Risk Management - Planning Stage (AS9100C Section 7.1.2(d))

E

Eloy Gomez

#1
AS9100C Section 7.1.2(d) The organization shall establish, implement and maintain a process for managing risk to the achievement of applicable requirements, that includes the identification, assessment, and communication of risks throughout product realization.

Question:

Do planners need to identify, assess and communicate the risks during the manufacturing process ?

OR

Do planners need to identify, assess and communicate the risks while planning the manufacturing process?

Thanks for your input in advance.
 
Elsmar Forum Sponsor

dsanabria

Quite Involved in Discussions
#2
Re: Risk - Planning Stage

AS9100C Section 7.1.2(d) The organization shall establish, implement and maintain a process for managing risk to the achievement of applicable requirements, that includes the identification, assessment, and communication of risks throughout product realization.

Question:

Do planners need to identify, assess and communicate the risks during the manufacturing process ?

OR

Do planners need to identify, assess and communicate the risks while planning the manufacturing process?

Thanks for your input in advance.
Here is the complete Quote from AS9100 C
"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"

"as appropriate" is the key word that will drive your system.

Keep it simple and look at your processes and associated risks - some of them will overlap and some risks are unique.

Short answer - great exercise if they do - they will learn a lot about the process.
 
Thread starter Similar threads Forum Replies Date
R Linking the Processes of Continual Improvement, Change Management, Risk Management, Action Planning, etc? Preventive Action and Continuous Improvement 5
J What is Risk Management Review (during Product Planning) Risk Management Principles and Generic Guidelines 8
V Planning of Product Realization - Risk Management - ISO 13485 Clause 7.1 ISO 13485:2016 - Medical Device Quality Management Systems 6
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
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

Similar threads

Top Bottom