SBS - The best value in QMS software

First Article Report Requirements for 30 Parts

Wes Bucey

Prophet of Profit
#11
No, machines were not left in original setup. I asume that CNC program can run like CMM if using same features for alignment. I am not very familiar with the CNC's. But I do measure first part of each run, full dimensional layout. I am not sure if that would be enough.
Sources of variation include tooling and possibly different material lots. My experience with different lots of the same material was there was sometimes a difference in machinability and often a difference based on tooling wear.

Perhaps your experience is different - how do you know unless you inspect?
 
Elsmar Forum Sponsor

Brizilla

Quite Involved in Discussions
#12
Sources of variation include tooling and possibly different material lots. My experience with different lots of the same material was there was sometimes a difference in machinability and often a difference based on tooling wear.

Perhaps your experience is different - how do you know unless you inspect?
Tooling wear, variations in material, spindle alignment, tooling tightness, coolant, chuck wear, whether it was the same (as competent ) set-up guy, operator experience and so on. There are a ton of variables beyond the program. About the only similarities between a CNC and a CMM is the both use programs to redundant operation.
 
Thread starter Similar threads Forum Replies Date
K Clinical Evaluation Report Article Summary Requirements EU Medical Device Regulations 5
T Sample of 1st Article Inspection Report wanted APQP and PPAP 3
U Whether First Article Inspection Report- FAI is mandatory for regular Human Factors and Ergonomics in Engineering 4
R FAI (First Article Inspection) Report Number Method AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Q AS9100 and FAIR (First Article Inspection Report) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Measure "TYP" dimensions on a first article inspection (FAI) report? ISO 13485:2016 - Medical Device Quality Management Systems 10
A FAIR (First Article Inspection Report) for Engineering Services Organisations needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
C First Article Inspections - 'how to measure' General Measurement Device and Calibration Topics 11
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
F Component maintenance qualification - Regulation (EU) No 1321/2014 Article 5 EASA and JAA Aviation Standards and Requirements 6
M Vigilance - incident found in an article EU Medical Device Regulations 3
dgrainger Informational MHRA guidance on CE UKNI - Article 5.5 - 2021-02 EU Medical Device Regulations 0
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
M MDR Article 22 Interpretation EU Medical Device Regulations 3
L EU MDR Article 86 PSUR EU Medical Device Regulations 1
K Article 18: Implant Card and information to be communicated. EU Medical Device Regulations 5
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
S Article 22 Procedure Pack Labelling EU Medical Device Regulations 4
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
S Translational Requirements - Article 120 EU Medical Device Regulations 5
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
K Expected lifetime of the device-Article 18 EU Medical Device Regulations 4
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 8
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 8
T Implant Card - Article 18.1(a) and MDCG 2019-8 clarification EU Medical Device Regulations 3
P Economic operator responsibilities - when the Importer is also Distributor - Article 13 EU Medical Device Regulations 1
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
K Article 18 in the Implant Card - Expected lifetime of the device EU Medical Device Regulations 3
S Article 61 - MDR Clinical Investigation Requirement EU Medical Device Regulations 5
C Article 16 MDR - Medicine packaged together with Medical Device EU Medical Device Regulations 0
F MDR system/procedurepack (article 22) with device acc. to MDD and MDR CE Marking (Conformité Européene) / CB Scheme 2
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 8
R MDR Article 22: Systems and procedure packs Other Medical Device Regulations World-Wide 12
T EU MDR Article 61- Clinical Evaluation EU Medical Device Regulations 2
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
Sidney Vianna Interesting Discussion Interesting article form the UNIDO Magazine - CSR: a wolf in sheep’s clothing? Sustainability, Green Initiatives and Ecology 16
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
M Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re Medical Device and FDA Regulations and Standards News 7
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
A Interpretation of Article 16 (2b) - Packaging, samples and Certificate EU Medical Device Regulations 10
E MDR Article 117 / Impact to New Marketing Authorization Applications Other Medical Device Regulations World-Wide 1
G First Article Submission (Destruction of parts) APQP and PPAP 2
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
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 MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
T MDR article 22 - System of 2 CE products and validation / usability? EU Medical Device Regulations 10

Similar threads

Top Bottom