Risk Management Review

Seekingknowledgee

Involved In Discussions
#1
Hi All,

Should the "Risk Management Report" be changed to "Risk Management Review" in our Risk Management Files? And what about the content under it if it needs to be changed.

Thanks
 
Elsmar Forum Sponsor

Bev D

Heretical Statistician
Leader
Super Moderator
#2
Well words matter.
report is just a thing (noun). it is a record of sorts.
review is an action as in "to review the report". reports that are not reviewed by others are useless.
files are where reports go to disappear

what is your intent?
 

yodon

Leader
Super Moderator
#3
Not exactly sure where you're headed but, per the standard:

The results of this [risk management] review shall be recorded and maintained as the risk management report and shall be included in the risk management file.

(emphasis added)

So you document the results of the risk management review. You could include them or reference them in the report.
 

Jean_B

Trusted Information Resource
#4
In the update of ISO 14971:2012 to ISO 14971:2019 that section's header changed from "Risk management report" to Risk management review".
That namechange is less important than what changed within that clause, namely it is no longer a review of the risk management process (which could have focused on the 'procedure') but is on the execution of the risk management plan (so a realized part of risk management), as well as that information is no longer only obtained, but instead collected and reviewed. Last (but perhaps more least) assignment of responsibility for the review by way of the risk management plan has been changed from should to shall.
The clause keeps the record of the activity defined as "risk management report" in contrast to the section title's change. Reading between the lines the activity of reviewing actually executed risk management versus planned risk management has been made more important than simply having a report with certain line items, but the report is still an essential output of that activity.
Recommend: don't change the name of the report, do check whether you're now reviewing executed risk management versus plan, instead of procedure versus standard.
In my word for word redline I've seen the update to make many of such nuanced changes, but overall if you had the right spirit you were already doing the right stuff. If you were nitpicking for holes in the standard, then the update closed a lot (But I think there should have been enough grounds to stick it to any true abusers).
 
Thread starter Similar threads Forum Replies Date
S Risk Management during Contract Review AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
K Risk Management Procedure - Please review AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Risk Analysis as an Input in Management Review Management Review Meetings and related Processes 11
J What is Risk Management Review (during Product Planning) Risk Management Principles and Generic Guidelines 8
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 8
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 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 8
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
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

Similar threads

Top Bottom