tangxinwei2008(威望:3)
(广东 深圳)
在校学生 工程师
- 十年SQE, 现转岗NPI QE
赞同来自:
仅供参考：
－－－－－－－－－－－－－－－－－－－－
AUDIT AGENDA
Key Audit Points:
Process control critical areas including:
a. Equipment parameters control
b. Control plan
c. Inspection process
d. Silkscreen marking process
e. Product packaging design and quality control
RSS Feed
2 个回复
tangxinwei2008 (威望:3) (广东 深圳) 在校学生 工程师 - 十年SQE, 现转岗NPI QE
赞同来自:
－－－－－－－－－－－－－－－－－－－－
AUDIT AGENDA
Process control critical areas including:
a. Equipment parameters control
b. Control plan
c. Inspection process
d. Silkscreen marking process
e. Product packaging design and quality control
Technical capability validation (tool/mold design)
Outgoing inspection system
- Inspection Report
- CoC
XXX Medical cover mechanical drawing requirements
Visual criteria correlation
Signed GAQ
- PRODUCT AUDIT
Visual CriteriaDimensions (tolerances)
Material Specifications
Defined IMI Requirement
- PROCESS AUDIT
Process Control PlanEquipment Parameters
Technology
其他：
AUDIT EXPECTATIONS
Assess system and process capability to meet XXXgeneral requirements
Validate technical capability to consistently meet XXXX Medical product requirements
Establish supplier/XXX partnership