Risk closeout , mitigation was not effective, next?

qualprod

Trusted Information Resource
#1
Hello everybody
Im facing certain doubts as to what actions to take after a risk was not mitigated properly, was high value, after evaluating residual ia almost same value.
I see two possible ways :
Because I have a document (risk analysis), ok
One way is to declare it ineffective first analysis and start a new one.
Other option could be to keep same analysis but adding other mitigation plans.

What action are you taking when risk mitigation was not effective?

Thanks for your help
 
Elsmar Forum Sponsor

John Broomfield

Leader
Super Moderator
#3
Hello everybody
Im facing certain doubts as to what actions to take after a risk was not mitigated properly, was high value, after evaluating residual ia almost same value.
I see two possible ways :
Because I have a document (risk analysis), ok
One way is to declare it ineffective first analysis and start a new one.
Other option could be to keep same analysis but adding other mitigation plans.

What action are you taking when risk mitigation was not effective?

Thanks for your help
qualprod,

And, of course, you’ll want to remove the system weaknesses that caused this ineffective risk analysis or risk treatment so it doesn’t happen again.

So, raise a corrective action request per the requirements of your management system. That is what you close out not the risk.

John
 
#5
Since mitigation is just to reduce the severity of the risk, can you put control (administrative, engineering, etc ) in such way that it reduces the likelihood of the risk or even eliminates it.

Id prefer to establish mitigation after establishing prevention to bring the risk to alarp.
 

qualprod

Trusted Information Resource
#6
Thanks Golfman25
As I understand, I'll declare risk analysis ineffective, because only 2 out of 4 actions for mitigation worked fine, as such will be closed out, but immediately will do the the analysis again (new analysis on same risk ).
Depending on the risk value I might decide to open a Ca when is ineffective.
On the other hand, I think the risk value is changed by implementing actions (mitigation)
risk value = occurrance x impact= risk vàlue, if Occurrence is low, of course risk value will change.
Is the way I understand both issues, are you agree, maybe I'm misunderstanding something.
PD
I think that criteria to open CA for each ineffective ,may be not recommended, it may be applied when is a repetitive failure on same risk.
Please give inputs, thanks
 

Ninja

Looking for Reality
Trusted Information Resource
#7
I think that criteria to open CA for each ineffective ,may be not recommended, it may be applied when is a repetitive failure on same risk.
Going back into plain language:

- We saw a risk.
- We decided it was worth some effort to lower it (by lowering impact or lowering chance of occurrence, whichever).
- We came up with four ideas that we thought would work.
- Two of the ideas actually WERE good, and they worked to our satisfaction.
- Two of the ideas weren't as great as we thought, and nothing really happened.
- ...So we're gonna come up with more ideas based on this lesson learned and try again.

Me...I would have this as part of the original risk management...I tried and failed so I'm trying something different. Case still open.
Probably OK to document that it didn't work, close it, and open a new one...it's all just paperwork.

I don't see a real need to burn calories on paperwork...burn calories instead on coming up with the thing that mitigates the risk. The concept here is similar to R&D...we don't know what will work, and we're trying to figure it out...and we're not done yet.

HTH
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#8
We may never "fully" mitigate a risk, as issues (I think of them as factors that enable risk) can change. There can also be more than one risk involved, and an opportunity can introduce its own risk.

We should not feel as though we must squash the thing completely, just address that which would bring value.
 

John Broomfield

Leader
Super Moderator
#9
Going back into plain language:

- We saw a risk.
- We decided it was worth some effort to lower it (by lowering impact or lowering chance of occurrence, whichever).
- We came up with four ideas that we thought would work.
- Two of the ideas actually WERE good, and they worked to our satisfaction.
- Two of the ideas weren't as great as we thought, and nothing really happened.
- ...So we're gonna come up with more ideas based on this lesson learned and try again.

Me...I would have this as part of the original risk management...I tried and failed so I'm trying something different. Case still open.
Probably OK to document that it didn't work, close it, and open a new one...it's all just paperwork.

I don't see a real need to burn calories on paperwork...burn calories instead on coming up with the thing that mitigates the risk. The concept here is similar to R&D...we don't know what will work, and we're trying to figure it out...and we're not done yet.

HTH
Ninja,

You make a fair point about persisting with ineffective processes that have yet to be validated.

But the “suck and see” approach to risk management is risky in itself.

So, we need to consider the consequences of inadequate understanding of the hazards and how to remove or mitigate the most damaging of these hazards.

I do admit that I’m playing it safe by advocating corrective action after the inherently risky RM processes have failed once.

Thanks for the reminder.

John
 

Ninja

Looking for Reality
Trusted Information Resource
#10
Well,
Maybe we're saying the same thing...but maybe not...so I figured I push on it again here...

