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1.0 Purpose
The purpose of this procedure is to define the system of control over the identification,
generation, updation, review and approval prior to issue and maintenance of all the documents
and data relating to the requirement of the company's quality system. It also describes
procedure for making changes / amendments to the documents and ensuring that the latest/
current issue and revision of documents are in use at appropriate location throughout the
organization. Another purpose of this procedure is to ensure that the documents remain legible
and readily available.
2.0 Scope
2.1 This procedure applies to the following documents:
FSSC 22000 & BRC Manual Standard Formats
Quality/System/ Product Safety Documents of External Origin.
Procedures
Work Instructions /Standard Exhibits, Standards (Internal & External) and Data
Operating Procedures (Including Customer Specifications)
Quality Plan and Inspection and Test Plan, Specification Sheets, etc.
3.0 Responsibility
All documentation essential to the accomplishment of the work are controlled and maintained
properly.
The responsibility for document review, approval, issuance, modification and maintaining master
list is as under:
Table – 1 Responsibility Matrix For Documents
Responsibility
Type of Document Maintaining document
Document Review, Modification
Master list and issuing as
and Approval
per distribution
1. BRC Manual Top Management Product Safety Team Leader
2. Quality/System/ Product
Product Safety Team Leader Product Safety Team Leader
Safety Procedures
3. Quality Plan Product Safety Team Leader Product Safety Team Leader
4. Applicable Standards
MR for Follow-Up Product Safety Team Leader
(External)
5. Formats, Work Instructions
6. Exhibits, Reference Top Management / MR /
Documents Functional Heads in Their Product Safety Team Leader
7. Specification Sheets and Applicable Areas
Data
8. Customer Specification
Top Management / Product
and Documents of External Product Safety Team Leader
Safety Team Leader
Origin.
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Table – 1 Responsibility Matrix For Documents
Responsibility
Type of Document Maintaining document
Document Review, Modification
Master list and issuing as
and Approval
per distribution
Note: - Master copy of all the documents are kept with Product Safety Team Leader, who is
authorized to issue the same.
4.0 Description of Activity
4.1 Document Generation and Approval
4.1.1 All the necessary documents are prepared for effective implementation of quality system. The
personnel nominated in respective areas are mainly responsible for identifying the need for new
documentation in their respective areas. It is reviewed and approved by authorized person as
per details given in Para 3.0.
4.1.2 The authorizer may involve concerned department’s personnel in reviews. The draft documents
are circulated to concerned person for their comments, wherever required. All comments are
compiled and included as required in the final document.
4.1.3 Reviewing personnel or organization have access to pertinent information on which to base their
review and approval.
4.2 Document Codification, Issue and Distribution
4.2.1 The numbering system used for easy identification of Quality Manual, Quality Procedures, Work
Instructions, Exhibits and Formats is as described in E/SYS/01. Each copy of approved Quality
Manual and Quality Procedures is given a unique copy number given to Copy Holder. The other
documents like Exhibits, Specifications and Data are given a unique identification number
decided by Product Safety Team Leader / Functional Heads in their respective areas and they
put effective date of implementation on it. It may not follow our new codification system because
numbers are given in past and existing for such documents.
4.2.2 Product Safety Team Leader is responsible for issue of controlled as well as uncontrolled copies
of the Quality Manual, Quality Procedure, and Work Instruction, Specifications after affixing
Controlled Copy” or “Uncontrolled Copy” stamps, respectively, on every page. If Xerox copy of
controlled copy is taken then it is again stamped for controlled copy and is distributed as per
distribution list.
4.2.3 Up-to-date record of master list of documents with latest issue no. and effective date of
implementation is maintained by Product Safety Team Leader for all the tiers of documents,
including documents of external origin. The same is made available as a ready reference, in the
MR’s document file, to all the personnel in order to preclude the use of superseded (obsolete)
documents.
