A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 13th Year of Publication
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Quality

Firms generally dislike the following features in their software applications (i.e., questions that firms should ask when evaluating a web-based system):

  • Long configuration time
  • Training employees is a challenge
  • Difficulty in generating reports
  • Annual cost of updates and maintenance
  • Difficult to modify the program to meet firm's needs

Motivating Customers and In-House Personnel to Report Complaints

Survey respondents use the following tactics to motivate customers to report complaints:

  • Provide easy access for communication (toll free #, web site, receptive sales reps.)
  • Build a relationship by letting customers know you are trying to solve the problem
  • Provide technical assistance to facilitate proper device use
  • Go beyond the reported complaint to ensure total customer satisfaction
  • Make it easy for the customer to obtain a free replacement for a defective device

Survey respondents use the following tactics to motivate in-house personnel to report complaints:

  • Have top management reinforce the value to the business of effective complaint handling
  • Design a simple reporting form and provide training on its use
  • Publicize actions taken in response to issues raised by complaints.
  • Provide positive reinforcement for reporting, analyzing and acting upon complaints

Getting the Device Back From the Customer

65% report difficulty in this area.

Survey respondents used the following tactics to motivate people to return the device:

  • Be responsive: Have a courier or salesperson personally pick up the product
  • Provide free shipping and product replacement or credit
  • Continue to follow up with the customer until the firm gets the product back
  • Tell customers about the importance of their feedback in improving product quality
  • Provide information on corrective and preventive actions

Not Investigating Complaints

The most popular reasons cited for not investigating complaints include:

  • Complaint is for a product not manufactured by the firm (55%)

  • An adequate investigation of the alleged compliant failure mode has already been preformed (55%)

  • Corrective action is already open for the same failure mode (52%)

  • A failure investigation is already open for the same complaint (39%)

  • Complaint does not involve a possible failure of the device, labeling, or packaging to meet specifications (35%)

  • Firm is unable to obtain the device for analysis (21%)
    (The preamble to the QS Regulation contains information regarding making a "good faith" effort to recover devices. An investigation can include, for example, testing similar devices (e.g., same lot), reviewing DHRs and complaint historical data.)

Closing Complaints

Firms use the following criteria in determining when a complaint is considered closed:

  • A corrective action has been initiated or it has been determined that no action is required (42%)
  • A corrective action is reported (23%)
  • A failure investigation has been completed (20%)
  • A corrective action has been completed (1%)
  • Other (14%)

Goal for Closing Complaints

Firms reported the following time frames as a goal for closing complaints:

*     Less than 30 calendar days (37%)

  • 31 - 45 calendar days (18%)

  • 40 - 60 calendar days (23%)

  • More than 60 calendar days (1%) (These are probably the   firms who close complaints after the corrective action is implemented and closed.)

  • 16% Other

 * * * * *

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