Risk Management

Elsmar Forum Sponsor
L

Lassitude

#2
Can you give us a few more details, Howard? I'm not familiar with any 'canned' Risk Management forms or plan(s). Did they specify what type of risk or in relation to what?
 

Howard Atkins

Forum Administrator
Staff member
Admin
#3
All I have is a memeo that says " - will provide a "Risk Management Plan" to Ford purchasing and copy engineering".
According to those there the requestee did not know what he was asking for.
 
R

Roger Eastin

#4
In the old forum, there was quite a bit of discussion about risk management. You may want to check there for that thread. There was, in particular(if I recall correctly), an Australian gentleman, whose name I can't remember now, that had some sort of responsibility for developing risk management programs. Anyway, check the old forum for that thread.
 
Thread starter Similar threads Forum Replies Date
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
T How do you define your Hazards? <a Risk Management discussion> ISO 14971 - Medical Device Risk Management 6
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
B ATP 5-19 "Risk Management" Misc. Quality Assurance and Business Systems Related Topics 2
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
R Risk Management in the Medical Device Industry ISO 14971 - Medical Device Risk Management 4
F Linking an ISO 31000 Risk management SOP to ISO 17025 ISO 17025 related Discussions 2
Ronen E The unbearable insensitivity of risk management language Other Medical Device and Orthopedic Related Topics 1
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
M Risk/Benefit vs. benefit-risk - Revising an SOP covering Risk Management with the MDR in mind EU Medical Device Regulations 10
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
R Linking the Processes of Continual Improvement, Change Management, Risk Management, Action Planning, etc? Preventive Action and Continuous Improvement 5
D Risk management according to ISO 14971 - When to document risk controls? ISO 14971 - Medical Device Risk Management 10
J Software for Techfiles and Risk management ISO 14971 - Medical Device Risk Management 1
M Informational ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 6
M Medical Device News ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 0
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
M Informational ISO TC 210 JWG 1 meeting in São Paulo – Revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management Medical Device and FDA Regulations and Standards News 0
T Risk Management Report as per MDR Requirements EU Medical Device Regulations 4
S Medical Device Cybersecurity Risk Management File ISO 14971 - Medical Device Risk Management 2
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
Q Evidence of precautions (clinical evaluation report, risk management report) EU Medical Device Regulations 6
Q Risk / benefit Analysis in Risk Management Report CE Marking (Conformité Européene) / CB Scheme 12
A How to view supplier APQP timeline and do risk management APQP and PPAP 4
O Medical Device EMC Risk Management CE Marking (Conformité Européene) / CB Scheme 4
S ISO 13485:2016 - How I can integrate a risk management approach in our SOPs ISO 13485:2016 - Medical Device Quality Management Systems 1
B Time necessary for all Risk Management activities ISO 14971 - Medical Device Risk Management 2
W Virtual Manufacturer and Risk Management ISO 14971 - Medical Device Risk Management 3
O CQE Handbook - Missing Section VII - Risk Management Misc. Quality Assurance and Business Systems Related Topics 1
F Medical Device HACCP (Hazard Analysis and Critical Control Point) Risk Management ISO 14971 - Medical Device Risk Management 2
J Differences between a Risk Management Plan vs. Production Part Approval Process AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
M Free Risk Management Webinar - Design for Quality - May 2017 Risk Management Principles and Generic Guidelines 1
J Will this fulfill the AS9100D Risk Management Requirement AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
A Including all Processes in Risk Management - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 8
F Risk Management vs. FMEA ISO 14971 - Medical Device Risk Management 11
T Using Risk Management in ISO 10993 - Medical Device Accessory 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Risk Management - Additional Process in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
J What ever happened to Medical Device Risk Management, anyway? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
M AAMI draft report - Postmarket Risk Management ISO 14971 - Medical Device Risk Management 2
L Risk Management in an IVD, ISO 13485 certified company ISO 14971 - Medical Device Risk Management 2
S Informational Risk Management Implementation for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 60
S Risk Management during Contract Review AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
M Risk Management File for Extra Oral RX Equipment ISO 14971 - Medical Device Risk Management 11
D Risk Management for Drug-Device Combinations ISO 14971 - Medical Device Risk Management 1
A AS 9100 - Risk Management Procedure and Flow Chart examples AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
R How to document the Risk Management on Rework activities ? ISO 14971 - Medical Device Risk Management 6
Similar threads


















































Top Bottom