Document Mapping and Numbering

When it comes to organization of documentation system the most challenging task faced by any Quality system/document controller is document mapping and traceability. QS Documentation is divided into different tiers/ levels. However, such demarcation between different tires is never absolute and large numbers of cross over cases are encountered. Never the less these levels help in organization of documents. These tiers are depicted in the figure below:

Organization of documentation system aims to maintain flow of information and requirements from top down. In documentation mapping one has to verify the citation given in the documents and ensure the flow of information top down, flow ups is not a good practice.

Document mapping starts from Quality Manual and moves down.

Best practice is to highlight or use different font color to identify the cited references in the document.

Then prepare the list of such documents at the end of each document, preferably in the reference section.

Lastly review the cited references for correctness of the information.

Though it may seem cumbersome to perform such exercise, it is must for developing a correct, strong and reliable documentation system. One can use excel sheets to perform such matrixing and verification of the cited documents.

Once the exercise of the documentation matrixing is done a pattern in references comes out. Redundancy of the cited documents can be identified. These document follow 20%, 80% rule, i.e., most of the critical tasks (80%) in quality system are performed using these 20% documents. These highly redundant documents shall be reviewed minutely when change in documentation system is proposed.

Next important aspect in documentation matrixing is document numbering. 

Document numbers and document master lists forms document control database. The numbering system shall be self explanatory and understood throughout the organization. Different setups follow different document numbering systems which may include numeric or alphabetic codes. These codes shall be designed in such a way that they provide a clear traceability and ownership of the document.

To embed traceability in the coding system following information must be coded through document numbering system. These are

Company: Invariably a part of document header and thus can be omitted from the coding system.

Site Code: Identifies the site in case of multiple site scenarios.

Department/Function Code: owner of the document

Document Category: Code for documents at different tires such as manuals, procedures, protocols, work instructions, Specifications, Drawings, Records etc.

Document Subcategory: In complex documentation system document subcategories can be used such as Manual can further of different types, procedures can be administrative, quality system, testing, cleaning, validation, equipment operation, calibration etc.

Project/ Product Code: Incase of multiple projects or products

Document Number: specific number provided to a document in series

Revision number: identifying the revision of the document.

Examples of such numbering system is given below:

An example of numbering of QA SOP:

ANQA/SOP/QS001/00

AN: Site code

QA: Department Code (Quality Assurance)

SOP: Document Category (Standard Operating Procedure)

QS: Document subcategory (Quality System Procedures)

001: SOP number

00: Revision number

An example of productions SOP:

ANPR/SOP/EO001/00

PR: Production

EO: Equipment Operation (other categories can be CP: Cleaning Procedures, VL: Validation, CL: Calibration and so on).

ANPR/SOP/01001/00

01: Product Code (there can be multiple products having different product codes)

An example of specification:

ANQC/SPEC/RM001/01

QC: Quality Control

SPEC: Specification

RM: Raw Material (other categories can be PM: packaging material, INT: Intermediates, BS: Bulk Substance, FP: Finished Product, SOL: solutions, REG: Reagents, LBL: Labels etc)