Training SOP Complaint Handling for Importers Distributor Retailers of by robyniscrazy

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									                    Training SOP-802
                   Complaint Handling
                           for
  Importers-Distributor-Retailers of Pointe Conception Medical
                        Branded Product

                                     and

  Private Labeled Manufacturers of Pointe Conception Medical
                     Contracted Product




   What are we trying to accomplish
                here?


Pointe Conception Medical, Incorporated is a medical device design and
manufacturing facility.
As such, Pointe Conception Medical is highly regulated by several regulating
bodies and standards of performance:

93/42/EEC Medical Device Directive [Covers medical devices in the European
Union]

21 CFR 820 FDA Quality System Regulation [Covers medical devices in the USA]

Canadian Medical Device Regulation [Covers medical devices in Canada]




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   Each of these regulating agencies
        have requirements for

               COMPLAINT HANDLING
                       for
                 MEDICAL DEVICES




         Let’s look at some definitions



MANUFACTURER:
The natural or legal person with responsibility for the design, manufacturer, packaging
and labeling of the device before it is placed on the market under his own name,
regardless of whether these operations are carried out by that person himself or on his
behalf by a third party.


PRIVATE LABEL MANUFACTURER:
The company that appears at the manufacture but does not itself produce the device.


OEM CONTRACTOR:
The company that produces the finished device for a Private Label Manufacture, and
whose name does not appear on the device.




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         Let’s look at some definitions



IMPORTER-DISTRIBUTOR-RETAILLER of PCM branded product:
A company who imports, distributes or retails PCM Branded Product

PRIVATE LABEL MANUFACTUER of PCM contracted product:
A Private Label Manufacturer [their name appears on the product] of PCM Contracted
Product [Product which has been designed and manufactured by PCM].

COMPLAINT:
Any written, electronic, or oral communication that alleges deficiencies related to the
identity, quality, durability, reliability, safety, effectiveness or performance of a device
that has been released for distribution.




         Let’s look at some definitions


SERIOUS INJURY:
An injury that is life threatening, or results in permanent impairment of a bodily function,
or necessitates medical or surgical intervention to preclude permanent impairment of
bodily function or permanent damage to a body structure.
CORRECTIVE ACTION:
Action taken to resolve and eliminate the causes of an existing non-conformance or
defects in order to prevent recurrence.

PREVENATIVE ACTION:
Action taken to eliminate the causes of potential non-conformance or defect in order to
prevent occurrence.
MEDICAL DEVICE REPORTING:
Reports to regulating agencies of Adverse Medical Events which meet reporting criteria.
These are, in general, substantial medical events involving serious injuries or death.




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           Let’s look at some definitions



FIELD CORRECTION:
Device is repaired, modified, destroyed, et cetera, without physical removal of its point
of use to another location.

FIELD REMOVAL:
Device removed from point of use to another location for repair, modification,
destruction and et cetera.

RECALL:
Device is recalled from the field.




            What are the GENERAL
         REQUIREMENTS for Complaint
                  Handling?
COMPLAINT HANDLING REQUIREMENTS:

•All complaints are processed in a uniform and timely manner.

•Complaints are evaluated to determine whether a Medical Device Report is necessary

•Complaints shall be investigated and evaluated as required.




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    What are the GOALS for Complaint
                Handling?

COMPLAINT HANDLING GOALS:

•Ensure a strong feedback loop from CUSTOMERS to Designer and Manufacturer.

•Prevent re-occurrence of Complaint through PREVENATIVE and CORRECTIVE
ACTION for any relevant COMPLAINT

•Disposition of any field units which may also contain COMPLAINT; Field Repair,
Repair, Recall, et cetera.




     What is YOUR ROLE in Complaint
               Handling?

YOUR ROLE IN COMPLAINT HANDLING:

•Evaluate any complaint from your direct customer [PCM does not have any direct links
with your customer]

•Determine if the COMPLAINT WARRENTS ACTION FROM POINTE CONCEPTION
MEDICAL.
     •IF NOT; resolve the complaint between you and your customer.

    •IF SO; contact PCM Customer Service to generate a PCM Complaint Form
    [Form 835]




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       What is YOUR ROLE in Complaint
                 Handling?
•Working with PCM
Customer Service
to Generate a
Complaint Record
for analysis by PCM

•Working with PCM
Customer Service
to resolve the
complaint following
analysis




Data YOU must supply for Complaint Handling?
1.   Customer NAME [Your NAME, you are our customer]
2.   Customer ADDRESS [Your ADDRESS]
3.   Customer CONTACT INFORMATION [Daytime phone, FAX, E-mail]
4.   Date of Problem Occurrence [When did the issue occur which requires a
     complaint?
5.   Description of the Problem/Failure [NOTE: A good description is essential to
     resolution]
      • No Picture
      • Bad Picture
      • Broken
      • Explain the failure and why it is a complaint.
6.   Was a Death or Serious Injury involved? [Describe]
7.   Was Medical Intervention Required? [Describe]
8.   Source of Complaint
      • Device Part Number
      • Device Serial Number

PCM Customer Service will guide you through the form, but having this
  information available for Customer Service will facilitate the Complaint
  Processing.




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              HOW TO CONTACT PCM
               CUSTOMER SERVICE
BY PHONE:

Monday through Friday 9:00 am to 5:00 pm; Pacific Standard Time
805-964-8104 Extension 120

BY E-MAIL:

customerservice@pc-medical.com

ON THE WEB:

http://www.pc-medical.com   [Customer Service Tab]




                               END
                              SOP-802

   Training for Complaint Handling




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