Document Control as Part of Quality and Compliance Requirements
Broadly defined, document control refers to strategies for managing the development, approval, issue, change, distribution, maintenance, use, storage, security, and disposal of documents. In other words, document control provides a framework for managing document life cycle – how documents are approved, updated or amended, how changes are tracked, how documents are published (internally or externally), and how documents are made obsolete. When such framework is properly documented, it becomes a document control procedure or policy. Such procedure should be tailored to the needs of the organization that must use it. It should be practical, less cumbersome, and clearly written. No document control mechanism can be useful if it is not explicitly documented and made part of the everyday routine.
Many organizations in Nigeria do not have clearly stated document control procedure in form of policy. This often leads to undisciplined approach to the handling of documents. Documents are created in casual manner, stored casually in any hard drives, passed around in printed form, forwarded to others as e-mails, and finally deleted when desired. This results in preventable challenges with compliance programmes and requirements which may manifest in forms of unapproved or out-of-date procedures, uncontrolled documents, lost of or difficulties in accessing important files, inconsistent conventions, etc.
Controlling documents is a key requirement of the International Organization for Standardization (ISO 900), and Document Control Procedure is one of the required documented procedures.
The following documents must be controlled:
- Internal documents (like Quality Policy, Quality Objective, Quality Manual, Quality Procedure, Work Instruction, BOM, Inspection Standard and etc)
- External documents (like Law Book related to organization, Customer Drawing, Customer Specification Requirement and etc).
- Records, in ISO 9001 system, Quality Records and Forms (like Inspection record, Production Record and etc) are a special type of document.
ISO 9001:2008 – Control of Documents 4.2.3, identify seven key controls:
- To ensure any controlled document must obtained approval before release and distribute to other.
- To ensure any new revision of documents have been reviewed and approved before release and distribute to other.
- To ensure the revision of document is proper identify.
- To ensure relevant version of documents are available to retrieve at point of use. (In other words, we must establish a system to ensure our documents are able to retrieve when necessary)
- To ensure documents remain legible.
- To ensure all external documents determined by organization are following the same process as mentioned above.
- To ensure any old version of documents are obsolete to prevent the unintended use. If organization need to keep any obsolete document, suitable identification to these documents must control.
In addition, ISO 9001 differentiates records from documents. According to the ISO 9001, a document is an “information and its supporting medium”, while a record is a “document (a special type) stating results achieved or providing evidence of activities performed”. Examples of documents include instruction manual, management procedures, policy statement, etc; while records includes training or educational certificates, order receipt, payment vouchers, etc. Therefore, a document has information value while a record has an evidential value; all records are always documents, all documents do not qualify as records.
The ISO 9001 stated 5 controls in Records Control Procedure (4.2.4), namely:
- To ensure identification of record, in common practice, we will assign a form number to identify it.
- To ensure the storage methods able to prevent damage, lost and able to retrieved by other
- To ensure the retention of records are identify clearly.
- To ensure the disposition of records are identify clearly.
- To ensure records are remain legible to other.
By Ekhorelen Fidelis