Introducing a risk/impact assessment to nonconformity procedure

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V

vanputten

#12
"Do you use your process to merely prioritise nonconformities/deviations or do you also use it as a rationale for not initiating an investigation/action plan?"

Initiating some type of risk assessment (FMEA) is doing investigation.

However, the first sentence of 8.5.2 and 8.5.2 c all refer to actions to elimnate the cause. This is hard to do if a nonconformity is determined to not require corrective action because the effect of the nonconformity has been identified as low risk.

At the same time, a company may go out of business dedicating resources to every nonconformity no matter what the effect is.

I think your plan is a good one. Identify the risk of the effect of the nonconformity and decide the action to be taken based on the risk assessment.

Regards,

Dirk
 
Q

qekim

#13
In my Company we are currently drafting an update to our CAPA procedure, we need to add some sort of risk assessment (RA), not to justify not performing a CA but rather to try to prioritise the CAPA and set the time to closure to the level of risk, if the risk is great to the user or patient than we take immediate action ( including possible recall) to investigate and have a short time to closure (30 days typically). For severe issues it seems pretty straightforaward, close it quickly and effictively, however for something minor ( an audit observation ) the process of performing a rick analysis is going to be burdensome and probably not worth the effort.......

My question is how do we best prioritise a CAPA? are we going to have to perform the same RA for all issues? or is there an other way?

for reference;currently we proposing a scoring system

Assessment of the likelihood of occurrence of the potentially hazardous event for each population at risk
• Remote 0 (0.005% or less)
• Rare +1 (0.006% - 0.09%)
• Occasional +2 (0.10% - 2.49%)
• Frequent +3 (2.50% - 9.99%)
• Continuously occurring +4 (>10%).

Probability of injury occurring to the population at risk or exposed
• Extremely unlikely 0 (0.005% or less)
• Unlikely but possible +1 (0.006% - 0.09%)
• Likely +2 (0.10% - 2.49%)
• Very likely +3 (2.5% - 9.99%)
• Extremely likely +4 (>10%)
NOTE: The assigned rating is based upon measured or estimated probabilities from calculation or interpretation by clinical personnel.

Severity of the injury or adverse health outcome (that might reasonably be expected to occur)
• None (no adverse health consequences) 0
• Limited (transient, self limiting illness or injury) +1
• Moderate (significant impairment but temporary/reversible) +2
• Severe (serious injury, permanent impairment) +4
• Life Threat (life threatening, death) +4

The scores from each section of the risk index are totaled to determine the overall hazard / risk index:
• 0 – 3 None / negligible
• 4 – 6 Low
• 7 – 9 Moderate
• 10 – 12 High

For trhe non Medical Device people this scoring system is the same we use to assess whether or not a recall is required.Obviously this is way over the top for a minor systems nonconformance or gap and does not assess buisness risk or impact.
 
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