AGILE PLM - Deviation - What is the "Assigned Owner" Field

alonFAI

alonFAI

Involved In Discussions
#1
#1
HI GUYS

I opened a deviation in the agile PLM. under the "cover page" tab if you go down to page 3 there is a field called "Assigned Owner". can anyone explain the meaning of this field? who is the "Assigned Owner" and what his purpose in the process.

thanks!!
Alon:applause:
 
How to manage your QMS while working remotely.
Elsmar Forum Sponsor
B

Bjourne

#4
#4
I remember our customer referring to that as "process owner" usually the process engineer assigned to the process. I still have to look for the docs but I am not at work.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C Experience with Agile PLM (Product Lifecycle Management Software) software from Oracle? Document Control Systems, Procedures, Forms and Templates 3
M Oracle Agile PLM Software Reviews - Oracle Agile, others? Quality Manager and Management Related Issues 2
D Seeking PDM/PLM Systems Recommendations / Reviews - Looking at SmarTeam and Agile Software Quality Assurance 2
N Agile SOP for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
L AS9100 and Agile development processes AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
N Medical Device Software - Switch from Waterfall to Agile methodology Medical Information Technology, Medical Software and Health Informatics 4
R Training to Effective Documents - Transitioning to Agile Document Control Systems, Procedures, Forms and Templates 5
Z Agile Software Development and 510(k) Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Agile 9.3.1 Relationship Searches - Meaning of Message Manufacturing and Related Processes 1
L AAMI TIR(SW1)/Agile Practices in the Development of Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 8
AmandaMusser Documentation Confusion - Agile BOM Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Data Migration Validation - AGILE to (ARAS) Innovator Software Quality Assurance 3
Q Can Agile Methodology Principles be used for CA/PA/CI projects? Preventive Action and Continuous Improvement 6
B AGILE Project Management Process for Product Design Document Control Systems, Procedures, Forms and Templates 2
F Conversion from Agile - Need cheaper FDA compliant software Qualification and Validation (including 21 CFR Part 11) 7
S Using Agile for Quality System Documentation Control Document Control Systems, Procedures, Forms and Templates 5
R Document Control and Agile Product Lifecycle Management software Document Control Systems, Procedures, Forms and Templates 4
D Agile and Oracle - Does anyone have experience with Agile integrated with Oracle? Quality Tools, Improvement and Analysis 2
M Agile Software Development - The Manifesto for Agile Software Development Software Quality Assurance 11
D EExtreme / agile software development Software Quality Assurance 1
V OEM / PLM Japan Japan Medical Device Regulations 0
A Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability? Other US Medical Device Regulations 10
QIE QMS and PLM software recommendations Medical Information Technology, Medical Software and Health Informatics 6
S OEM and PLM under MDR EU Medical Device Regulations 2
J RoHS/REACH Compliance Tools and PLM Integration RoHS, REACH, ELV, IMDS and Restricted Substances 14
P OBL / PLM within the US Medical Device Market 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Anyone use PDMWorks or Omnify PLM software packages? Quality Assurance and Compliance Software Tools and Solutions 9
A How to Implement PLM on Compliance Management of Electronics Parts RoHS, REACH, ELV, IMDS and Restricted Substances 5
D Who is doing an integrated PLM (Product Lifecycle Management) system? Document Control Systems, Procedures, Forms and Templates 6
D Oracle PLM - Anyone out there using Oracle PLM or know anything about it? Quality Assurance and Compliance Software Tools and Solutions 0
P ECO Disposition - Deviation Needed for Use As Is? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
J Class Fixed ME Equipment (US Deviation) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
M Deviation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Average and standard deviation of Cumulative Data Statistical Analysis Tools, Techniques and SPC 5
E IEC 60335-1 power input deviation - Table 1 Values Other ISO and International Standards and European Regulations 0
P Large data sets of continuous individual data - Estimated or actual deviation Capability, Accuracy and Stability - Processes, Machines, etc. 2
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
V Acceptable maximum RSD (relative standard deviation) for an sample size Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
C Deviation in Design verification Other Medical Device Related Standards 6
S When should a note-to-file be used in a QMS vs Deviation Report ISO 13485:2016 - Medical Device Quality Management Systems 1
Coury Ferguson MiniTab 17 Question-Standard Deviation Default Capability, Accuracy and Stability - Processes, Machines, etc. 5
S When a deviation is opened but what does it mean to close a deviation? Misc. Quality Assurance and Business Systems Related Topics 1
K Please Help! what is ARL for the range and standard deviation Statistical Analysis Tools, Techniques and SPC 0
S Standard Deviation Selection on Control Charts - Minitab "pooled deviation" Statistical Analysis Tools, Techniques and SPC 3
T IATF 16949 - Customer Authorization for Concession or Deviation Permit IATF 16949 - Automotive Quality Systems Standard 22
B IFU and deviation 7 in ISO 14971 Annex ZA ISO 14971 - Medical Device Risk Management 1
G Should the Quality Department originate a Request for Deviation to the Customer? Nonconformance and Corrective Action 3
V Looking for advice on Pooled Standard Deviation between Minitab and MS Excel Statistical Analysis Tools, Techniques and SPC 1
Similar threads
Top Bottom