Customer complaints

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Customer Complaints SystemPrepared By: reema A. Al-shoubaki : 

Customer Complaints SystemPrepared By: reema A. Al-shoubaki Quality Assurance Department

Objective: : 

To clarify the procedure followed by QA department for receiving, investigating & responding to customer complaint. Objective: 18/03/2010 Prepared By: Eng.Reema A. Al-Shoubaki

QA Complaint System : 

QA Complaint System Consist of the following: # SOP # Customer Complaint Report # Customer Complaint Report Logbook # Internal Complaint Investigation Report 18/03/2010 Prepared By: Eng.Reema A. Al-Shoubaki

Classification of Complaints : 

Classification of Complaints All Complaints are classified by QA according to the types of defect as follows: ❶Not Considered as a Complaint: Complaints not affecting product quality. ❷Minor Defect: Due to external factors which are not likely to cause any adverse consequences. ❸Major Defect: Due to improper GMP Compliance, which is not likely to cause health consequences. ❹Critical Defect: Due to violation to GMP or due to quality changes reflecting stability problems, which may or may not cause adverse health consequences. 18/03/2010 Prepared By: Eng.Reema A. Al-Shoubaki

Examples on Major Complaints : 

Examples on Major Complaints 1. Leakage : Suppositories & Syrup due to … machine or IPC checks. 2. Missing Tablets or Capsules due to… no cameras or sensors on blistering machine, IPC checks or improper inspection. 3. Broken Tablets due to …machine, low hardness tablets 4. Missing Blister due to …. No check weigher 18/03/2010 Prepared By: Eng.Reema A. Al-Shoubaki

Examples on Minor Complaints : 

Examples on Minor Complaints 1. Broken bottle, wetting or crushing of outer pack due to …. Mishandling (Not considered as a complaint) 2. Dejected PVC/Al foil due to …. During blistering 18/03/2010 Prepared By: Eng.Reema A. Al-Shoubaki

Examples on Critical Complaints : 

Examples on Critical Complaints 1. Change in appearance due to .... Physical / Chemical effect , stability 2. Mislabelling due to ... Violation to GMP (Mix-up) , Supervision 3. Foreign Particles due to .... Violation to GMP / Hygiene , Supervision & Line Clearance 18/03/2010 Prepared By: Eng.Reema A. Al-Shoubaki

Recommendations: : 

1. Check weighers are required to be used during blistering operations to eliminate complaints on missing tablets/capsules or empty pack/blister. 2. Raise of hygiene and line clearance concept in production. Recommendations: 18/03/2010 Prepared By: Eng.Reema A. Al-Shoubaki

Recommendations: : 

4. Proper visual inspection is taking place at present by production department. 5. Automated filling & capping machine to be ordered to eliminate leakage problems like in case of Tic Tac Shampoo and Clindacin –T solution. Recommendations: 18/03/2010 Prepared By: Eng.Reema A. Al-Shoubaki

Recommendations: : 

6. Reason of leakage from suppositories cavities after sealing to be checked to minimize from this complaint. 7. Extra training is being conducted to all packaging employees. Recommendations: 18/03/2010 Prepared By: Eng.Reema A. Al-Shoubaki

Thanks : 

Thanks 18/03/2010 Prepared By: Eng.Reema A. Al-Shoubaki