SOP-Control of Documented Information

SOP FOR CONTROL OF DOCUMENTED INFORMATION.
Revision History
VER # Date DCR # Nature of amendment
1.0 1-Mar-2019 N/A First Issue
Author
Name: <Name Here>
Designation: <Position Here>
Signature:
Review
Name: <Name Here>
Signature:
Approval
Name: <Name Here>
Signature: Effective Date: <Date Here>

1. Purpose
The procedure for control of documented information provides guidance for managing documented
information being generated in the organization or being acquired externally in an effective
controlled manner.
2. Scope
This procedure is applicable to all the functions of Organization and following activities are covered
in this procedure related to management of documented information;
- Document review and approval

- Development of new documents
- Revision process and control of obsolete documents
- Distribution
- Retention and disposal
This procedure covers two types of documented information maintained in the company:
- Documents which support an effective operation such as policies, procedures, manuals,
process maps, plans etc.
- Records which provide the evidence of conformance such as production reports,
inspection results, monitoring data, audit reports etc.
3. Responsibilities
Functional Heads/Managers/Supervisors are responsible for;
- Implementation of this procedure in their relevant areas.

- Maintaining “List of Documents” for the documents being used in that area.
- Maintaining a “List of Records”.
4. Procedure
4.1 Document Preparation, Review and Approval
4.1.1 Functional heads ensure that all documents (whether new or revised) are approved by
concerned authority before they are put into practice.
4.1.2 Documents to be used in the company are prepared, reviewed and approved according to
authorities given below in the table.
Authority Matrix for Control of Documented Information
Position Authority
General Manager Review and approve all documents falling under management
system.
Department/ Function
Create department level documents, policies or procedures.
Head
4.2 Document Identification

All the documents generated in the company should be clearly identifiable using the following
information in header/footer:
- Identity of the organization (Logo, Name etc.)

- Adequate title for the document
- Document History (Manual, SOP’s, Policies Only)
- Document Number
- Version #
- Date
4.3 Distribution of Documents
4.3.1 This method is only applicable to documents such as Policies, Procedures, Instructions, etc.
4.3.2 All issued documents among staff members should be marked as “Controlled Copy”.
4.3.3 Each functional head should maintain a “List of documents” which contains the document
code, versions, issue dates and distribution of the documents.
4.4 Control of External Documents
4.4.1 External Documents should be identified by their code if provided by the originator. In case
the document does not bear any code; then it should be identified by nomenclature.
4.4.2 External origin documents should also be registered in the “List of Documents”.
4.5 Records Management

4.5.1 Functional Heads/Supervisors should maintain a “List of Records” for their department or
function. All the records generated or maintained in relevant functions should be listed in
the list which contains;
a. Document Code
b. Name/Identification
c. Responsible Person
d. Location/File No
e. Retention Period
4.5.2 The retention period of records is established for certain periods during which the record
may be required for study or verification. Retention period should be defined based on the
following factors:
a. Frequency of record generation
b. Product life
c. Contractual, legal
4.5.3 Retention periods should be defined in the “List of Records”.

4.6 Storage and Protection
4.6.1 All documents and records should be maintained in a dry and safe place where risk of
physical damage is minimum.
4.6.2 Documents and records in soft form should be regularly backed-up to ensure availability of
critical data in case of any accident or incident leading to loss of such data.
4.6.3 All records are held secure and in confidence and only responsible persons are authorized to
access them.
4.7 Document Change Process

4.7.1 If a document is required to updated or modified, SOP for Change Management should be
followed.
5. Related Documents and Records

i. SOP for Change Management
ii. List of Documents
iii. List of Records

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SOP FOR CONTROL OF DOCUMENTED INFORMATION.

VER # Date DCR # Nature of amendment

1.0 1-Mar-2019 N/A First Issue

Signature: Effective Date: <Date Here>

- Document review and approval

- Implementation of this procedure in their relevant areas.

4.2 Document Identification

- Identity of the organization (Logo, Name etc.)

4.5 Records Management

4.5.3 Retention periods should be defined in the “List of Records”.

4.7 Document Change Process

5. Related Documents and Records

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