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control of Record Rev C
control of Record Rev C
control of Record Rev C
DOCUMENT NUMBER CLASSIFICATION DOCUMENT LEVEL REVISION NUMBER ISSUE DATE PREPARED BY APPROVAL
TECHNICAL ADVISORY MFG
GL-WFT-SC-L4-26 CONTROLLED L4 Process Realization C 11 May 2016
COMMITTEE FOR MFG APPROVAL BOARD
TABLE OF CONTENTS
Part Description
1.0 Purpose
2.0 Scope
3.0 Responsibilities
4.0 Procedure
4.1 Identification of Records
4.2 Storage of Records
4.3 Protection of Records
4.4 Records Retrieval
4.5 Records Retention
4.6 Destruction of Hard Copy Records
5.0 References and Records
6.0 Document Change Record
1.0 Purpose
The purpose of this procedure is to define the controls required for the identification, storage,
access, protection, retrieval, retention time, and destruction of records.
2.0 Scope
This procedure applies to all records required by the latest revision of ISO 9001 standard and the
API specification Q1, applicable API product specifications, applicable industry standards and
where applicable, contractual customer requirements.
3.0 Responsibilities
The global quality assurance management group is responsible for ensuring this procedure is
maintained. The site top management and the site management representative are responsible
for ensuring this procedure is implemented, understood, complied with, and communicated.
Department managers are responsible for the maintenance of records specific to their department
and to ensure that personnel within their area of responsibility are familiar with and adhere to the
requirements of this procedure.
4.0 Procedure
4.1.1 Records are to be identified by responsible departments to facilitate retrieval and shall include,
but are not limited to the following:
Type of Record
Employee Training
Job Descriptions
Management of Change
Preventive Maintenance
Outside Order
Purchase Order
Quality Plans
Storage Assessment
Take 5 Assessment
Test Reports
Training Certificates
4.2.1 All active and inactive records shall be maintained by the designated department responsible for
those records.
4.2.2 Hard copies: Records stored in inactive files shall be stored in a suitable manner to ensure
records remain legible, readily retrievable, protected and identified by:
4.2.3 Electronic: Archived inactive records are stored in a suitable media with access controlled by the
designated department to prevent unauthorized access. If hard copies are scanned into electronic
media, they are to be legible and identifiable.
4.3.1 Active records shall be maintained in an appropriate location to ensure their protection from
damage or loss.
4.3.2 Inactive records shall be stored in a suitable environment to ensure their protection against
damage, deterioration, or loss.
4.4.1 Records shall be filed with consideration given to ease of retrieval while safeguarding the physical
condition of the records. Records can be either electronic or hard copy.
4.5.1 Records related to the Quality Management System shall be retained for a minimum of ten years
or as required by customer, legal, and other applicable requirements, whichever is longer.
4.5.2 Legal record retention requirements are specified on the records retention schedule located on
the intranet. The retention schedule and disposal can be accessed by using the following path:
4.5.3 Quality records not listed on the Records Retention Schedule on the intranet shall be kept in
accordance with section 4.5.1
4.5.4 Each site shall identify records requiring additional applicable product specification requirements.
4.6.1 The method for discarding or destroying hard-copy records may vary from placing non-sensitive
records into the general office recycle bins or destroying records through the shredding process
for sensitive material that is confidential or proprietary in nature.
4.6.2 Disposal of records, request for empty boxes, request for one or more labels, or to send boxes
offsite, shall be performed in accordance with the Records Management SharePoint Site, which
can be accessed by using the following path:
• ISO 9001
• API Q1 Specification
• Applicable API Product Specification
• GL-WFT-SC-L4-26 Control of Records Procedure
5.2 Records
Revision Effective
Responsible Parts Affected Change Description
Number Date
Approval Board
A 11 May 2016 All New Standardized Global Procedure
for Mfg
Approval Board
B 11 Apr 2017 4.5.1 Changed from five to ten years.
for Mfg.
-Modified the links in section 4.5.2 and
4.6.2 to reference the new records
4.5.2 retention schedule and newly developed
Approval Board
C 15 Dec 2017 4.6.2 Records Management SharePoint site.
for Mfg.
5.1 -Modified section 5.1 to remove
references that were listed and were not
referenced on the procedure.