      Clean or change a new pre-filter 2.      Change a new HEPA filter
The fan isn’t running	Power line can’t use	Examine the power line

7.     Maintaining of FFU

1.      According to the clean rate in environment, you need to change the air filter timely. (usually 1~6 months)

2.      When you change the pre-filter or HEPA filter, please stop the FFU first.

3.      Remarks in changing HEPA filter:

1)      Please be carful in changing the HEPA filter, in order to make sure the filter is whole.

2)      When changing a new HEPA filter, open the cover board first, takes off the old one and then fit on the new HEPA filter.

8. Transporting and storing

   This purification cell could be transported by normal vehicle, but in this process, make sure it’s water-proof.

   This purification cell should be stored in the house that temperature is between -10℃~ +40℃;the relative humidity should be lower than 80% and without acid and alkali corrosive gas.

   The storing time limit can exceed 180 days in the state of having been packed.

9. Examine

1.      When you open the box, please be careful for fear damage the purification cell.

2.      When you open the box, please check it whether it is your order production. If you have any question, please contact me in a week.

3.      Please pay attention to following circumstances:

1)      Do not operate the power switch in a short time again and again.

2)      This production can not have guard against riot ability, so do not operate in the circumstance of flammability and easy-blast.

3)      Please do not touch the element in the production. If you really need, please cut off the power first.

4)      Strictly prohibit refit the machine, or it will result in getting an electric shock or fire.

5)      When you need to examine the machine, please cut off power.

6)      Do not put heavy thing on the power line, or else it will be broken to get an electric shock or fire.

7)      When you change a new fuse, please make sure its capacitance is in the rated lost.

8)      If you do not use for a long time, please pull out the BNC connector plugs.

9)      If there is some special things happened, please stops using and connected our company.

10)  Please connect the power line with a natural BNC connector jack.

10. Attached Drawing

Equipment warranty card

             

Product		Period of validity
Model №
Producing date

The follow the table be wrote by the retailer.

Customers name		Contact №
Address		Postcode
Purchase date

Retailer (with stamp)		Guangzhou Anlai Cleantech Co., Ltd.
Contact name		Telephone	86 138 26021570

Anlai Cleantech Co., Ltd. (Stamp)

编  号	ALWV110810

                  

                           

    检  验  报  告

        TEST REPORT

产品名称：     Fan Filter Unit

NAME OF SAMPLE

型号规格：1175*575*290mm

TRADE MARK & TYPE

              

Product name			Fan filter unit		Measurement		1175*575*290mm
Inspection sort			Factory inspection
Inspection items			(1)HEPA filter
			(2)Technology terms
Test  Results
N0.	Test Items			Technology Requirement		Test Result			Result
1	Appearance			No scar, no uneven and uniformity of spray-paint		pass
2	Size			Measurement base on draft		pass
3	Efficiency			Filter efficiency 99.99%@0.3um		pass
4	Air flow			1000~1100m3/h		pass
6	Noise (test away from 1m)			＜65db		pass
7	Air velocity of nozzles (m/s)			0.3-0.45m/s		pass
Result
Inspector						Date

     

Guangzhou RKS Airclean Equipment Manufacturing Co., Ltd.