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Procedure Document and Record Control

Document Number: 01-01 Document Owner: Revision Number: Date Issued: Draft Approved By: QUALITY MANAGER

QUALITY SYSYTEMS CO-ORDINATOR

1. Scope This procedure is applicable to all internal Quality Management System documentation as well as relevant external/confidential documentation. 2. Responsibility 2.1. Quality Systems Co-ordinator is responsible to ensure this procedure is implemented. 2.2. All employees need to be aware of the contents of this procedure & comply with the requirements. 2.3. It is the responsibility of each departmental manager/supervisor to ensure that all documents/records remain legible & readily identifiable 3. Definitions 3.1 Document : A written, printed or electronic paper that bears the original, official, or legal form of something and can be used to furnish decisive evidence or information. 3.2 Record: A record provides objective evidence that some type of required systems activity has occurred. This is a completed form. 4. Abbreviations WI: Work Instruction SOP: Standard Operating Procedure QSC: Quality Systems Co-ordinator 5. General 6. Formats & Numbering 6.1 Characterisation Each element within the Quality Management System has been allocated a number as per below: ELEMENT NO: ELEMENT
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 20 Document Control Communication Management Responsibility Continuous Improvement Internal Auditing Control Of Non-Conformances Corrective/Preventive Action Food Safety Occupational Health & Safety Environmental Incoming Material Processing Finished Goods Engineering Quality Assurance Training HR Market Supply Business Continuity Management

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6.2

Numbering

01-01 01-01-01 WI / SOP

Refers to the First procedure under Element 01 First work instruction or Standard Operating Procedure under the first procedure of Element 01 Note: work instruction or Standard Operating Procedure is differentiated by the WI and SOP First form under the first work instruction or SOP under the first procedure of Element 01 First work aid under the first work instruction or SOP under the first procedure of Element 01

01-01-01 F1

01-01-01 WA1

6.3

Formatting All system procedures will be formatted as per Document Control Procedure 01-01. All work instructions & SOP formats are available & standardised as per blank templates.

7. Creation /Change of a Document or Record 7.1 7.2 7.3 7.4 Any employee can request a creation, change or amendment of a document/Record but only the Document Owner can authorise it. The writer of a document can be the most involved person in the scope of the document or the document owner. Any new document/record can be used for a month under a TRIAL period thereafter it must be finalised and forwarded to the QSC for review. Document/Record Change can be initiated by two methods : Hardcopy- highlight document number, make applicable changes on the document (attach other notes). Have document signed by the doc owner & submit to QSC. Electronic make applicable changes & deletions in different colours. Email to the doc owner who will forward to the QSC. The Quality Manager & QSC will review the changes to ensure compliance integrity is not compromised.

7.5

8.

Approval and Release 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.9 Once created or modified, a document/record must be approved by the respective head of department before it can be issued by the QSC. Approvals are provided via email. The QSC will save the approval emails within k:/drive as a formal record. Following the formal approval, the document is stored within the K:/Drive QMS Docshare. The QSC will update the master document register. The Old document is moved into the obsolete folder with the old revision number included in the title. The QSC will issue the new / revised document/record to the respective people via email. The QSC will save the issue emails within k:/drive QMS Docshare as a formal record of Approval.
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8.10

When new or revised documents/records are issued the owner is responsible for destroying obsolete copies.

9.

Document Review All procedures/work instructions/records shall be reviewed during the Internal Audit procedure process & reference made to the relevant documentation.

10. Storage and Retrieval of Documents/Records 10.1 All system documentation, policies, procedure, work instructions, forms & work aids Can be readily available on the server network directory Group Dir/K/Docshare/Quality Management System. 10.2 All documents & records must be stored securely & protected from damage, loss & miss-appropriation. 10.3 All records are stored in a manner whereby it is easily identified, & easily retrievable whether in hardcopy or electronic 10.4 The department will display a hard copy of the Record/Document Display List 0102 F1 which describes the easy retrieval of records. 11. Distribution of documents: 11.1 A document can be printed by any employee but is only valid on the day of print, thereafter the document becomes uncontrolled. This is noted at the bottom of each page of the document. Documents to be displayed or stored for longer than a day can only be authorised by the head of the respective department. The Document Issue File is to be completed by the head of department before a document can be released for display. All procedures, work instruction, work aids & SOPs that are displayed will contain a CONTROLLED COPY stamp in green ink. All displayed documents shall be recorded on the Document Distribution Register by the QSC.

