Classification of CIR and Scaling the CIR based on GMP

STEP 1 - CIR Classification (In particular)

CIR Classification Scale

Raw Material : Ingredients related issues 10

Packaging Material : Sleeves, Cartons / Trays related issues 15
Finished Good : Issues related to Final Finished Goods 20
Customer Complaint – Goods found spoiled after opening 50
Customer Complaint - Related to improvement of Product/other 25
Customer Complaint – Straw / Packaging related 35
Production & Process Control : Issues related to process failures, equipment 50
& utensil
Building & Facility : Issues related to environmental hazard, pest, 15
Construction, problem, drainage, damage in plant (floor crack, peeling paints,
leakage in roof etc), employee facility (wash room, lunch room)
Personnel & Practices: Issues related Cleaning, Maintenance, Training, 25
Responsibility, Clothing, Shoes etc...
Procedures & Policies: Lack of procedure/policies, Problem in following the 25
procedures as per standard regulations, Internal Audit / External Audit

STEP 2 – Understanding the Severity (Detection details)

Detected during Scale

Regular Monitoring & Measurement 10
Accidentally found – Potential 40
Accidentally found – Not Potential 20
Customer Complaint – Potential 50
Customer Complaint – Not Potential 25
Not Applicable 0

STEP 3 – Actions Required

Required Actions Scale

Related department corrective action 10
Management Intervention/ Support 50
Need new systems implications 25

CIR scaled above 70 will be discussed in depth during Management Review meeting. Scaling can be revised
if required.