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PRO-002 Record Control Procedure

This document outlines procedures for record control at a factory. It defines types of records, including hardcopy and softcopy records. It describes responsibilities for record management and procedures for identifying, storing, retrieving, and destroying records. Records must be properly managed and stored for a defined retention period to ensure compliance and demonstrate effective operations. The quality manager is responsible for updating these procedures, while department heads ensure implementation.

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32 views5 pages

PRO-002 Record Control Procedure

This document outlines procedures for record control at a factory. It defines types of records, including hardcopy and softcopy records. It describes responsibilities for record management and procedures for identifying, storing, retrieving, and destroying records. Records must be properly managed and stored for a defined retention period to ensure compliance and demonstrate effective operations. The quality manager is responsible for updating these procedures, while department heads ensure implementation.

Uploaded by

alias brown
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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Document No: -PRO-002 Document Name: Record Control

Revision: 00 Effective Date: 09/01/2017


Context: Procedures Page Page 1 of 5
Document
Document Owners:
Approvers:

REVISION HISTORY
EFFECTIVE REVISION REVISIONS
VERSION
DATE DATE AUTHOR REVISION HISTORY / SCOPE STATUS
NO.
(dd/mm/yyyy) (dd/mm/yyyy)
00 09/01/2017 Effective

1. Purpose

To ensure that records relevant to the company abc Factory Quality Management System
are properly controlled to facilitate retrieval of records when required. It covers the retention
period, storage, protection, retrieval and disposition of all records.

2. Scope

This procedure applies to Quality Management System records (hardcopy and softcopy) at
company abc Factory.

3. Reference

SANS 22000:2005/ISO 22000:2005 Food Safety Management Systems- Requirements for


any organization in the food chain

4. Definitions & Abbreviations

Updating – immediate / planned activity to ensure application of the most recent information.
Department – Section in a particular unit.
PRP - Requirements for Prerequisite Programme.
QOC- Quality and Operations Controller

Record – document stating results achieved or providing evidence of activities performed. A


record is recorded information (created or received) that:

 Is evidence of an entity's operations conformity to requirements and of the effective


operation of the Food Safety Management System and the output of its work, know-
how and the transfer of that knowledge?
 Has an evidential value that requires its retention for a specified period.
Document No: -PRO-002 Document Name: Record Control
Revision: 00 Effective Date: 09/01/2017
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 Can be in any media, is it physical or electronic but must be legible, readily identifiable
and retrievable.
 Demonstrates by means of signatures by authorized individuals that the required
operations/monitoring/verifications had been performed.
 In addition, a record may demonstrate the realization of legal obligations and / or show
a transaction of the business.

5. Responsibility

The QOC is responsible for the updating of this procedure. Respective Heads of Departments
will be responsible for the implementation of the procedure.

Roles Responsibility
company abc Employees  Ensures the retention and destruction of records.
Division / Department Heads  Ensures management of their records.
 Ensures that procedures are in place for the effective
execution of these responsibilities by their staff.

6. Procedure
Records are a valuable component of company abc knowledge base. They are essential to
build, develop and protect a differentiated business for the future. These records are required
to enable company abc to demonstrate, that its divisions/departments have executed their
legal, safety, environmental, fiscal and business responsibilities with all due diligence.

6.1 Procedure Flow Summary


Identity records required Assign staff in-charge Storage of records
Transfer to central Filing Area/Archive Define retention period
Decision on destruction of files Disposal of obsolete files

6.2 Basic requirements

There are various types and requirements of records.

6.2.1 Types of records

There are basically two types of records:


• Hardcopy – physical paper documents (e.g. completed forms, Batch Cards, Expense
Claims, invoices, etc.).
• Softcopy – electronic data or information (e.g. financial figures, etc.).

6.2.2 Record requirements

For all types of records the following basic requirements apply:


Document No: -PRO-002 Document Name: Record Control
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 Appropriate provisions must be made for the safe keeping and maintenance of these
records for the specific duration period.
 Retained records must be kept in an organized manner, to allow easy retrieval and
availability for use or replication.
This ensures that knowledge is built for the future; not repeatedly redeveloped; and increases
the effectiveness of the commercial and technical programmes.

6.3 Characteristics of Records


A record's characteristics are:
 Authenticity – can be shown to be the original version or a true and unaltered copy of
an original version.
 Reliability – can be trusted as a true and fair representation of the transactions or facts
involved.
 Integrity – is legible, complete and unaltered.
 Availability / Usability – can be located, retrieved, presented etc.

6.4 Management of Records


6.4.1 Identification
Records generated within the department are to be identified as evidence of conformity to
requirements and of effective operations. Once the relevant records have been identified, it
needs:
 To be documented in the respective procedures.
 To be legible, and
 To be suitably identified with record or form number (where not electronic).

No scribbles or scratching out is allowed. If any alterations need to be made to any records, a
line needs to be drawn through the error and the appropriate authorization put next to the
correction.

For certain types of information certain criteria need to be followed.


6.4.1.1 Confidential information – For any records identified as being of a confidential
nature, retained records should respect the confidentiality requirements identified from time to
time by Managing Director.

6.4.1.2 Knowledge records – Knowledge records relate to the creation, transfer and use of
intellectual property. They can include records pertaining to any defense / conflicts of
intellectual property rights (IPRs) (passing-off and infringements), trademarks and design
prosecutions.

6.4.1.3 Business/Operational Records - These relate to financial and other business


transactions and human resources management (e.g. invoices accounts, contracts, human
resource data, process record information like OPRP, data/reports).
Electronic business data.
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Once the records have complied with the above, the function head needs to assign relevant
staff within the department to clearly index either by customer name, product type, date, etc.,
quality records as identified. The file name must be clearly identified on each file

6.4.2 Storage and retrieval

6.4.2.1 within departments


 Records which are in use should be at the point of use / data recording / capture. All
files containing the relevant records are to be kept in a designated area to prevent
damage or loss. This can be in the department office or working area. The files need to
be correctly labelled with the appropriate minimum information i.e. name of records,
period of existence, duration of retention period, expiry date of file.
 Only designated personnel are to have access to the storage areas within the
department or central filing rooms or areas.
 All records should be readily available for analysis of data & during audits. Documents /
records stored in archives / electronic media should be easily retrievable.
 Old records should be removed from the point of use and stored till the defined
retention time. All necessary measures are to be taken to avoid damage to documents
and records during the storage period.

6.5 Retention period


There needs to be a defined retention period for all the records used in the relevant
documented procedures. All records will be kept as per defined local legal requirements. If not
otherwise specified by legal authorities / company abc requirements, records should be
maintained for a period of min.5 years.

6.6 Destruction
 Records should be destroyed at their due date, after the retention period, expiry of
defined retention time / validity, except where an alternative arrangement has been
validated by management. The decision to dispose or to destroy the records needs to
be determined by the function head. Request for approval for destruction of records will
be raised by the User/s for the approval by the Function Head.
 Physical records must be destroyed in a controlled manner i.e. they should be shredded
before disposal.
 Data on the media must be deleted before it is sent for disposal.

6.7 Disposal
All records are destroyed by shredding and sent for disposal as normal solid waste.

6.8 Research / Investigations


Where specific records will have to be kept beyond the stipulated retention period for purposes
of research or investigation, the Function Heads in-charge will decide on the period.

7. Records
 None.
Document No: -PRO-002 Document Name: Record Control
Revision: 00 Effective Date: 09/01/2017
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8. Attachments
 None

MD Approval Signature: ------------------------------------ Date: -------------------------------

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