Background

Document control represents the Number One source of nonconformities in audit certification. 80% of nonconformities detected in audits are related to document control. Despite the efforts of the person responsible for document controlling, it’s very common for some people to present outdated copies of documents or for a person not to have access to an important document.

It is not good that most of the nonconformities detected in the audits are aspects that do not directly affect product quality. The organization strives to provide quality products and services, and the auditors indicate by a notation in the documentation control that it may be irrelevant.

Description of the solution

QDOC is a communication, management, and retrieval of a document system that will help to improve document control. It meets the requirements stipulated in the standards on data and document control.

When someone with permission modifies a document, QDOC notifies the reviewers who must then approve the changes, following a defined workflow where each step has a specific time in which to materialize. Upon approval of the changes, the document is automatically visible to all users who have permission to read.

If any of these activities are not carried out in the required time, they are included in a delay report that QDOC automatically generates and sends once a day to a configurable email address. This address can be the quality manager, director, or any concerned authority of the organization who wants to know about the document control operation. This way, management is aware of how its quality system is working.

Computers take over the control. No more forms filled out. We have effectively stopped working for the management system and now the management system starts to work for us. The people responsible for quality can concentrate on their work because the administrative part is done by computers.

And do they read the documents?

A critical problem in organizations is that many people are provided with copies of procedures, instructions, etc., but they do not read them. (Just keep them safe in a folder that looks great as desk ornament.) With QDOC this is solved because we always know who reads each document. We can make sure that users are aware of new changes, because when a change to a document is approved, QDOC informs everyone that there was a change and requests confirmation that they understood the changes. Therefore, these are also spread electronically.

With an easy-to-operate interface, QDOC guarantees that:

• There is control over the outdated documents.
• Modified documents are reviewed and approved prior to their issue.
• Changes and current revision status of documents are identified.
• Documents remain legible and easily identifiable.

Features and Benefits

• Fully covers the requirements of the ISO 9001 standards.
• Allows developing a policy and procedure for document control.
• Maintains a master list of documents including document identification, date of issue, and release of each controlled document.
• Ensures that only authorized changes can be made to the documents verified.
• Ensures that an approved procedure is in place, and monitors all the changes and revisions by the appropriate individuals.
• Ensures that controlled documents are available to whoever needs them when required.
• Ensures that only the current and approved version of each controlled document is used.
• Keeps records that show the revision history of the document.
• Alerts, at the right time, information about the documents waiting for revision and/or approval.
• Works in a network. Multiple users can use the system at the same time.
• There is no need to rewrite documents. QDOC incorporates documents into its database from any application installed on your computer.
• Protects the content of the documents. A user without permission cannot extract information.
• Customizes fields and reports.
• Provides WPF technology that allows installs on the server and then runs the program from any PC as if it were local.
• Is easy to use.
• Is friendly. Maintains design standards of MS Office.
• Tracks all changes that occur in the system.
• Allocates time for compliance steps.
• Sends email delay alerts to the responsible person, with a copy to the head of the department.