Inspection Protocol Validation for a Medical Device Customer

A

aklug

#1
We are doing a validation for a medical device customer we need to send the protocol out for inspection... I am not comfortable with this as I believe the validation inspection should be done on our own equipment to keep with the nature and intent of the validation process. However, I am not the only person making this decision.

Can someone please tell me if subcontracting the validation inspection to a third party is acceptable? (point: I was not told if this was discussed with the customer prior, our approved protocol did not list our equipment specifically and the subcontractor will be using the type of equipment specified in the protocol)

Thank you for all your help.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
A quick "Bump". My Thanks in advance to anyone who can help with this one.
 
Thread starter Similar threads Forum Replies Date
Y What are different Special Inspection Level 1-4 and General spesification 1-3 ? AQL - Acceptable Quality Level 0
J Mechanical inspection techniques of close tolerance parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
B GM GP-12 Exit Criteria - Additional Safe Launch Inspection - (Also see GM1927-28 ) Customer and Company Specific Requirements 2
S Process Inspection -Sub assembly process inspection sheet Lean in Manufacturing and Service Industries 3
C OEE and In-process Inspection Manufacturing and Related Processes 2
R AS9100 - 8.4.2 - Receiving Inspection Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
I Mother bobbin final inspection criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Marc Visual Inspection - Color Vision Coffee Break and Water Cooler Discussions 15
G Inspection Logs - Asked to remove an Inspection Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Skooma Receiving Inspection - Boss trying to save money AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
T Sample of 1st Article Inspection Report wanted APQP and PPAP 3
T Nonconforming product at customer detected by a routine inspection by field service Nonconformance and Corrective Action 9
A Definition of customer in ITP (Inspection & Test Plan) Contract Review Process 3
T Correct MSA study for an automated camera system which makes attribute inspection Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A DCMA inspection for a drop-shipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S QUALITY OBJECTIVEs for third party garments factory inspection ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Lean and Elimination of QC Inspection Points in a New factory Lean in Manufacturing and Service Industries 9
F FDA-registration and inspection cost 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
I Receiving Inspection Requirement in IATF IATF 16949 - Automotive Quality Systems Standard 3
R Supplier related drawings and verification of process requirements - Source Inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D AS9100 Inspection records - Is there a requirement to have gauge ID and calibration status AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Good Acceptance Activity/Inspection flowchart for reference - Wanted Please Process Maps, Process Mapping and Turtle Diagrams 2
K Inspection Certificate EN 10204 2.1 - Distribution company Other ISO and International Standards and European Regulations 4
S Improving Quality inspection gate in one piece flow manufacturing process Manufacturing and Related Processes 0
M Loss of a Quality Record - FDA Inspection Records and Data - Quality, Legal and Other Evidence 4
S Need Assistance in Visual Inspection - Tiny electronic components AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S. Moore Is an Annual Layout Inspection the same as an Annual Re-validation? Internal Auditing 1
D Incoming (Receiving) Inspection - General form for incoming part inspection Document Control Systems, Procedures, Forms and Templates 17
K First Article Inspection (FAI) - Equipment used - Dimensions vs. Go/No-Go ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
S Inspection/sampling economics Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
C Is a First Article Inspection (FAI) Procedure required by ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
T EN 10204 3.1 Inspection Certificate - Machine Shop Various Other Specifications, Standards, and related Requirements 4
A Doubt on multiple inspection carrying out for same balloon number during Stage Inspection and Final Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M 3rd Party Sorting and Inspection Company Certification Service Industry Specific Topics 4
D FDA QSR task checklist based on inspection citations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
John Predmore What size pinhole can be reliably detected using visual inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
F Holes position inspection - Calculation of centre distance and plug sizes of a gauge Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
V Inspection with 3D Scanning - Reference Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
L Inspection Plan for Microscope Objective Lens Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
N Process Flow diagram steps for inspection and packaging APQP and PPAP 4
S Poka Yoke Inspection Retaining Ring (C-Clip) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J Recommendations on Inspection/SPC Software Statistical Analysis Tools, Techniques and SPC 4
M FAI AS9102 - What does a First Article Inspection cover? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
C AS9100, Clause 8.5.1.3 - First Article Inspection Costs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
V Receiving Inspection AQL - Am I allowed to just pick a AQL? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
U Whether First Article Inspection Report- FAI is mandatory for regular Human Factors and Ergonomics in Engineering 4
Ron Rompen GR&R on Automated Inspection Cell Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
N ISO 17020 Inspection Bodies - NDE as part of manufacture? Other ISO and International Standards and European Regulations 1

Similar threads

Top Bottom