Risk analysis for qualifications machines

GOOD MANUFACTURING PRACTICE (cGMP) RISK ASSESSMENT
1

hello
I would like to extend the eligibility status of the machine without testing. Can I make a risk analysis, which will extend me the status one year. What should I take into consideration.

PLEASE help

2

Read this white paper from ISPE.

white paper.pdf (207.7 KB)

3

Dear Durga Prasad,

I would like to know Risk Assessment for Requalification equipnments as well as new equipments.
How can we do the Risk assessment for New and old Equipments?
How can we allot the score for probability, detectibility and severity?
What is the limit of the score i.e. lowest, moderative and Highly?
If we have a score that indicating Moderative & Highly risk so what will be there? What kind of measurements will be implementd?

Can i get one risk analysiss example document for anyone equipment please?

I am looking anxiously for your earliest response.

Thans in advance

Pullareddy Karnati

4

[quote=Pulla Reddy]Dear Durga Prasad,

I would like to know Risk Assessment for Requalification equipnments as well as new equipments.
How can we do the Risk assessment for New and old Equipments?
How can we allot the score for probability, detectibility and severity?
What is the limit of the score i.e. lowest, moderative and Highly?
If we have a score that indicating Moderative & Highly risk so what will be there? What kind of measurements will be implementd?

Can i get one risk analysiss example document for anyone equipment please?

I am looking anxiously for your earliest response.

Thans in advance

Pullareddy Karnati[/quote]

Dear Mr.Pulla Reddy

APIC published a guideline for qualification of existing equipments and it explained clearly about risk assessment approach for existing equipments.

For your ready reference guideline attached.

[attach]325[/attach]

For new equipments risk assessment you can follow FMEA tool.

Brief process introduction of FMEA is as follows:

You have to ensure the following pre-requisities prior to risk assessment.

  1. You have to identify the failure modes.
  2. Note the effects by failure modes.
  3. Mention the current controls for identified failure modes.

Evaluate the following during risk assessment.

  1. Evaluate the siverity, probability and detectability of failure modes.
  2. Calculate the risk priority number by multiplying SxPxD.
  3. Identify the causes of failure modes.
  4. Propose recommended actions to eliminate the causes of failure modes.
  5. Ensure proposed recommendations should be implemented.
  6. Again calculate RPN number after proposed recommendations implementation.

For your workup example FMEA work sheet attached below:

Rating and score of the Severity , Probability and Detectability addressed in the attachment

[attach]326[/attach]

Hope u clarified.

Thanks and regards

Qualification_existing_equipment_final.pdf (224.5 KB)

FMEA work sheet.doc (49.0 KB)