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Editor’s note: Quality Digest will host Richard DeRisio’s webinar, “Effective Strategies for Complaint Handling” on April 16, 2013, at 2 p.m. Eastern. Register here. DeRisio will also be a guest on Quality Digest Live on Friday, April 12, 2013, at 11 a.m. Pacific.
FDA’s regulation for “complaint files,” 21 CFR 820.198, is virtually unchanged since it was originally published in 1976. With all these years to perfect the content of the required forms and procedures, why is the regulation, as of this month, the most frequently cited FDA 483 Inspectional Observation? The regulation continues its run as the first or second most common FDA citation for the past several years.
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Comments
who's complaint manager?
Certainly quality pros' can contribute to the process; whether they should, I'm quite perplexed. Because all too often the top management echo one of the most famous french kings, that is "la qualité c'est moi !" - I 'm the quality. Statistically speaking, how many complaints are positively responded to the consumers? And how many consumers trust their suppliers' complaint handling system? Thank you.
True that
Successful firms are transforming their customer complaints into business success through the use of centralized complaints management programs like a Complaint management system. Service excellence, customer responsiveness, and customer trust are key ingredients for retaining customer loyalty in the industry today.
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