4.2.4 For the external or national reference standards used in the quality and Product safety systems,
best possible efforts is made by the Product Safety Team Leader to procure the latest revisions
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of these by keeping in touch with the vendors who provide these external standards or
authorized government offices at least once in a year.
Product Safety Team Leader is responsible for providing the reference standards used for
quality and Product safety systems including their latest issues if requested by the concerned
person. He keeps a record of the same. For international standards used by the company,
Product Safety Team Leader makes correspondence with the publisher / agents for the same
and updates at least once in a year.
All the national / international standards used in the company are checked for their latest
revision by contacting local office of publishers once in a year.
4.2.5 It is the responsibility of the Product Safety Team Leader / concerned person to make the
pertinent latest revision of document available at all locations where operations related to the
effective functioning of the quality and Product safety systems are performed. It is the respon-
sibility of the authorized holders of the respective documents to keep them safe. The documents
are given to the authorized person as per distribution list maintained by the Product Safety
Team Leader.
4.2.6 It is the responsibility of the Product Safety Team Leader and Functional Heads that all the
documents used and reviewed by them remain legible, readily identifiable and retrievable when
required. The documents are identified by name and / or document no.
4.2.7 Product Safety Team Leader and respective Functional Heads ensure that uncontrolled copies
of any documents are marked "uncontrolled copy" and it is issued to other persons on request.
Holders of "Uncontrolled Documents Do Not Receive Revision". All the other copies of
documents, except formats, are stamped as "Controlled Copy” on all Pages by the Product
Safety Team Leader and issued to the persons as per distribution list with copy number, if
required. All the formats used in the company are controlled copy, so no stamp of controlled
copy is required for the formats. As soon as any document becomes obsolete, the stamp of
"Obsolete" is put and it’s not taken for routine use.
4.2.8 Controlled copies issued to external parties are transmitted via change note for revision of
document or under a covering page.
4.3 System of Writing Documents
4.3.1 Quality Procedure is written as per header and footer shown in Annexure-II. The contents of the
procedure cover the sub-headings given in above-mentioned Annexure-II, wherever applicable.
All procedures are approved by authorized person by signing on the cover page.
4.3.2 The Work Instruction has header and footer.
4.3.3 For Exhibits and Formats, titles may be given on the document with necessary identification.
The master copies of formats are having document number and issue number that is maintained
by the Product Safety Team Leader.
4.4 Modification of Documents
4.4.1 All personnel can report to the Product Safety Team Leader / Concerned Functional Head for
the need of new documentation or changes to the existing documentation.
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All such document change requests are made by raising Change Note. The Product Safety
Team Leader reviews changes. If the request is denied, the change note is returned to the
initiator along with reason for denial. Verbal discussions are clarified as soon as possible. A
corrective action form also identifies the need for new documents or changes to the existing
documentation. If the change requested, is accepted, Product Safety Team Leader does
necessary changes and makes necessary follow-up for approval. Also, Product Safety Team
Leader changes the supportive documents, if changes affect other documents.
4.4.2 Revised documents are subject to the same approvals and controls as per the original one. In
case of amendments to the particular page, the next issue no. is given by adding suffix to issue
number. In the case of BRC Product Safety Manual Issue no. 1.0 becomes 1.1. After more than
nine amendments in the single page the whole issue of BRC Product Safety Manual is revised
with new issue number. Such revised documents are issued with approved change note.
4.4.3 For BRC Product Safety Procedures, Work Instructions, Exhibits and Formats, next issue no. of
whole document is given, for example 01 becomes 02, and all the pages of the documents are
revised except if decided by approving authority for documents having more than 10 pages. In
such cases the documents are revised by changing individual pages, if need is identified by
approving authority as per system described for Manual (Para 4.4.2).
4.4.4 The text affected by the latest review change are identified by an asterisk (*) or suitable marking
near the right / left hand margin. Also next issue no. (Revision status) is given to such
documents.
