Document number Rev

XXXXX SOP000003 E Sheet 1 of 3

STANDARD OPERATING Title
PROCEDURE Complaint Handling
Confidential & Proprietary

REVISION HISTORY
Rev DCN Change Description Release Date
B 0027 Update SOP format including header and revision history table 1/7/10
C 0045 Updated 5. Reference to SOP000014 was SOP000006, SOP000013 was SOP000007. The 3/29/10
procedures referenced remain the same but the document identifier number changed.
D 0051 Updated to a format similar to other XXXXX quality procedures. No content change. 5/24/10
E 0089 Changed EORL to XXXXX. Added section 3.0 Definitions. Added section on MDR

1.0 PURPOSE

1.1 To describe how XXXXX receives, documents, reviews, and evaluates

complaints.

2.0 SCOPE

2.1 The procedure applies to all employees.

3.0 Definitions

3.1 Complaint- A complaint is any expression of dissatisfaction with a

product or service marketed.
3.2 Complainant- A person or organization making a complaint.
3.3 Customer- The person or institution making the complaint.
3.4 Critical Complaint- A complaint that strongly indicates the safety,
function, efficacy of a product or service may have been
compromised and has the potential to cause a life threatening or serious health
situation.
3.5 Serious Complaint- A complaint that indicates the safety, function,
efficacy of a product or service may have been compromised, but
does not present a life threatening or serious health risk.
3.6 Standard Complaint- A complaint that is neither critical nor serious.
3.7 Justified Complaint- A complaint where the investigation has shown the
complaint to be valid.
3.8 Non-Justified Complaint- A complaint where the investigation has
shown no valid reason for the complaint.

4.0 PROCEDURE
 4.1 A complaint can be information in written or verbal form initiated by a
customer or XXXXX employee. When complaint information is
received by XXXXX, the information is recorded on a Product
Document number Rev
XXXXX SOP000003 E Sheet 2 of 3
STANDARD OPERATING Title
PROCEDURE Complaint Handling
Confidential & Proprietary

Complaint Form (FRM000003-01) by the receiver of the complaint or

their designee. The Product Complaint Form should be completed with as
much information as is available.

4.2 If a product is returned to XXXXX with a complaint, a complaint

investigation will be initiated.

4.3 A complaint log number is issued from the complaint log on our secured
network and added to the Product Complaint Form.

4.4 Available information is recorded on the Product Complaint Form

(FRM000003-01). The information is reviewed by the Quality and
Regulatory department to determine if the complaint is Justified or Non-
justified.

4.5 Justified complaints will be further categorized to Critical, Serious or

Standard based on the above definitions in section 3.0.

4.6 Critical complaints will further be evaluated by our Failure Analysis

SOP000014 and/or Corrective and Preventive Action SOP 000013
procedures.

4.7 Serious complaints will be evaluated by our FA and/or CAPA procedures.

4.8 Standard complaints will be evaluated by the Quality and Regulatory

department to determine if a failure analysis and/or corrective and
preventive action is needed. If a trend of malfunction is noted XXXXX
will further investigate the complaint within the FA and CAPA
procedures.

4.9 An MDR form (Form 3500A) will be sent to the FDA for multiple
Standard, Serious and Critical complaints if the FA or CAPA results deem
it necessary.

4.10 Non-Justified complaints are addressed and filed.

 4.11 A reply to the customer may be prepared describing the results of the
complaint investigation. This reply may be in the form of telephone
Document number Rev
XXXXX SOP000003 E Sheet 3 of 3
STANDARD OPERATING Title
PROCEDURE Complaint Handling
Confidential & Proprietary

contact which shall be documented.

4.12 A final review of the Product Complaint Form is performed by the Quality
and Regulatory department followed by QA/RA signature for complaint
closure.

4.13 Failure Analysis reports and Corrective and Preventive Action reports, as
appropriate, shall be filed and maintained with the Product Complaint
Form indefinitely in the Adverse Event file within a secure area.

5.0 Pro-active Quality Checks

5.1 XXXXX will mail evaluation forms to our customers so they are able to
provide feedback on our products and services.

5.2 XXXXX will hold educational courses 2-4 times per year so
customers can improve their skills and knowledge of our products.