Ever happened to you that your employee used the wrong document and caused a mass? Ever happened to you that a classified information reach the wrong hands and embarrassed you? Ever happened to you that you lost an important document and knew that your boss would get angry? For no reason? If do, please pay attention!
Using Document Control Software usually meets the ISO 9001 Standard Document Control Requirements. The document control requirements is one of the key elements of the ISO 9001 Standard requirements for achieving an effective quality management system. Without reliable control of procedures and records, a company’s QMS integrity will fail – as a practical business matter and as an auditable compliant system.
There are many solutions today for Documents control both manual and digital. In this article I will examine how one can achieve the requirements with digital solutions. Pay attention, we didn’t write software but a digital solution. Digital solution must not be a document control software
There are two kinds of documentations in organizations. The first is the ISO 9001 documentation requirements. For The second, (other than is required) the organization must identify and document “needed” processes (activities with inputs and outputs). Of course documentation should be appropriate for the size and type of the organization, the complexity and interaction of processes, and the competence of personnel. In other words, don’t go over your heads, you would regret it in the future. The purpose is not to turn the organization to be a secretary for the ISO 9001 Standard.
The first level of digital documents control
The first level of digital documents control over organizations is laid with its management systems. Management systems are software designed to support some of the working processes. The system can be an ERP system, a CRM system or any other system. As long that it documents the working processes. Within the system forms are implemented (screens). The system guides you to fill the correct information at the correct location. Eventually, the information is at the right place and time, organized and being controlled. Even distribution of the information is managed. This is what documents control is all about. So, when you are documenting your QMS and prepare yourself for the terrifying audit, any process that is included within the QMS and is documented via the management system – is covered. But you will have to mention it in the procedure. Don’t say I didn’t tell you.
Basic electronic systems
The most common digital way today is still using the local computer network and email systems for documents control. The Documents management is usually being realized when folders or directories are established and usually it is done locally (a department or a division). The documents are saved on the server for use. Sometimes the system administrator or maybe the quality manager requires that the document would be protected by any changes – the “read only” possibility. The types of documents are varying from forms, procedures, records, plans, work instruction, diagrams etc.
As for routing documents, the email as become the main communication channel. People send as attachments documents for review or for use.
Now, you may think that this is a digital documents control but in fact you only get digital documentation but no control what so ever! Why? First, when you save a document on the server it is actually a manual management and not a digital management. It is correct, the document is digital but the management is manually. The employee saves it in the folder and names the document. He has full control over it. God knows what he is capable of doing with it. Digital document management requires that the document would be submitted via the documents control management system. This way, the system is registering the document and then begins managing his lifecycle. Now, no employee of yours registers any document that he saves on the local net. Correct me if I am wrong.
Second, when you send an email with an attachment it is like exporting a document out of his system and into an individual independent lifecycle. The person who receives this attachment would probably save the massage with the document and whenever he would need it, he would brows through his mails the get the document. Everybody does it. He could make changes and you wouldn’t know anything about it. Tracking those documents, comments made by reviewers, and the final approval history are not automatically accessible in a manual email routing system (which are the common ones). Even if documents are sent through email, system administrators must manually track, update, and communicate the review they receive. To make it more clearly, it is an open loop system. Not to mention the ineffective storage results.
With digital document management system you won’t send the document but a link or any other trigger to access the document via the documents control management system.
Third, even when you save a document and you characterize it as “read only” – that prevents no one from saving the document on his computer, edit it and spread it throughout the organization. Again you are back to an open loop system. Sorry. O.K. Even with the strongest most sophisticated digital documents control management systems you can never, really, prevent that. No matter what anyone tells you. You are depending on your employee and his willing to follow ground rules to ensure regulatory compliance. At the end of the day, we are stuck with the human factor.
So with manual (as if – digital) document control we achieve three things: an open loop method for document management, a document exporting out of the loop and an independent lifecycle for documents. The three things the ISO 9001 Standard is trying to avoid.