4.4.5 Obsolete documents are destroyed (unless otherwise specified in the change note) by the
Copyholders. One copy of the obsolete documents, where required, is maintained in files by
Product Safety Team Leader for future reference and stamped or noted as OBSOLETE.
4.5 Control on External Documents, Customer Documents and Specifications
4.5.1 All the external documents, including customer documents and specifications are controlled as
per the below mentioned procedure:
All such external documents received from outside are forwarded to the Product Safety
Team Leader.
Product Safety Team Leader reviews the documents and puts stamp of reviewed on the
backside of document. Also, he puts another stamp of “Master Copy” on the backside of
document.
Product Safety Team Leader writes proper identification number and date also, if not
written by the customer / External Standards.
After that he enters the details of the documents in the Master List of the documents.
Product Safety Team Leader further distributes it to the concerned persons in Company
after affixing stamp of “Controlled Copy” on it.
He enters the details of the distribution in the distribution list as per the copies distributed.
Product Safety Team Leader maintains master list as well as distribution list of all such
documents of external origin and updates the master list as soon as any revision is
received in such documents.
If required, “Obsolete” copies of the documents of external origin are maintained with the
Product Safety Team Leader for future reference.
Prepared And Approved By Signature Page
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4.6 Control of Electronic Data
4.6.1 Computer is used in the company for maintaining records, documents and other purposes.
Proper master list is maintained, where required, for amendments done in-house in electronic
documents kept by the company.
4.6.2 Approver confidentially identifies documents and data stored in electronic form and it is
controlled by access code.
4.6.3 Once in a month, or as identified by user, user takes the backup. Hard copies of all the
necessary documents / data / records are stored in computers.
5.0 References
5.1 PRO/SYS/04 Procedures for Control of Quality Records.
6.0 Enclosures
6.1 Annexure - I Numbering System for Documents.
6.2 Annexure - II Form for Writing BRC Product Safety Procedure.
7.0 Formats / Exhibits
7.1 F/SYS/01 Master List cum Distribution List of Documents.
7.2 F/SYS/02 Change Note.
7.3 E/SYS/01 Codification System
Annexure – I Numbering System for Documents
A. Numbering System for BRC Quality System Procedure
BRC Quality system procedures are numbered as under:
PRO/XXX/++
PRO Stands for Procedure.
XXX Stands for the abbreviation of particular department for which procedure is prepared
and is described in E/SYS/01.
++ Sands for serial number of procedure against particular department.
Thus PRO/SYS/01 refers to first System Procedure of BRC Product Safety Management
System.
B. Numbering system for work instructions / exhibits / formats
Documents are given number reading: * /xx/++/$$
(I.) * W = Work /Test /Operating Instruction, F = Format, E = Exhibits.
(II.) XX Written in alphabet and stands for the name of department; as described In
E/SYS/01.
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(Iv) ++ Figures in numerical is a running serial number of document used in Company for
the particular category of document and the work area.
(V) $$ Figures in numerical / alphabet; optional and used by users as per requirements.
Annexure – II Form for Writing System Procedure
No. PRO/+++/XX
Department Punyam Packaging Inc. Issue No. 01
SYS
Procedure Date 01.09.2019
Title
1.0 Purpose: This section clearly defines the intent and objective of the procedure.
2.0 Scope: This section outlines the area, department or personnel to which the procedure
is applicable, as well as extent of application.
3.0 Responsibility: Person responsible / department head involved in follow-up of the
procedure.
4.0 Description of Activity: It gives details for what is to be done, when, where and how it
is done; what materials, equipment are used, and controls to achieve the desired
objectives as defined under purpose.
5.0 Reference: This section specifies any documents referred to in the procedure or the
documents whose requirements are to be implemented as a result of activities
described in the procedure.
6.0 Enclosure: Give the title(s) of enclosure(s) enclosed with the procedure.
7.0 Formats / Exhibits: (Write Exhibit, if any exhibit is included in the procedure). Give title
and document number if used for follow-up of procedure.
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