Is it a requirement for run charts to have inspection data or can it have just a pass/fail check mark

Hybrid

Involved In Discussions
For example: Run chart says "BODY LENGTH = .060 ± .005" I measure the body length and get ".062"

Is it a ISO requirement to write my result or can i just put "pass"

ISO 9001:2015 to be exact
 

Bev D

Heretical Statistician
Leader
Super Moderator
Are you taking about a form where you right down the result or are you taking about a plot of the data over time?

ISO doesn’t cover run charts.
you can record results in any way you want.

HOWEVER: there is far more information when you record or plot the actual value.
 

seeva

Registered
Are you taking about a form where you right down the result or are you taking about a plot of the data over time?

ISO doesn’t cover run charts.
you can record results in any way you want.

However, for automotive supplier's ,this is far more informative when you record or plot the actual value.
I personally feel the objective to perform the measurement and clearly writing down the actual measurement , for the purpose of customer quality incidence / return, this indicators with actual data provide valuable info during investigation . Depending on the type of measurement taken, it can also add value to use a chart like X Bar R , to monitor the trend of the process ,
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
Generally ISO has been very general about trending. Thou shalt do it. In some cases, tests are indeed go-no go and there is no "measurement" made. In that case, one can perform the trending on a p-chart (percentage or proportion) control chart. An advantage of using SPC control charts in conjunction with ISO is SPC is a pretty tried and true method that an auditor cannot say is an improper choice, as long as you follow your own rules established in your own procedure.
 
Thread starter Similar threads Forum Replies Date
G Requirement to follow Control Plan for serial production in a PPAP run APQP and PPAP 4
P On-going stability study requirement for medical device US Food and Drug Administration (FDA) 2
F CQI-22 - CQI-12 Requirement for Mills IATF 16949 - Automotive Quality Systems Standard 5
R Regarding UL Certification requirement CE Marking (Conformité Européene) / CB Scheme 6
U Does Medical Device training video falls under labeling requirement ? Other US Medical Device Regulations 4
M Citing Against Requirement 7.1.4 Environment for the operation of processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 59
M Is there a mandatory requirement to notify customers of the complaint resolution in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
S AS9120 - New Internal Auditor Training requirement? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
I Brazil clinical data/trial requirement Other Medical Device Regulations World-Wide 1
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 11
D Packaging requirement ? EU Medical Device Regulations 0
C Isolation requirement for USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C Creepage requirement Wearable ECG IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
V IATF 16949 GM CSR 10.2.4 Error-proofing requirement IATF 16949 - Automotive Quality Systems Standard 2
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 3
CaliperJim Uncertainty and Accuracy Requirement Deviation Provision General Measurement Device and Calibration Topics 2
Y Software to Manage IEC 62304 Traceability Requirement IEC 62304 - Medical Device Software Life Cycle Processes 3
Ajit Basrur Where to find a pagination requirement as "Page x of y"? ISO 13485:2016 - Medical Device Quality Management Systems 7
T Logistics and 3PL regulatory requirement in India for Pharmaceuticals and Med devices Other Medical Device Regulations World-Wide 0
G ISO 9001 - when implementing customer requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
H Regarding external surface temperature limit requirement for lab incubators. CE Marking (Conformité Européene) / CB Scheme 2
H OTC DRUG Private Labelling Distributor: GMP REQUIREMENT ISO 13485:2016 - Medical Device Quality Management Systems 0
R UDI Requirement at home patient use EU Medical Device Regulations 2
L Definitions Requirement ISO 14971 - Medical Device Risk Management 10
D What distributor requirement should we (manufacturer) require from the Distributor? EU Medical Device Regulations 4
Y Brazilian lab requirement for medical device manufacture Other Medical Device Regulations World-Wide 1
J QTC Requirement as per API 6A-21st Edition Oil and Gas Industry Standards and Regulations 1
J NADCAP Root Cause - Misinterpretation of Checklist Requirement Various Other Specifications, Standards, and related Requirements 5
eldercare Multi-Site ISO/AS Certification Requirement for some sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
H FAI Requirement After Moving CNC Machine? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
S Biocompatibility requirement for electrode adapters Other Medical Device Related Standards 1
briteme4 AS9102 FAIR Requirement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Put on escalation by customer? is there a requirement to notify registrar? IATF 16949 - Automotive Quality Systems Standard 6
E Translation requirement labels EU Medical Device Regulations 4
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
C Requirement for Revision of Standard in all Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K ROHs compliance requirement REACH and RoHS Conversations 10
E Language requirement DoC EU Medical Device Regulations 6
I QMS monitoring, measurement, analysis and evaluation requirement - Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Requirement for Signature on Document Document Control Systems, Procedures, Forms and Templates 14
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
Javier Guan Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
W Pfmea function requirement and failure mode FMEA and Control Plans 6
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 8
J When PPAPs are not a contractual requirement APQP and PPAP 9

Similar threads

Top Bottom