Risk Management in terms of Technical and Commercial Failure (Disaster Recovery)

S

shohreh

#1
Dears,

Hope this message finds you well.

I'm working on creating a process related to the risk management in term of technical and commercial failure for any product or service. As an example: if any technical failure happened how it should be taken into consideration and how it communicated to the concerned and the commercial responses to the customers.

highly appreciate if you would be provide with any sample process if available.

at the same time would appreciate if any body can help me in creating disaster recovery process.

thank you in advance and best regards,
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Dears,

Hope this message finds you well.

I'm working on creating a process related to the risk management in term of technical and commercial failure for any product or service. As an example: if any technical failure happened how it should be taken into consideration and how it communicated to the concerned and the commercial responses to the customers.

highly appreciate if you would be provide with any sample process if available.

at the same time would appreciate if any body can help me in creating disaster recovery process.

thank you in advance and best regards,
Hi,

For disaster recovery process, you could start here:

http://en.wikipedia.org/wiki/Business_continuity_planning

Cheers,
Ronen.
 
M

marcellarhughes

#3
Understanding and allocation of risks involved in any investment or work is called risk management. First, you need to do a thorough study of the subject to understand the risks involved. Then for each risk you choose a way to allocate it such as buying insurance or having some contractual obligations for other parties involved in the work or the investment, such as Disaster Recovery.
 
J

JaneB

#4
shohreh

I strongly recommend you get a copy of and use AS/NZS ISO 31000:2009 Risk management - Principles and guidelines - it's the Risk Management Standard and sets out a very clear process to follow.

With Disaster Recovery are you talking about recovering from an IT disaster, or are you using the term more loosely, perhaps meaning Business Continuity?
 
Thread starter Similar threads Forum Replies Date
W ISO 13485 Risk Management in Simple Terms ISO 13485:2016 - Medical Device Quality Management Systems 22
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 10
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 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 1
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, NADCAP and Aerospace related 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, NADCAP and Aerospace related Standards and Requirements 7

Similar threads

Top Bottom