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Complaints: A Second Chance to "Make it Right"

Customer complaints can give medical device companies a wake-up call when they're not achieving their fundamental purpose: that is, meeting customer requirements. If orthopaedic companies don't deliver what they promise, i.e. meet the customer's requirements (the root cause of most complaints) the customers will go elsewhere.

Customer complaints can give medical device companies a wake-up call when they're not achieving their fundamental purpose: that is, meeting customer requirements. Complaints are a feedback mechanism that can help orthopaedic manufacturers rapidly and inexpensively shift products, service, style, and market focus. Businesses that don't value their customers' complaints suffer from costly, negative word-of-mouth advertising. In many ways, orthopaedics is a small industry from a standpoint of being closely knit and tightly networked. A recent poll found that 18% of adult Americans said that their trust in business had dropped in the last year. Ninety-three percent of those same complainers indicated that a company's reputation for honesty and fairness was very important to them. If orthopaedic companies don't deliver what they promise, i.e. meet the customer's requirements (the root cause of most complaints) the customers will go elsewhere.

Introduction to the Regulation – 21 CFR, Parts 198 and 803

The Quality Systems Regulation defines a complaint as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. All medical device manufacturers are subject to the complaint requirements in the Quality System Regulation and to the reporting requirements in Medical Device Reporting (MDR) regulation. A complaint is any indication of the failure of a device to meet customer or user expectations for quality or to meet performance specifications. A complaint may be lodged against any finished device that had been released for distribution. Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications is subject to the provisions of 21 CFR 820.198, Complaint Files.

Medical device companies are required to review, evaluate, and, when appropriate, investigate complaints, establish and maintain written procedures describing the process used to perform these activities, and designate a responsible individual or entity to perform these tasks. Complaints concerning death, serious injury or malfunctions, as defined in the MDR regulation (21 CFR, Part 803), shall be reported to FDA in a timely manner. Complaint file requirements are necessary to make certain manufacturers have adequate quality systems for investigating complaints and taking corrective action. Access to complaint files, device-related death and injury reports, and complaints about device defects enables FDA to determine if a manufacturer's quality system and corrective actions are adequate.

Complaint data, in conjunction with product audits, management audits, operational analyses, inspection and test data, etc., is used by the quality assurance organization to: 1) identify poor performance in the overall quality system, particularly faulty design of devices, and faulty manufacturing processes, 2) aid in implementing solutions to these quality problems, 3) verify confidence in, and improve the performance of the quality system, 4) improve the safety and performance of devices, 5) reduce medical device reporting, 6) reduce costs and improve production schedules, 7) reduce employee confusion, 8) improve customer relations by reducing the frequency of problems, complaints, and recalls, and 9) assure compliance with device regulations and consensus standards.

An Everyday Approach to Complaints – You Need:

    • Written Procedures: A written procedure for handling customer complaints that everyone in the company has been trained on, not just customer service reps or your receptionist.
    • Clear Guidelines: Clear guidelines about when customer complaints need to be brought to the attention of management with executive responsibility
    • Self-Control: Resist the urge to react to the complaint.....Care-front the issues.
    • Initiative: The initiative to lead with the words "I want to help you."
    • Patience: The patience to let someone who has called to complain tells their whole story.
    • Cooling-off Period: Once you have gathered the details from your customer about their complaint, you need to say something like "I am going to start looking into this for you. We will start to investigate the root cause(s)."
    • Planned Response: Your company may not have actually made a mistake, but you need accurate information before you can discuss that with your customer. On the other hand, if your company has erred, you need time to determine what you are going to offer your customer to correct the situation and ensure it doesn't happen again. You will not regain your customer's confidence without solution(s).


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