11.2 11.3 11.4 11.5

12.

Record Retention/Disposition

12.1 12.2

The minimum record retention periods will be recorded on the Document Master list. Records which are older than the minimum retention period may either be kept securely or shredded. 12.3 Records shall be made available for audit & inspection purposes.

13.

Documents of External Origin 13.1. External documents include but are not limited to permits, licences, MSDSs, COAs, legal requirements e.g. Acts, bylaws etc. All hard copies of external origin shall be recorded on External Document Register. Suppliers will be responsible for the issuing of the latest revision of all their documents. 13.2. Electronic Media Computerised back up files of all the latest revision quality documents are kept in a safe. The IT Department will back up files weekly. Access to edit the System Documentation is controlled and accessible only by the Quality Department and Production Executive. The IT Department will ensure that surge and virus protection is applied and maintained on the companys computer systems. 13.3 Material Specifications These documents whether in hard copy or electronic will be secured in the respective Managers offices. Work Aids may be generated to assist in production and product conformance confirmation.
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Brand Technical Manuals: Governance Office Supplier Specifications: Governance and Incoming Goods Lab 13.4 Legislation Control 13.4.1 The total Current South African Legislation requirements are listed and all department heads (Field of expertise) determine the requirements applicable to their department. These are evaluated on a need or like to have basis. 13.4.2 A Reputable Electronic Legislation provider shall be nominated to supply the requirements as determined by the business. 13.4.3 A list of the relevant Acts and Regulations shall be available on the Brandhouse Intranet. 13.4.4 Export Products legislation is handled & communicated by the Export Team that is based in Cape Town. 13.4.5 The Service Provider shall provide updates and amendments during the subscription period and a complete update shall be supplied on an annual basis. 13.4.6 Updates or amendments shall be loaded onto the intranet and the Governance Manager shall alert the business to changes or updates. 13.4.7 Accountability for compliance and communication with Legislative bodies is split into areas of Responsibility. The Company Directors and the Legal Department is responsible for ensuring that the business is compliant. 13.4.8 The Supply Governance manager is responsible to ensure that all SHEQ applicable legislation is implemented. 13.4.9 At the Manufacturing Facility the Legislation & standards shall be summarised for easy implementation and gap analyses. Requirements shall be included in the relevant Training Material. 13.4.10 Consequences/Penalties for non- compliance to the Relevant Acts shall be determined at the time of the specific audit and the potential for these shall be described in the relevant sections of the Quality Management System. 14. Document Register 14.1 14.2 14.3 All procedures, work instructions, works aids & forms will be recorded on a Document Map/Register for easy of retrieval of documents. All displayed documents shall be recorded on the Document Distribution Register. All external documents are recorded within the External Document Register.

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DOCUMENT/RECORD CONTROL PROCESS FLOW


DOCUMENTS

Policies Procedures Work Instructions Standard Operating Procedures Work Aids Forms

YES

New?

NO

Create document

Edit document, changes highlighted in red NO

NO Document approved by HOD Document approved by HOD

QSC: Record of changes saved.

YES

QSC: Record of approval saved.

System review by QSC

System review and Update by QSC

Document approved by HOD


-

YES

QSC : Record of approval saved.

Control of document by QSC

Document Issue by QSC

QSC: Record of Issue saved.

Remove All Obsolete Documents

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Document & Form References Document No. 01-01 F2 05-01 01-01 F1 01-01 F3 01-02 F1 Retention Period N/A N/A N/A N/A N/A

Document Name Master Document Register Internal Audit Procedure External Document Register Document Distribution Register Document Issue Form

Retrieval

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