SBS - The best value in QMS software

Need Assistance in Visual Inspection - Tiny electronic components

S

Sharon L

#1
Internal auditor wrote me up for not having a sampling plan on tiny electronic components. I am a distributor of electronic components that sell product purchased from OEMs and CMs as excess materials.

1> Is there any requirement for visual inspection of electronic components? Such as do the components need to be removed from tapes and tubes to be inspected?

2> Is there a standard for magnification of 10X or more?

Thank you!
 
Elsmar Forum Sponsor
S

Sharon L

#3
This was for my AS9120 internal audit. They didn't reference where the requirement was in the standard.
  • There is no documented sampling plan that is based on quantities of parts ordered. Presently the sampling is performed by taking 1 sample per Date Code.
 
Last edited by a moderator:

Jim Wynne

Staff member
Admin
#5
This was for my AS9120 internal audit. They did reference where the requirement was in the standard.
  • There is no documented sampling plan that is based on quantities of parts ordered. Presently the sampling is performed by taking 1 sample per Date Code.
Your quotation of the finding doesn't include a reference to the standard or your internal requirements.
 

Eredhel

Quality Manager
#9
I would ask the internal auditor for a specific callout for the NC before doing anything else. Was this a company auditor or a 3rd party one?
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#10
The point here Sharon, is that if there is no requirement (internally or standard) there is not a NC. If it is anything, presuming that there is no requirements, it would be an OFI instead of a NC. In my opinion.
 
Thread starter Similar threads Forum Replies Date
S NADCAP approval for Conventional Machining and Chemical processes - need assistance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
C Need assistance with ISO 9001 Certification Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
E Need assistance with Complaint Management Database Customer Complaints 3
B Need Assistance for Implementing ISO 9001 in our organisation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Need assistance on how to generate Change Notices for Vendors and tracking APQP and PPAP 0
O Need Assistance in understanding AS9100 Rev.B AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
S Need assistance in GD&T and Design of checking fixtures, gauges Design and Development of Products and Processes 3
K Need Assistance Interpreting Gage R&R Data - Stylus profilometer Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Ed Panek Immediate need for 80601-2-56 Consulting expert. PM me for details Career and Occupation Discussions 0
Tagin You're Gonna Need a Bigger Root Cause Coffee Break and Water Cooler Discussions 12
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 2
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
I Do I need to sign off my annual audit calendar? Internal Auditing 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
K Do I need a "State of the art" plan? CE Marking (Conformité Européene) / CB Scheme 1
S Need advice for schooling Quality Manager and Management Related Issues 5
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
H Need MSA 4th ed. compliant attribute MSA template General Measurement Device and Calibration Topics 4
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Countries with no need for FSC (Free sales certificate) Other Medical Device Regulations World-Wide 0
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
N IPC-A-630 - Is this free or do i really need to pay for it? Manufacturing and Related Processes 4
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
silentmonkey How to decide what characteristics need to be verified during incoming inspection? ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Proof of Concept Studies - Do we need to comply with SAE reporting? Medical Device and FDA Regulations and Standards News 3
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
W Need for current design or process control FMEA and Control Plans 2

Similar threads

Top Bottom