Do I need to add everything on print to control plan?

V

vardar3

#1
We do metal stamping. Part prints have lots of detail, all of which are not checked by the gage.

In most cases, the gage is all we use to check the part, but in some cases we use CMM or indicators.

If there is a print characteristic, say a radius or flatness that is not being checked, do I have to add it to the control plan?

Am I in violation for not having a flatness on the control plan, which is on the print, but not being checked?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
H Need to add a concentrate (only) to an already approved IMDS Submission RoHS, REACH, ELV, IMDS and Restricted Substances 5
T Updating to ISO 9001:2008 - I need to add section 7.3 Design and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
S Need to change multi-site TS 16949 certification to add another company Registrars and Notified Bodies 4
T I need an add-in for excel that I can use for SPC (Statistical Process Control) Excel .xls Spreadsheet Templates and Tools 4
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 2
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 0
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
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
S Need help with analysing a survey on minitab Using Minitab Software 1
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
G Need resources / tutorials about OPS (Operation) for ISO IT (Information Technology) Service Management 8
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
G Do we need to QA cert? We only plan to supply reagents Medical Device and FDA Regulations and Standards News 3
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
R Evaluating the need for preventive action Preventive Action and Continuous Improvement 3
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
8 Need Help - Runout - Function Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
F How many signatures do we need on calibration certificates? ISO 17025 related Discussions 8
B We need a QMS: file-based templates or software Other Medical Device Related Standards 23
M AQL table - I need to sample 1250pcs AQL - Acceptable Quality Level 3
atitheya Need of conducting medical trials in European Union EU Medical Device Regulations 2
L Gage R&R studies for identical Devices - Need to confirm the requirement to perform them Reliability Analysis - Predictions, Testing and Standards 2
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1
I IATF16949 Audit Preparation, Need "searchable" ANPQP 3.1 or latest IATF 16949 - Automotive Quality Systems Standard 1
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
S New to FAIR, need help in filling it out AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
S ISO 9001:2015 & ISO 14001:2015 - I need a format for Design & Development planning ISO 14001:2015 Specific Discussions 2
M Informational Some things the EU MDR 2017/745 does not tell you, but you may need to know to comply with it effectively – Part 1 Medical Device and FDA Regulations and Standards News 0
S NADCAP approval for Conventional Machining and Chemical processes - need assistance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
S Do we need to validate Software used in Drug discovery and development process? Qualification and Validation (including 21 CFR Part 11) 2
W Tying the need for Demand Planning to a section of AS9100/9110 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4

Similar threads

Top Bottom