Solving Customer Problems
Can you help me solve my customer's complaint?
How we said yes:
Reviewed batch information and analytical results.
- All lots met specifications.
- No process changes had been made.
- No deviations were noted.
Developed new GPC and NMR methods to analyze and compare the batches of final product that were under investigation.
- Extraneous peaks were observed in one lot.
Evaluated raw materials.
- Both consigned and purchased raw materials met stated specifications.
- Purchased raw materials were analyzed by other methods and revealed no abnormalities.
The consigned starting material was analyzed by the new GPC and NMR methods. It was concluded that one lot of the consigned material had extraneous peaks.
Collaborated with corporate R&D for additional LC/MS support to identify the extraneous peaks. The new impurities were shared with the customer and supplier to aid in trouble-shooting their processes.
Developed a procedure for rework/reuse of the batches that showed the performance problems.
The yes formula benefits:
New analytical methods were implemented for:
- the starting material
- in-process checks
- final product
Participated in customer 3-way calls with:
- The suppler to tighten and add new specifications
- The customer's customer to explain observations and preventive measures
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