- 博客(126)
- 收藏
- 关注
RSS订阅原创 黄石市MedAccred _AC8121电子电缆和线束组件的审核标准 （63）
30.5.9 C- Is there evidence that contact retention verification and / or testing is accomplished prior to addition of any restraining devices?YES/NO/NA30.6Connector Testing30.6.1 P- If required by the customer, is there a procedure for testing connector
2021-08-05 11:14:45
125
原创 武汉市MedAccred _AC8121电子电缆和线束组件的审核标准 （62）
30.4.1 P- Is there a procedure for the acceptance criteria for connector damage?YES/NO/NAAudit Note: Includes inspecting damage when deplugging terminals from connectors.30.4.2 C- Is there evidence that acceptance criteria for connector damage in accorda
2021-08-05 11:13:38
110
原创 重庆市MedAccred _AC8121电子电缆和线束组件的审核标准 （61）
30.3.22 C- Is the visual inspection criteria of adhesives used for sleeves and boots on connectors available and being performed in accordance with the procedure, including:Audit Note: Question NA applies when sleeves and boots do not have adhesives.30.3
2021-08-05 11:12:36
120
原创 天津市MedAccred _AC8121电子电缆和线束组件的审核标准 （60）
30.3.13 C- If required, are the requirements for the work life / pot life of the adhesive material used for connector sleeves and boots being met?YES/NO/NA30.3.14 C- If required, are the requirements for the mix ratios of the adhesive material used for co
2021-08-05 11:10:59
76
原创 信阳市MedAccred _AC8121电子电缆和线束组件的审核标准 （59）
30.3.5.1 P- Coverage?YES/NO/NA30.3.5.2 P- Adhesion?YES/NO/NA30.3.5.3 P- Bubbles?YES/NO/NA30.3.5.4 P- Cleanliness?YES/NO/NA30.3.5.5 P- Cure?YES/NO/NA30.3.5.6 P- Location?YES/NO/NA30.3.6 P- Is there a procedure to ensure connectors are not contaminated
2021-08-05 11:10:08
93
原创 许昌市MedAccred _AC8121电子电缆和线束组件的审核标准 （58）
30.3.3 P- When a conductive adhesive is required in the assembly process, does a procedure exist for testing that resulting conductive path is acceptable?YES/NO/NA30.3.4 P- Is there a procedure to define and control the adhesive bonding of sleeves and boo
2021-08-05 11:09:12
78
原创 南阳市MedAccred _AC8121电子电缆和线束组件的审核标准 （57）
30.2 Connector Strain Relief30.2.1 P- Is there a procedure for the installation of strain relief?YES/NO30.2.2P- Is there a procedure that defines and controls materials used to build up wire bundles for clamp fit and wire protection?YES/NO30.2.3 P- Is t
2021-08-05 11:08:23
69
原创 洛阳市MedAccred _AC8121电子电缆和线束组件的审核标准 （56）
29.21 C- If used, is each wire inspected for acceptability, when multiple wires are attached to a single terminal when manufacturing crimp splices?YES/NO/NA29.22 C- If used, does the Circular Mil Area (CMA) for wires in a crimp splice comply with the CMA
2021-08-05 11:07:06
81
原创 新乡市MedAccred _AC8121电子电缆和线束组件的审核标准 （55）
29.5 C- Are only authorized splices being performed in production?YES/NO29.6 C- Are personnel aware of the limitations on splicing for production?YES/NO29.7 C- Is there evidence of splicing performed in accordance with procedures / customer requirements?
2021-08-05 11:05:45
105
原创 焦作市MedAccred _AC8121电子电缆和线束组件的审核标准 （54）
28.ULTRASONIC WELDING SECTION NA28.1 P- Is there a procedure for ultrasonic welding?YES/NO28.2 P- If used, are the procedures for ultrasonic welding of splices linked to general ultrasonic welding requirements?YES/NO28.3 P- Is there a procedure for acce
2021-08-05 11:02:01
71
原创 淮南市MedAccred _AC8121电子电缆和线束组件的审核标准 （53）
27.INSULATION DISPLACEMENT CONNECTION (IDC) SECTION NA27.1 P- Is there a procedure that defines the IDC process ensuring process control of IDC parts that is compliant with the IPC/WHMA-A-620?YES/NO27.2 P- Is there a procedure restricting the rework of I
2021-08-04 14:58:02
83
原创 芜湖市MedAccred _AC8121电子电缆和线束组件的审核标准 （52）
26.31 C- If used, is there evidence for the control and proper use of semi- automatic crimping equipment, in accordance with the procedure?YES/NO26.32 C- If used, is there evidence for the control and proper use of manual crimping tools, in accordance wit
2021-08-04 14:56:08
81
原创 六安市MedAccred _AC8121电子电缆和线束组件的审核标准 （51）
26.21 C- Are crimping tools used in production in accordance with requirements in procedures?YES/NO26.22 C- If required, when changing settings on adjustable crimp tooling, is there a process step that requires testing samples to ensure correct crimping b
2021-08-04 14:55:07
77
原创 合肥市MedAccred _AC8121电子电缆和线束组件的审核标准 （50）
26.11 Audit Note: NA applies when there is no customer requirement to calculate circular mil area.YES/NO/NAAudit Note: NA applies when there is no customer requirement to calculate circular mil area.26.12 P- If required, is there a procedure to control m
2021-08-04 14:54:10
105
原创 赣州市MedAccred _AC8121电子电缆和线束组件的审核标准 （49）
CRIMPING SECTION NA26.1 P- Is there a procedure for crimping?YES/NO26.2 P- Are there procedures for wire positioning and placement into a terminal to be crimped?YES/NO26.3 P- If used, is there a procedure for validating and using crimp tooling other t.
