DOCUMENT CONTROL

3

Note

This type of table reminds personnel to ensure that they are using the most up-to-date version of any document and can be placed at the front of the binder.

2.5 DOCUMENT CONTROL

OVERVIEW  

Your quality manual and ALL do cumen ts

1. Laboratory management shall define, document and maintain procedures to control documents and records. Documents and records may be maintained and stored on any appropriate medium that maintains its integrity (Paper or electronic).

in your QMS will be considered controlled documents (ref: Appendix 10–document control checklist). Changes to documents must be controlled to prevent irrelevant and unauthorised changes being introduced. The standard requires that documents shall be reviewed and approved by the original reviewer(s) or by other authorized staff thoroughly conversant with the background information on which the original documents were based. In order to ensure that documents can be issued and withdrawn efficiently and accurately, a control mechanism - such as a MASTER LIST - should be developed to record and identify documents, their revision status and the document location. Requirements for document control are as follows (ref: ISO 17025 Clause 4.3):

2. Authorized documents shall be available at all locations where operations essential to the effective functioning of the laboratory are performed (e.g. within easy reach of the work areas in the laboratory).

3. All documents issued to laboratory personnel as part of the quality management system shall be reviewed and approved for use by authorized personnel prior to us e.

4. A MASTER LIST, also referred to as a DOCUMENT CONTROL LOG, that identifies the current valid revisions and their distribution, must be maintained. An example of a master list is provided in Figure 18 below.

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

Page 43 of 85 Figure 18 Example of Master list (Document control log ) Document

1/4/09 31/3/10 John Smith,

Senior Technologist

5. Invalid or obsolete documents shall be promptly removed from all points of use, or otherwise assured against inadvertent use.

6. A retention period for out of date documents shall be identified (this is defined by the country’s regulations or laboratory policy)

7. Retained or archived out of date documents shall be appropriately identified to prevent their inadvertent use (for example by labelling as obsolete)

8. Only currently authorized versions of appropriate documents must be available for active use at relevant locations.

ELECTRONIC DOCUMENTS 

Electronic files comprise Quality System documents, data from tests, staff records, inventory files and client information among others. These must be protected from unauthorised changes and deletions. Password protection, administrator privileges and limited access to confidential information are techniques that can be employed to ensure the protection of important electronic files.

DOCUMENT IDENTIFICATION 

Unique identification numbers on documents should be easy to use, with a simple format followed throughout the QMS and communicated to everyone involved in their use. An example of a numbering system follows:

 All documents relevant to the quality management system shall have a unique identification, including:

a. Title (simple and relevant to the procedure)

b. Edition and/or current revision date or revision number (e.g. Edn 1 Revision 2) c. Number of pages (e.g. Page 1 of 6)

d. Authority for issue (not necessarily a signature, e.g. Authorised by…) e. Location of documents (including electronic documents)

EXAMPLE OF A DOCUMENT IDENTIFICATION SYSTEM 

The following is an example of a numbering system used by the GGMLab:

GGMLAB–X-000

P - Standard Operating Procedures (GGMLAB-P-001 series) R – Records (GGMLAB-R-001 series)

T – Test method Documents (GGMLAB-T-001 series) E – Equipment instructions (E-001 series)

L – Lists (L-001 series) F – Forms (F-001 series)

EXAMPLES OF HEADERS AND FOOTERS 

Figures 19-23 that follow present a variety of document identification examples including examples of headers and footers that meet the standard’s requirements for document identification. Any of these can be adapted for your quality manual and related documentation in your Quality Management System. Note that pagination can either be continuous or sectioned. Additionally, you should include a revision history for each individual policy and/or procedure as part of a standard header or footer. The revision history indicates the date when the document was last reviewed and what the current version is. This ensures that all persons have the same version and obsolete versions of documents are not used in the laboratory.

Figure 19 Example of Header/Footer comb ination

Figure 20 Example of a Header 

Section 1.0 Quality Manual Date Issued: 21/01/09 Page 1 of 1 Table of Contents  Authorized by: Lab Manager 

Revision 2 Approved by: Quality Manager  

Figure 21 Example of a Footer 

Prep Date: 05/11/10, Revision Date: 09/01/21 Quality manual Pg 1 of 42  Authority for Issue: Quality Manager 

Header :

Good Test Laboratories Quality

Manual

Section 0.0

TABLE OF CONTENTS

Page 1 of 1

Revision date: Jan 31 2009 Footer :

Prepared by  Approved by

Senior Technician Lab Manager 

Issue Number  Issue Date

2

Jan 31, 2005

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CONTROLLED AND UNCONTROLLED DOCUMENTS 

 All documents in the QMS should have some label or mark indicating whether they are controlled under the Document control system. Figures 22 and 23 below provide examples of acceptable control labelling. If the document is no longer under the control of the person responsible for Quality or the document has left the supervision of that person it is considered to be uncontrolled.

For example, a document sent to a person outside of the lab for review, for information, as a resource document, etc. This is applicable whether the QMS documents are in electronic or paper format. If your quality manual and procedures are primarily electronic documents where uncontrolled printed paper copies may exist, you can consider adding footers either electronically or you may use a coloured rubber stamp on the bottom of the printed pages to identify these documents

Figure 22 Example of Document control notes

Figure 23 Example Header/Footer with Document control note

Header : Good Test Laboratory

Quality Manual Section 5.1 Page1 of 2

Status: Approved Title: Document and Record Management Policy Version 2.0 Rev. Date: 2006/08/26 Footer:

Prepared by: Senior Technician  Ap proved b y: Lab Manager  Effective Date: 2005/08/26

NOTE: This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the document (titled as above) on the file server prior to use.

Notice: The hard copy of this Document may be used for reference purposes only.

The on-line copy must be considered the current document

NOTE: This is a CONTROLLED Document, as are all management system files on this server. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use.

2.6 RECORDS

The Standard requires that the Laboratory keep detailed records of all the activities it performs as proof that the activity has been completed, the data is correct or corrective actions have been performed to improve the process. Examples of laboratory records required by the QMS are data sheets, purchasing documents, training records, raw data from testing, sampling records and equipment maintenance records.

 All records must be kept in a safe location that allows them to remain legible and easily accessible and able to be disposed of in a manner that maintains confidentiality. A reasonable retention time, taking into account lab operations and storage options, should be established for each record. An example of an appropriate record management database is illustrated in Figure 24 below

Figure 24 Example of Record Management Database

Record Management Database

Name of Record

Type of Record

Date created

Retention time

Date deleted

Back up Created by

Entered by

Storage Location

Reference no

Comments

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CHAPTER 3 PROCEDURES