"But the “suck and see” approach to risk management is risky in itself. "

Not 100% sure what you mean by this. Life is trial and error. If you're advocating thinking about pros and cons before trying, I'm 100% in agreement...but no matter how long you consider, you still have to try it to be sure.
...and since you're not 100% sure until after the try, it does (of course) involve its own risk...that's what every number below 100% includes...risk.

"So, we need to consider the consequences of inadequate understanding of the hazards and how to remove or mitigate the most damaging of these hazards."

Yup...that's why it's called "Trying"...
If we had complete understanding of the hazard and how to mitigate it, we'd be done already.

"advocating corrective action after the inherently risky RM processes have failed once"

Really not sure if I understand this. The real world steps are the same...I'm only seeing differences in documentation system...so perhaps I just don't understand what you're saying...it doesn't matter to me how its documented.
To me, it's pretty similar to Design Control...we don't know how to do what we want, and we're working to figure it out...
Putting this into CA on first failure seems to me like putting every R&D project into the CA system when the first try doesn't work.

Risk management totally IS NOT Design control...and I'm not saying it is...I'm just drawing the parallel in documentation approach.
 
Thread starter Similar threads Forum Replies Date
Q Risk (closeout and options for the addressing) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T AS9100D Risk-Based Internal Audit Schedule AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
thisby_ Installation Related Issues and Risk Management ISO 14971 - Medical Device Risk Management 5
W Reconciling FMEA RPN ratings with Risk Acceptability ISO 14971 - Medical Device Risk Management 11
D How to address the content deviation of 'cannot apply criteria of risk acceptability prior to...' ISO 14971 - Medical Device Risk Management 1
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
T Risk based CA AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T IVD Risk - destruction of patient samples - Harm to property? ISO 14971 - Medical Device Risk Management 5
E Do anyone have document of automotive production risk and control of risk? Lean in Manufacturing and Service Industries 1
R Using RPN to Confirm Risk Reduced to an Acceptable Level Risk Management Principles and Generic Guidelines 12
T IVD Device Software - Risk Classification IEC 62304 - Medical Device Software Life Cycle Processes 16
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
E How to risk assess tooling? For a medical device and is it needed??? Manufacturing and Related Processes 2
M Clinical evaluation interface with the risk management process EU Medical Device Regulations 9
L Risk analysis Manufacturing and Related Processes 4
J Risk Analysis for Proficiency Testing Reliability Analysis - Predictions, Testing and Standards 1
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 What is the Risk of Using Obsolete Versions of C=0 & ANSI/ ASQ Z1.4 Sampling Plans? ISO 13485:2016 - Medical Device Quality Management Systems 8
D AS9100D 8.4.2 Note 2 Significant Operational Risk AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Calculating Risk Estimation ISO 14971 - Medical Device Risk Management 29
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
H At what level (harm, hazardous situation, seq. of events, etc) is "risk" estimated? ISO 14971 - Medical Device Risk Management 12
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
B ISO 14001 Risk assesment ISO 14001:2015 Specific Discussions 4
J What risk to cover when NOT using ISO 17025 accredited/certified labs for calibration ISO 17025 related Discussions 3
G Risk Management for IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
S What is your favorite Usability Risk Analysis tool? IEC 62366 - Medical Device Usability Engineering 5
T Assessing risk where harm is indirect - Generic devices / accessories / intermediates ISO 14971 - Medical Device Risk Management 8
K Do you have separate clinical risk management group or experts in your manufactures? EU Medical Device Regulations 4
W IATF 9.2.2.1 Internal Audit how to determine risk IATF 16949 - Automotive Quality Systems Standard 12
S Risk control through Information for safety ISO 14971 - Medical Device Risk Management 12
A Derive Risk Acceptance Matrix from Risk Policy ISO 14971 - Medical Device Risk Management 8
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
I Estimation of overall residual risk. How to? EU Medical Device Regulations 11
Sidney Vianna ISO Practical Guide on ISO 31000:2018 - Risk Management Other ISO and International Standards and European Regulations 0
T IEC 62304 : Risk control for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 8
T Risk Assessment and Management Misc. Quality Assurance and Business Systems Related Topics 0
P Scenario based risk assessment IEC 27001 - Information Security Management Systems (ISMS) 1
Q KPI risk assessment - Criteria for the given score IATF 16949 - Automotive Quality Systems Standard 3
S Foreign Risk Notification Canada Medical Device Regulations 2
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
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Measurement Equipment Revocation - Looking for a Disposal Form with Risk Assessment IATF 16949 - Automotive Quality Systems Standard 10
B ISO13485 Risk managment implementation for suppliers ISO 14971 - Medical Device Risk Management 2
Moncia Chemical risk assessment / COSHH Manufacturing and Related Processes 5

Similar threads

Top Bottom