Risk Management during Contract Review

S

SBraddyQMR

#1
#1
Hi there! This is only my 2nd post on the forum, however, I lean heavily on this site for AS9100 guidance - simply wouldn't know how to do my job without y'alls help for which I'm very grateful! A little about me -- I had a 30 year career in the Human Resources field, ending up as VP, that is until the recession took hold, then I'm in the unemployment line with millions of others. Not old enough to retire <<<sigh>>> a friend asked me to come on board as his Quality Manager --- knowing full well I had NO AS9100 knowledge at all! I'm still here after 3 years and have earned a lot more gray hair as a result!

My question to you is.... If risks on continuous repeat (blanket) orders have been mitigated during contract review, and/or no action is required; are we still required to list the risks on each and every order they submit?

Thank you in advance! Sharon
 
Download Free White Paper
Elsmar Forum Sponsor
D

dsanabria

Quite Involved in Discussions
#5
#5
SBraddyQMR said:
Hi there! This is only my 2nd post on the forum, however, I lean heavily on this site for AS9100 guidance - simply wouldn't know how to do my job without y'alls help for which I'm very grateful! A little about me -- I had a 30 year career in the Human Resources field, ending up as VP, that is until the recession took hold, then I'm in the unemployment line with millions of others. Not old enough to retire <<<sigh>>> a friend asked me to come on board as his Quality Manager --- knowing full well I had NO AS9100 knowledge at all! I'm still here after 3 years and have earned a lot more gray hair as a result!

My question to you is.... If risks on continuous repeat (blanket) orders have been mitigated during contract review, and/or no action is required; are we still required to list the risks on each and every order they submit?

Thank you in advance! Sharon
Click to expand...
Here is what the standard says

7.1.2 Risk Management

"The organization shall establish, implement and maintain a process for managing risk to the achievement of applicable requirements, that includes as appropriate to the organization and the product."

So, while there is no requirement to perform a risk assessment, if it is not applicable or appropriate, it will be a good point to quickly verify that any previous risk are continue to be properly mitigated.

NOTE: the upcoming changes to the requirements is involving risk approach to other areas of production - start thinking mitigation for internal processes as well.
 
J0anne

J0anne

Joanne
#7
#7
Product liability law - if you do not communicate residual risk, you are still liable for any consequences. Standards are voluntary and law is not.
 
D

dsanabria

Quite Involved in Discussions
#8
#8
J0anne said:
Product liability law - if you do not communicate residual risk, you are still liable for any consequences. Standards are voluntary and law is not.
Click to expand...

While I follow you - please explain to the Aerospace folks in this forum how is it implemented without legalize. If it is not in the standard - auditors can not audit to it or write it up.

Residual risk or liability are flown down to everyone via a document call "Terms and Condition" - Not audited to the standard but reviewed by attorneys and owner.

The original question wanted to know if the risk assessment of the process needed to be re-evaluated every single time.
 
S

SBraddyQMR

#9
#9
dsanabria said:
While I follow you - please explain to the Aerospace folks in this forum how is it implemented without legalize. If it is not in the standard - auditors can not audit to it or write it up.

Residual risk or liability are flown down to everyone via a document call "Terms and Condition" - Not audited to the standard but reviewed by attorneys and owner.

The original question wanted to know if the risk assessment of the process needed to be re-evaluated every single time.
Click to expand...
EXACTLY!! :applause: Thank you DSanabria! I was getting lost with terms I could not locate in the standard!
 
G

gpainter

Quite Involved in Discussions
#10
#10
From a liability perspective I believe only if something has changed does a RA need to be done. Regardless, I believe that you should do a review every three years. One never knows what has changed or what is new that could reduce the risk. You will get sued, you will more than likely have to pay and it is just the question of "How Much?" Good RA will help keep the amounts down. If your Customer wants you to do it-then you have your answer!
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J What is Risk Management Review (during Product Planning) Risk Management Principles and Generic Guidelines 8
Q Risk Management ISO 14971 - Probability of Occurrence ISO 14971 - Medical Device Risk Management 8
Z Risk Management SOP ISO 14971 ISO 14971 - Medical Device Risk Management 1
M Risk Management Plan ISO 14971 - Medical Device Risk Management 4
thisby_ Installation Related Issues and Risk Management ISO 14971 - Medical Device Risk Management 5
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
G Help:Risk Management - Accessories US Food and Drug Administration (FDA) 1
N Writing Risk Management procedure for small manufacturing and we don't know where to start. Manufacturing and Related Processes 9
M Clinical evaluation interface with the risk management process EU Medical Device Regulations 9
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
B Risk Management Procedure updates needed for 14971:2019 ISO 14971 - Medical Device Risk Management 11
M Intended Use vs Actual Use and Scope of Risk Management EU Medical Device Regulations 8
S IDCB 0129/0160 Clinical Risk Management ISO 14971 - Medical Device Risk Management 2
A Risk Management Team IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
S Risk Management File - Procedure Packs ISO 14971 - Medical Device Risk Management 3
G Risk Management for IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
K Do you have separate clinical risk management group or experts in your manufactures? EU Medical Device Regulations 4
Sidney Vianna ISO Practical Guide on ISO 31000:2018 - Risk Management Other ISO and International Standards and European Regulations 0
T Risk Assessment and Management Misc. Quality Assurance and Business Systems Related Topics 0
J HELP NEEDED ! Risk Management Exercise ISO 14971 - Medical Device Risk Management 12
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 13
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
H Risk Management Plan in agile process ISO 14971 - Medical Device Risk Management 14
U Supply risk management Manufacturing and Related Processes 4
T Biological Evaluation (10993) & Risk Management ISO 14971 - Medical Device Risk Management 9
D Cybersecurity and Risk Management: Loss of confidentiality IEC 62304 - Medical Device Software Life Cycle Processes 5
S Risk Management Review ISO 14971 - Medical Device Risk Management 4
S Risk Management and other Files ISO 14971 - Medical Device Risk Management 8
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
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 16
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, NADCAP and Aerospace related Standards and Requirements 3
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

Similar threads

Top Bottom