Risk Analysis - Same Risk Treatment for Context and Interested Parties

Q

QAMTY

Hi everybody

In doing the risk analysis in 4.1 and 4.2, following 6.1

I have identified in context people (internal) and competitors (external) but also have found the same for interested parties.

When addressing the risk and opportunities in both, could I apply the same
treatment?

O could I state that I dont need to analyze risk and opportunities for people and competitors in interested parties, because I have addressed them in Context?.

Please feed me back.
 

yodon

Leader
Super Moderator
The way I'm approaching it is that we have a "cloud" of considerations about which we do risk-based thinking; e.g., context, processes, interested parties, etc. Out of that cloud, we identify the actions that we want to take to mitigate risk or take on opportunities (we will not take action on every risk or opportunity). So we could certainly look at and 'combine' considerations.

Haven't been audited yet so I'm not sure how this will fly but it seems to make sense.
 
Q

QAMTY

Thanks yodon

The standard in 6.1, states to consider issues from 4.1 and requirements from 4.2 and to indentify R & O. However it is valid to not consider risk in processes which may be of very very low impact.

What Im doing regarding R & O it is:

For example some of them:
Int parties:
(external) suppliers, clients, goverment, competitors, (internal) employees, top management.

For Context.
(external)client, economical issues, market , technological issues
(internal) employees competence, processes performance, Top management leadership,etc

For each of them, Im running the Risk analysis by evaluating the risk values PXi and according to a reference table, I define the treatment needed.

That is the methodology Ive implemented, I hope it is worth the effort.

My audit will take place til january 2018.

Thanks for your comments

I hope other members could share their opinions.
 
Q

QAMTY

Thanks Randy
I dont understand your answer, could you explain it a little bit more? I guess it is a technical issue.
For me it is important your point of view.
 

AMIT BALLAL

Super Moderator
could any body explain requirement of surveillance Audit (up grade Audit) in iso 9001 2015

Seems like you are talking about transition to ISO9001:2015 (Upgradation from ISO9001:2008 to ISO9001:2015). Surveillance audits are smaller (50% of Stage-2 i.e. certification audit). But this audit will be similar to recertification audit. You'll require same data and records as required during recertification audit.
Eg. 12 months KPI data, Internal audit, Management review, etc.

I am considering you know the records required by ISO9001:2015 standard.
 
Last edited:
Thread starter Similar threads Forum Replies Date
T Article 22 procedure pack risk analysis EU Medical Device Regulations 1
S Risk analysis on patient monitor ISO 14971 - Medical Device Risk Management 5
J Determination of software safety class (62304) prior to software risk analysis ISO 14971 - Medical Device Risk Management 3
G FDA requirements for risk analysis US Food and Drug Administration (FDA) 2
L HA vs risk analysis ISO 14971 - Medical Device Risk Management 2
K Help with ISO 14971: Benefit-Risk Analysis ISO 14971 - Medical Device Risk Management 3
L Risk analysis Manufacturing and Related Processes 4
J Risk Analysis for Proficiency Testing Reliability Analysis - Predictions, Testing and Standards 1
S What is your favorite Usability Risk Analysis tool? IEC 62366 - Medical Device Usability Engineering 5
H Risk Analysis and Probability of Occurrence ISO 14971 - Medical Device Risk Management 3
Booker Risk analysis for defective measuring or measuring equipment out of calibration General Measurement Device and Calibration Topics 2
P Benefit risk analysis on pFMEA ISO 14971 - Medical Device Risk Management 10
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2
E Normal Condition Hazards in Risk Analysis ISO 14971 - Medical Device Risk Management 3
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
R ECG Risk Analysis Standards ISO 14971 - Medical Device Risk Management 2
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
M IATF 16949 (6.1.1 - Planning and Risk Analysis for a remote site) Process Maps, Process Mapping and Turtle Diagrams 5
Dobby1979 Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
M An example of risk analysis of class I MD ISO 14971 - Medical Device Risk Management 36
T Risk analysis of QMS software - Validating software we use for QMS ISO 13485:2016 - Medical Device Quality Management Systems 7
B Grouping of Products for Risk Analysis ISO 14971 - Medical Device Risk Management 9
A Risk-benefit Analysis - Hazard Analysis (HA) and FMEAs ISO 14971 - Medical Device Risk Management 18
R The difference b/w FMEA & Risk analysis as per iso 14971 ISO 14971 - Medical Device Risk Management 8
K Risk Analysis Updates due to complaints ISO 14971 - Medical Device Risk Management 10
S The Severity of a Medical Device Hazard - Risk Analysis Clarification ISO 14971 - Medical Device Risk Management 6
Ed Panek Transition to IEC 60601 4th Edition - Risk Analysis and test submissions CE Marking (Conformité Européene) / CB Scheme 2
S In a risk analysis, how can we tie mobile app security breach to ISO 14971? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Risk / benefit Analysis in Risk Management Report CE Marking (Conformité Européene) / CB Scheme 12
R IATF 16949 Clause 6.1.2.1 - Lessons Learned and Risk Analysis IATF 16949 - Automotive Quality Systems Standard 6
S Risk analysis 6.1 and contingency plans 6.1.2.3, are they related? IATF 16949 - Automotive Quality Systems Standard 26
B Software Class A - Lengthy further risk analysis IEC 62304 - Medical Device Software Life Cycle Processes 9
W Biocompatibility Risk Analysis for Clinical Practitioner 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
FoGia Risk Analysis of a Medical Device Accessory ISO 14971 - Medical Device Risk Management 4
S How we can use risk analysis for suppliers IATF 16949 - Automotive Quality Systems Standard 6
I Medical Device Software Risk Analysis ISO 14971 - Medical Device Risk Management 4
C Risk Analysis for COTS/OTS Risk Management Principles and Generic Guidelines 4
M IATF 16949 Cl. 8.7.1.4 - Risk analysis for decision making about rework IATF 16949 - Automotive Quality Systems Standard 2
E Risk Analysis - Events which may cause to Data Loss ISO 14971 - Medical Device Risk Management 12
W Risk Benefit Analysis - ISO 14971:2012 Requirements ISO 14971 - Medical Device Risk Management 27
F Medical Device HACCP (Hazard Analysis and Critical Control Point) Risk Management ISO 14971 - Medical Device Risk Management 2
Q Risk Tools in ISO 31010 - Root Cause Analysis vs. Cause-and-effect Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Organizing Risk Analysis and Controls for a New Medical Device (ISO 14971) ISO 14971 - Medical Device Risk Management 4
S Please review my Risk Analysis Table ISO 14971 - Medical Device Risk Management 13
K Risk Analysis and "Information for Safety" / Labeling ISO 14971 - Medical Device Risk Management 10
M Risk analysis - ISO/TS 16949 clause 7.2.2.2 IATF 16949 - Automotive Quality Systems Standard 2
C Help with Risk/Benefit Analysis Self-help Device for Diabetics ISO 14971 - Medical Device Risk Management 3

Similar threads

Top Bottom