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
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Do CTQs need to be equipment specific? FMEA and Control Plans 8
K Contract Manufacturer Do they need a complaint procedure? Medical Device and FDA Regulations and Standards News 8
K Screen printing ink and machine selection_ Need help Manufacturing and Related Processes 6
D Do employee training records need to be centralized? IATF 16949 - Automotive Quality Systems Standard 10
H Need of EU Representative Designation for Turkey? EU Medical Device Regulations 3
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
briteme4 AS9102 First Article Inspection - do I need a second reviewer and signer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Furnace repaired - Do I need a new initial TUS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
J Need a contract monitoring Tool General Information Resources 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
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 6
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

Similar threads

Top Bottom