REV REASON DESCRIPTION ECN # DATE GENERATOR

Modified to meet ISO9001:2000 requirements. Old procedure

G DMS00782 06/09/03 Hemant Buch
QA1601 obsolete.
Release in new format. Added external audit records to the
H DMS00882 09/20/04 Tamas Farkas
Quality Records Matrix
Revised the reference numbers of the required records in
J DMS01007 07/19/06 Tamas Farkas
Table 8.0.

CONFIDENTIAL
This document is the property of Harmonic, Inc and
contains information which is confidential and
proprietary to Harmonic , Inc.. No part of this Quality Records Procedure
document may be copied, reproduced or disclosed to
third parties without the written consent of Harmonic
, Inc..

ISSUED BY: SIZE DOCUMENT NO. REV.

Hemant Buch A QA4204 J
Page 1 of 4

TABLE OF CONTENTS

When printed, document is for REFERENCE ONLY!

Harmonic Inc.
Quality Records Procedure QA4204 Rev J
1.0 PURPOSE AND SCOPE....................................................................................................................2
2.0 POLICY..............................................................................................................................................2
3.0 RELATED DOCUMENTS.................................................................................................................2
4.0 DEFINITIONS...................................................................................................................................2
5.0 RESPONSIBILITIES.........................................................................................................................2
6.0 REQUIREMENTS.............................................................................................................................3
6.1 RECORD RETENTION...............................................................................................................3
6.2 ELECTRONIC QUALITY RECORDS.......................................................................................3
6.3 QUALITY RECORD INDEXING STORAGE AND PROTECTION........................................3
6.4 DISPOSITION..............................................................................................................................3
6.5 IDENTIFICATION.......................................................................................................................3
7.0 PROCESS METRICS.........................................................................................................................3
8.0 QUALITY RECORDS AND RECORD RETENTION.....................................................................4

1.0 PURPOSE AND SCOPE

The purpose of this document is to define the controls needed for the identification, storage,
protection, retrieval, retention time and disposition quality records.

This procedure is applicable to those records that are part of Harmonic, Inc.’s Quality Management
Systems.

2.0 POLICY
Quality records shall be established and maintained to demonstrate conformance to specified
requirements and the effective operation of the quality system. Pertinent quality records from the
subcontractor are an element of these data. Records are maintained by the departments, which
generate them unless procedurally described otherwise.

3.0 RELATED DOCUMENTS

QA4201 Quality Manual

QA4205 Document Control Procedure
Quality Operational Procedures
Quality Instructions

4.0 DEFINITIONS
Record maintenance: Filling in all information required on a form and meeting this procedure’s other
requirements

5.0 RESPONSIBILITIES
The Quality department owns and maintains this procedure and improving it as needed. Quality
records are maintained under the control of the Process Owners or the Document Management
Services center.

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Harmonic Inc.
Quality Records Procedure QA4204 Rev J

6.0 REQUIREMENTS

6.1 RECORD RETENTION

All quality records are maintained for a minimum of 3 years, unless otherwise specified by procedure.
Where agreed contractually, quality records shall be made available for evaluation by the customer or
the customer's representative for an agreed period.

6.2 ELECTRONIC QUALITY RECORDS

All eElectronic quality records that are maintained are stored on the network, which is backed up
regularly by the Network Administrator. Copies of Backups are stored “off-site” to provide added
security.

Backup tapes are retained for minimum of 5 years. Harmonic CEO approval is required before
destruction of these records.

6.3 QUALITY RECORD INDEXING STORAGE AND PROTECTION

All quality records are indexed using a unique identifier that is located on the quality record (e.g., date,
serial number, document number and revision, purchase order number, sales order, etc).

For electronically stored files the actual file name of the record may be different than the document
number or other identification. This is standard practice because of the file naming structure of the
electronic database.

All quality records shall be legible and shall be stored and retained in such a way that they are readily
retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to
prevent loss.

6.4 DISPOSITION

Owners have the authority to dispose quality records after the retention period is met.
Note: In most cases, quality records are maintained in off-site storage. Access to these records is
arranged, but there is a normal delay in recovering the stored materials.

6.5 IDENTIFICATION
The table in section 8.0 lists the most critical quality records used in the quality system. There are
other records that are identified in the process procedures.

7.0 PROCESS METRICS

The number of quality record related nonconformities reported during external audits measures the
success of the record control process. This process shall be reviewed in three years from release or
sooner if the registrar requires it.

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Harmonic Inc.
Quality Records Procedure QA4204 Rev J

8.0 QUALITY RECORDS AND RECORD RETENTION

Retention
Responsible
ISO Record Type Period
Organization(s)
Clause (Generic group) [year]
5.3 Quality Manual, Quality Policy 3 Quality
5.6.1 Management Review: Meeting Minutes and Action 3 Quality
Items (recorded in Corrective Action database)
5.4.1 Company and Department Objectives and Plans 3 HR
7.3 Product Documentation (PLC Records) – Agile, DMS 5 MIS
Back up at offsite.
7.4 Purchase Orders, sub-contractor contracts, AVL 3 Purchasing; Quality
(approved vendor list), supplier surveys.
8.3 Records of any lost, damaged or nonconforming 3 Quality, Operations
customer-supplied material
8.2 Product traceability. Oracle, Vantive, DCS systems. 3 Materials,
Operations, Quality
8.2.4 Inspection and test records 3 Quality,
Operations
7.6 Calibration and Preventive Maintenance records 3 Operations,
Quality
7.5.2 RMA repair/FA (Vantive) 3 Operations,
RMA Logistics
8.5.2 Corrective Action records 3 Quality
8.2.2 Internal and External audit results, and records of audit 3 Quality
related corrective actions
6.2 Records of training 3 Human Resources
7.5 Servicing and warranty records - Vantive 3 Field Services
8.4 Customer Satisfaction and complaint data 3 Quality
8.4 Supplier Performance data and scores 3 Material
8.5.3 Records of Preventive action Quality
7.2.2 Customer Contracts and PO 3 Sales, Legal

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