2021-08-04 14:52:52
57
原创 宜春市MedAccred _AC8121电子电缆和线束组件的审核标准 （48）
25.24 C- Is the cleaning method being used and is the maximum time permitted between hand soldering and cleaning being observed, in accordance with procedures?YES/NO25.25 C- Are all drawings, written instructions, and product specific fixtures under confi
2021-08-04 14:51:49
93
原创 上饶市MedAccred _AC8121电子电缆和线束组件的审核标准 （47）
25.11 C- Is the setup of soldering equipment being carried out in accordance with procedures?YES/NO25.12 C- Is the procedure for soldering being followed?YES/NO25.13 C- Is the process that defines the acceptance criteria of soldered connections available
2021-08-04 14:50:46
91
原创 景德镇市MedAccred _AC8121电子电缆和线束组件的审核标准 （46）
25.3 P- Is there a procedure for control of soldering tools / equipment including:25.3.1 P- Selection and setup?YES/NO25.3.2 P- Maintenance and periodic verification, including soldering iron tips for temperature?YES/NO25.3.3 P- If required is the solde
2021-08-04 14:49:41
81
原创 南昌市MedAccred _AC8121电子电缆和线束组件的审核标准 （45）
24.WIRE TINNING SECTION NA24.1 P- Is there a procedure that defines the solder alloy and flux type to be used?YES/NOAudit Note: Solder and Flux are addressed in IPC/WHMA-A-620 para4.1.1.1 & 4.1.1.2, respectively.24.2P- Is there a procedure that def
2021-08-04 14:48:49
72
原创 江门市MedAccred _AC8121电子电缆和线束组件的审核标准 （44）
21.4 Thermal Wire Stripping SECTION NA21.4.1 P- Is there a procedure for the use of thermal wire stripping that includes tools, setup, control and inspection?YES/NO21.4.2 C- Is there evidence that preventative maintenance is being performed?YES/NO21.5 W
2021-08-04 14:47:30
91
原创 中山市MedAccred _AC8121电子电缆和线束组件的审核标准 （42）
20.8C- Is there evidence that time between assembly (e.g.: soldering) and cleaning has been limited to the maximum value specified in the procedure?YES/NO/NA20.9 C- Are the procedures being followed for the setup, operation and maintenance of all cleaning
2021-08-03 16:38:53
80
原创 佛山市MedAccred _AC8121电子电缆和线束组件的审核标准 （41）
19.17 C- During the rework process do the handling, storage and control of the assembly, components and materials meet the requirements of the applicable sections of this checklist?YES/NO19.18 C- If rework has been performed, is there evidence that cleani
2021-08-03 16:37:35
81
原创 惠州市MedAccred _AC8121电子电缆和线束组件的审核标准 （40）
19.8 C- If rework requires specific subsequent stages to be completed as detailed in the procedure, is there evidence that this is being performed?YES/NO/NA19.9 C- Are parts removed during rework prevented from being reused unless authorized in accordance
2021-08-03 16:34:51
97
原创 揭阳市MedAccred _AC8121电子电缆和线束组件的审核标准 （39）
19.2.1 P- Who performed the rework?YES/NO19.2.2 P- Reverification of product following rework?YES/NO19.2.3 P- Description of rework performed? YES/NO19.2.4 P- Location of rework?YES/NO19.2.5 P- Number of reworks per location if required?YES/NO19.3 P-
2021-08-03 16:31:49
73
原创 梅州市MedAccred _AC8121电子电缆和线束组件的审核标准 （38）
18.8C- Is packaging of components in accordance with the procedure?YES/NO18.9 C- Are all age sensitive materials in storage / use within specified shelf- life?YES/NO18.10C- Is the procedure for the control of storage environments for temperature and humi
2021-08-03 16:28:57
97
原创 阳江市MedAccred _AC8121电子电缆和线束组件的审核标准 （37）
17.RECEIPT, INSPECTION AND CONTROL OF INCOMING MATERIAL17.1 P- Are there procedures that define traceability and configuration control in accordance with customer requirements?YES/NO17.2 P- Are there procedures that define age sensitive material control?
2021-08-03 16:26:14
112
原创 云浮市MedAccred _AC8121电子电缆和线束组件的审核标准 （36）
VISUAL ACUITY15.1 P- Is there a procedure which addresses the capability needs and controls of visual perception (including test frequency) for assembly and inspection personnel to include color distinction and near sight acuity to a defined national/in.
