Implementing change in R&D - QA

v9991

Trusted Information Resource
#1
Background....
Ours is a very relatively-new function of ""QA in R&D"".(pharma domain)

Typically, people are recruited from manufacturing background. and they are seasoned to the 'verification'&'accuracy' - 'compliance' type of work.

But what is required is án mindset oriented towards establishing 'adequacy' & 'requirements'.

Management is expecting the process&results in establishing robustness of manufacturing process and drive towards current trends...

Problem/Situation
But the Sr.QM team is caught up in the web of constraints-
1 driving the R&D teams towards accepting the newer concepts (R&D is avoiding them in the name of no-time for new processes )
2) orienting/leading the QA-team towards the ""change in mindset"".(accuracy --> adequacy)
3) essentially not having appropriate targets to demonstrate the progress/incentivise the change. (metrics)

ANS PLZ
what would you try/recommend for a person who is lower level of team.
Esp. for a person who is trying out couple of alternatives...
1) establishing expectations/requirements along with relevant-processes
2) demonstrating the ideas & value/pilots of those ideas in bringing awareness/examples to team
(consensus is what is missing among QM group...remember ppl from mfg. background...resistance to change... )


thanks for your thoughts.:eek:::frust:
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Background....
Ours is a very relatively-new function of ""QA in R&D"".(pharma domain)

Typically, people are recruited from manufacturing background. and they are seasoned to the 'verification'&'accuracy' - 'compliance' type of work.

But what is required is án mindset oriented towards establishing 'adequacy' & 'requirements'.

Management is expecting the process&results in establishing robustness of manufacturing process and drive towards current trends...

Problem/Situation
But the Sr.QM team is caught up in the web of constraints-
1 driving the R&D teams towards accepting the newer concepts (R&D is avoiding them in the name of no-time for new processes )
2) orienting/leading the QA-team towards the ""change in mindset"".(accuracy --> adequacy)
3) essentially not having appropriate targets to demonstrate the progress/incentivise the change. (metrics)

ANS PLZ
what would you try/recommend for a person who is lower level of team.
Esp. for a person who is trying out couple of alternatives...
1) establishing expectations/requirements along with relevant-processes
2) demonstrating the ideas & value/pilots of those ideas in bringing awareness/examples to team
(consensus is what is missing among QM group...remember ppl from mfg. background...resistance to change... )

thanks for your thoughts.:eek:::frust:
Can someone help?

Thank you!

Stijloor.
 
Thread starter Similar threads Forum Replies Date
A Implementing a change for a particular Process - Document & Change Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
kisxena Implementing Change Control on Company Website ISO 13485:2016 - Medical Device Quality Management Systems 7
K Culture Shock and Things Need to Change - Implementing ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
A Change Management - What to look for before implementing a change? QS-9000 - American Automotive Manufacturers Standard 7
H Implementing ISO22301 on a Limited Scope Business Continuity & Resiliency Planning (BCRP) 1
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
L Implementing the PRRC role in a company EU Medical Device Regulations 7
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
B Lessons Learned Implementing ISO 50001 (Chemical Engineering Progress) Other ISO and International Standards and European Regulations 0
C How medical device manufacturers are implementing standards like GDPR and HIPAA Other ISO and International Standards and European Regulations 5
M Informational EU – Commission Implementing Decision (EU) as regards the designation of expert panels in the field of medical devices Medical Device and FDA Regulations and Standards News 0
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
tnorton Lessons learned from implementing Customer Complaints Customer Complaints 1
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
S Implementing a 45001 Health & Safety standard - Internal audit plan wanted Internal Auditing 1
M Informational Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Medical Device and FDA Regulations and Standards News 0
J Implementing Machine Replacement Part Reverse engineering technology Manufacturing and Related Processes 3
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
I First Time Implementing Document Control for ISO-9001 - how far back do you go? Document Control Systems, Procedures, Forms and Templates 15
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
J Implementing EN 62304:2006 on existing and proven medical devices IEC 62304 - Medical Device Software Life Cycle Processes 6
M Medical Device News MDR and IVDR implementing measures rolling plan EU Medical Device Regulations 0
B Implementing an Escalation Process and Andon system Supplier Quality Assurance and other Supplier Issues 1
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
T Is there any requirement to be compliant with IEC 62304 while implementing ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
A Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and... ISO 14001:2015 Specific Discussions 1
G Heavy Civil Construction Company Implementing ISO 9001:2015 for Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Implementing ISO13485:2016 in the Middle of a New Device Project ISO 13485:2016 - Medical Device Quality Management Systems 1
D Implementing 5S for Multiple Shop Floor Layout Workstations Lean in Manufacturing and Service Industries 2
N FDA Guidelines for implementing Continuous Improvement Process US Food and Drug Administration (FDA) 5
Q Easy Way of "Implementing" Risk in ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N Implementing ISO 17025 in a Calibration Laboratory ISO 17025 related Discussions 8
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Implementing an AS9100 Aerospace Quality System AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
L Implementing ISO 9001 in small Trading Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Implementing a set of bore gages at a machine Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A Implementing Risk Management in a Medical Device "Distributor Only" company ISO 13485:2016 - Medical Device Quality Management Systems 2
T Implementing a Suspect Counterfeit Identification Program Quality Manager and Management Related Issues 3
O Implementing Lean Intranet Sharepoint Lean in Manufacturing and Service Industries 6
F Implementing ISO 9001:2008 in a new Food Processing company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 22301 - Implementing a Business Continuity Management System Business Continuity & Resiliency Planning (BCRP) 15
M Does anyone here have experience implementing PCI DSS (Data Security Standard) IEC 27001 - Information Security Management Systems (ISMS) 10
L Implementing a new quality management system for a new engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Implementing ISO 9001 in an Assembly Plant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Understanding and implementing ISO 17025 ISO 17025 related Discussions 9
Q Implementing ISO 9001 and ISO 22000 systems at the same time Document Control Systems, Procedures, Forms and Templates 2
E Implementing a Production Accountability Program Manufacturing and Related Processes 3
J Implementing a TrackWise eQMS System Quality Assurance and Compliance Software Tools and Solutions 3

Similar threads

Top Bottom