Document Control System Implementation

Document control is revision control of documents, assigning and tracking documents numbers, change control management, assuring documents compliance, documents routing and tracking. It can also include Bill of Materials (BOM) and Approved Vendor List (AVL) management. Document control could either exist separately or could be a part of content management activities.

In companies, especially in regulated industries, there are document control people for performing document control functions separately. They do not have any functions related to content management. Document control is usually part of QA. It is mandated function in regulated industries. Document control is a part of ISO 9001 and GMP/GxP requirements.

The primary purpose of document control is to ensure that only current documents and not documents that have been superseded are used to perform work and that obsolete versions are removed. Document control also ensures that current documents are approved by the competent and responsible for the specific job persons and are distributed to the places where they are used.

How to implement the document control system and where to start? This is the subject of my today's post.

In order for your document control project to be successful, I recommend that you follow these steps in this specific order.

Select a System

Select an electronic system in which you are going to control your documents. If you already have a content management system in place, it could serve document control purpose as well. If you don't have a content management system, select a system specifically designed for document control. Most widely used and popular systems specifically designed for document control are Agile, Arena, and Omnify. If in future you decide to implement a content management system, you would be able to integrate it with your document control system.

Define Controlled Documents

Controlled document is any document that is used to perform work. Reference document is any document that is used for reference only and NOT to perform work. These documents must NOT be used to perform work.

Identify all your document types, for example specifications, drawings, schedules, meeting minutes, etc. Among these documents, identify which documents are going to be controlled documents and which are going to be reference documents.

Be careful about designating documents as controlled. Controlled documents must be approved by authorized approvers in order for them to be valid and to be able to use them. The author or modifier of a controlled document must get this document approved before it can be used to perform work. Each controlled document would need to have a number. All controlled documents must be accounted for, their distribution is strictly controlled. For this reason, choose your controlled document types with great care.

So, if a document so not need to be approved or their distribution is strictly controlled, make it a reference document. For example, if a document is going to be used for work and this work needs to be controlled as far as its quality and safety, then this document should be controlled.

Define Document Approvers

Define who in your staff is going to approve documents when they are going to be created or changed. Define the procedure for documents approval.

ECO Process

When a new document is created or a document is going through a change, Engineering Change Order (ECO) is used to document and approve the document creation or changes. It can also be called Engineering Change Notice (ECN) or Document Change Notice (DCN). ECO outlines the proposed change, lists the product or part(s) that would be affected and requests review and approval from the individuals who would be impacted or charged with implementing the change. ECOs are used to make modifications to components, assemblies, associated documentation and other types of documents.

The change process starts when someone identifies an issue that may need to be addressed with a change to the product. It ends when the agreed-upon change is implemented. ECOs are used in between to summarize the modifications, finalize the details, and obtain all necessary approvals. Every time a document is created or changed, ECO would need to be created and used to get this document approved.

You would need to assign a number to each ECO and if you are not using an electronic system for generating ECO or lists which could be used as ECO list, you would have to scan and upload ECO into your system.

Taxonomy

Every information system should include two access points to information: search function and browse function. Users use search function when they know exactly what they are looking for. Users use browse function when they do not know what they are looking for. Taxonomy needs to be created to accommodate the browse function in the system.

Users do not always know what they are looking for. In fact, in most cases, users do not know what they are looking for or they know it but are not able to find it using search. Users are going to look for ways to find documents. It is easy to find uncategorized documents when there are just few of them in the system. When there are many items in the system, it is going to be very difficult to find them.

Create taxonomy for your documents. Taxonomy should be validated in the user study and user side testing when necessary and adjusted as needed.

Metadata, Naming Conventions, Controlled Vocabulary

Metadata

Metadata values for documents need to be defined to accommodate the search function of documents in the system. Each document type should have metadata assigned to it. Metadata values would be the criteria that users need to use to search for documents.

The general system search will accommodate the full text search of content. This search would be sufficient when there are just few documents in the system. When there are many documents in the system, the general system search will retrieve a long list of irrelevant items. Users are not going to browse through long lists of items. To make the search precise, the presence of metadata is necessary. If metadata is present, the search can be performed using metadata rather than full text search.

Metadata should be validated in the user study and user side testing when necessary and adjusted as needed.

Naming Conventions

The role of naming conventions is very important in order for users to identify documents in the list without opening each one of them. Naming conventions should be created for each document type. Naming conventions should be validated in the user study and user side testing when necessary and adjusted as needed.

Controlled Vocabulary

Controlled vocabulary is the list of controlled terms that should be used for some of the metadata fields. These controlled terms should be standard terms used in standard publications, documents, majority of users, etc. Controlled vocabulary would help to ensure that metadata values are consistent. Consistent metadata will ensure high precision search.

Assure Documents Distribution

During this step, you need to make sure that everyone who needs the document gets a copy.

Distribution may be physical (paper documents) or electronic. When posting the document on intranet or other electronic systems, ensure that everybody who needs to have the new document knows about the posting (e.g. through an email or workflow notifications). When distribution is physical (paper documents), documents need to be stamped to identify that this is a controlled document and that a user of this document needs to verify that this is the most current version before starting work.

Controlled documents need to be watermarked so that if they are printed, users know that they need to verify their version before using them.

An inventory of controlled documents should be created with the exact location of each controlled document.

Remove Obsolete Documents

This is easy if you use an electronic documentation management system but is more complicated with hard copy documents. Each hard copy document must be replaced when it has been changed.

You may request the receiver of new documents to send back obsolete ones. If for some reason you need to retain obsolete versions of documents, they need to be marked to avoid unintended use. Many organizations use a stamp: "obsolete document".