2021-08-03 16:24:21
58
原创 惠州市MedAccred _AC8121电子电缆和线束组件的审核标准 （35）
14.3 P- Does the documented qualification program for operators and inspectors include periodic training and certification at defined frequencies to ensure that operators and inspectors maintain qualification?YES/NO14.4 P- If customer specific requirement
2021-08-03 16:22:27
83
原创 汕头市MedAccred _AC8121电子电缆和线束组件的审核标准 （34）
13.27 C- When major elements of the proven materials, processes or equipment are initially launched or changed, are the following complete:13.27.1 C- Verification/validation records of the change? YES/NO13.27.2 C- Training records indicating operators ha
2021-08-03 16:21:11
90
原创 广西省MedAccred _AC8121电子电缆和线束组件的审核标准 （33）
programs, and if required, the translation of customer Part Number to shop floor Part Number?YES/NO13.22 C- Do operators demon13.21 C- Is there objective evidence that correct component part revision levels are used in shop floor instructions, Bill of Mat
2021-08-03 16:18:03
74
原创 湖南省MedAccred _AC8121电子电缆和线束组件的审核标准 （32）
13.10 C- Are documents, including customer-supplied documents, readily retrievable on site and at the latest revision?YES/NO13.11 C- Is there evidence that a formal First Article Inspection is conducted for new product introductions and engineering change
2021-08-02 11:05:47
71
原创 西藏MedAccred _AC8121电子电缆和线束组件的审核标准 （31）
13.2 P- Is there a procedure that requires all processes, materials and equipment to be under formal change control and requires any initial launch and changes to go through a qualification process?YES/NO13.3 P- If required by customer, for new product in
2021-08-02 11:01:44
67
原创 江西省MedAccred _AC8121电子电缆和线束组件的审核标准 （30）
12.PURCHASING AND AUTHENTIC COMPONENT ASSURANCE12.1 P- Is there a procedure that defines controls for ensuring procurement of authentic material from original manufacturers or their authorized distributors, supplier-approved independent distributors, or c
2021-08-02 11:00:45
72
原创 云南省MedAccred _AC8121电子电缆和线束组件的审核标准 （29）
9.8 C- If external calibration sources are used, is the source an approved supplier?YES/NO10.PREVENTATIVE MAINTENANCE10.1 P- Is there a procedure to ensure periodic maintenance of all required production and testing equipment? YES/NO10.2 P- Is there a
2021-08-02 10:59:12
64
原创 四川省MedAccred —AC8121电子电缆和线束组件的审核标准 （28）
8.TOOLS AND EQUIPMENT8.1 P- Is there a procedure for the verification of tooling prior to use?YES/NOAudit Note: Tooling to be verified should include crimp tools (first piece / last piece), torque tools, soldering irons, etc.8.2 C- Is there evidence tha
2021-07-31 10:32:03
49
原创 黑龙江省MedAccred —AC8121电子电缆和线束组件的审核标准 （27）
7.12 C- Does the supplier assure that visitors entering the EPA are using the stated ESD protection methods? YES/NO7.13 C- Are the visitors’ ESD protection methods tested and recorded as per the procedure? YES/NO/NAAudit Note: NA when no equipment is pro
2021-07-31 10:30:57
78
原创 吉林省MedAccred —AC8121电子电缆和线束组件的审核标准 （26）
7.2 P- Is there a preventive maintenance plan which includes cleaning, calibration, verification method, audit frequency, coverage and depth of audit of all aspects of the protection methods declared in the procedure? YES/NO7.3 P- Is there a procedure th
2021-07-31 10:29:59
107
原创 辽宁省MedAccred —AC8121电子电缆和线束组件的审核标准 （25）
6.3.10 C- For process and testing steps performed during rework?YES/NO6.3.11 C- For process steps performed by an outside source? YES/NO/NA6.3.12 C- For work in process? YES/NO7.ELECTROSTATIC DISCHARGE (ESD) MANAGEMENT SECTION NA7.1 P- Are there proced
2021-07-31 10:23:31
72
原创 河北省MedAccred —AC8121电子电缆和线束组件的审核标准 （24）
6.MEDICAL RECORD KEEPING6.1 Device Master Record (DMR)6.1.1 P- Is there an internal procedure defining DMR consistent with requirements such as 21 CFR part 820.181, 93/42/EEC or regional/ country regulatory requirements? YES/NO6.1.2 C- Is the supplier c
2021-07-30 10:55:27
72
原创 内蒙古省MedAccred —AC8121电子电缆和线束组件的审核标准 （23）
5.2.4 © Is there evidence that initial process validation is being done per the procedure? YES/NO5.2.5 © Is there evidence that acceptance criteria was established prior to execution of the validation?YES/NO5.2.6 © Is there evidence of a sampling plan th
2021-07-30 10:52:29
54
空空如也
空空如也
TA创建的收藏夹 TA关注的收藏夹
TA关注的人