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1. Purpose

This procedure establishes the system for identification, collection, indexing, access, filing,
storage, maintenance, and disposition of quality records.

2. References / Attachments

3. Definitions

3.1 Records: Documents that are used for product manufacturing, product acceptance and the
administration of the quality system.

4. Responsibilities

4.1 The Quality Manager is responsible for the development and maintenance of procedures for
controlling quality records.

4.2 Department managers are responsible for quality records under their control as specified in
this procedure.

4.3 All employees are responsible for the requirements in this procedure to the extent specified.

4.4 The designated internal auditor is responsible for periodically monitoring the activities
associated with control of quality records.

5. Procedure

5.1 Identification:

Quality record types are identified in Quality Procedure QP 16-1.A.

5.2 Collection:

The manager, or designee, of the responsible department, as specified in QP 16-1.A, is

responsible for collection of the quality record(s).
5.3 Indexing:

Quality records will be indexed by job number, record number, or other identifier, as specified by
the manager of the responsible department.
Records will be indexed in such a manner as to be easily retrievable.
5.4 Access:

It is recommended that access to quality records be limited to personnel authorized by the

department manager of the responsible department.
The Quality Manager, and internal auditors have unlimited access to all quality records.

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5.5 Filing and Storage:

Quality record storage areas/ cabinets will be clearly identified, with a unique identifier, by
Document Control. Storage Area identifier numbers and location are specified in QP
16-1.A.
Offsite storage and the computer server will be given identifier numbers, but will not require the
identifier number to be on the facility or server.
The records stored in each record storage area/ cabinet are identified in QP 16-1.A.
Quality records will be filed and stored in dry, clean storage areas.
Active Quality Records will be stored in metal filing cabinets for easy access.
Inactive Quality Records will be stored in metal filing cabinets or filing boxes in designated
storage areas.
Cabinets and storage containers may be labeled to specify contents, but this is not a
requirement as contents are specified in QP 16-1.A. When contents are customer
specific, the containers will not be labeled in areas subject to audit by customers.
5.6 Maintenance:

Department managers are responsible for maintenance of quality records as specified in QP 16-
1.A.
5.7 Disposition:

Quality records which have met or exceed the retention period requirements may be disposed
of, under the direction of the Quality Manager.
Quality records being disposed of will be shredded prior to disposal.
5.8 Electronic Records:

Quality records that are maintained as electronic files are backed-up as specified in QP 05-1.
Back-up tapes are maintained in a secure location outside of the manufacturing facilities per
CWP-05-02.
All other requirements in this procedure apply to electronic media records.
5.9 Record Retention:

All quality records are maintained on file for ten (10) years Except:
 Audits-Two (2) years after audit
 Validations- Ten (10) years after last day of production
 Training- Ten (10) years after last day of employment
 Equipment Records-Ten (10) years after last day in production
 Inspection Results
 Certificates of Conformance
 Sales orders
 Purchasing Orders

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 Supplier Records
 Customer Feeback/Complaints
 Management Review 5 years
 Incoming inspection results 3 years minimum
 CAPA
 Malfunction Reports

5.10 Record Entries

All entries on quality records must be made in Blue or Black ink.

The use of materials, such as white-out or correction tape, to cover information or correct errors
is not allowed, and these items are prohibited from manufacturing and quality areas.
No entries will be made with pencils.
Post-it notes are not considered an official or permanent record. Any notices requiring posting
must be typed, signed, and dated.
Manual changes/corrections to original information must be made by drawing a line through the
original entry to maintain legibility of the original information.
The individual making a change will initial and date the correction.
Changes/corrections to records will be made only by personnel authorized to maintain those
records.
The individual making a change or correction is responsible for any action related to the change.
All lines/ blocks on records must have appropriate entries. In cases where an entry is not
required, the initials “N/A” will be entered to indicate that an entry is not required.
Record entries must be made by the individual performing the operation or test only. Entries
made by individuals, other than the person performing the operation/ test are
considered fraudulent and subject to disciplinary action.
Operations which require an entry for each individual piece manufactured or tested, must have
the entries made at the completion of the operation/ test for each individual piece.
Exceptions:
5.10.1.1 Status tags used to identify inventory may be used to track inventory count
changes.
5.10.1.2 Changes to the quantity entry on the status tags used for inventory may be
made without the individuals initials and date of change.
6. Records

6.1 Record indexes are the only records associated with this procedure.

6.2 Record indexes are kept electronically as lists.

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7. Revision History

Approval Effective
Revision ECO Number Reason for Revision
Date Date
A 9 New Issue

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