Monday, 5 May 2014


Part one of this series discussed the importance of increasing visibility into adverse events to assess their criticality and apply corrective action if necessary. In this instalment we will look into another essential element of the quality management system (QMS): document control... or lack thereof.

Document Control

Company documents include, among other things, information regarding processes and procedures for employee training, training statuses, job descriptions, work instructions, and more. It’s critical that this information be properly maintained and up to date across the entire enterprise.

Without standardized, accessible, and up-to-date documents, risk factors include:
  • Unsecured, outdated documents (particularly if they are used on the shop floor)
  • Training and status information that is inconsistent from site to site
  • Slow approval cycles
  • Non-compliance issues
  • Lag time in changes to documents existing in multiple locations
  • Difficulty of verification

For many organizations, documentation consists of a hybrid of software, paper, and tribal knowledge, e.g., Word, PowerPoint, Excel, database programs, files, folders, emails, Post-its, napkins, verbal exchanges, and even, “Ask Bob.”

There’s a well-worn manufacturing meme that depicts the confusion surrounding how the customer ordered it, how sales described it, how the engineers designed it, and how it was finally built. That same idea could be applied to document control. Who doesn't have an embarrassing or costly story about the results of poor document control?

For a document control process to be successful, it’s important to take a more structured approach.

An Automated Approach

One method of unifying and standardizing process workflow is to use document control software that is integrated with QMS software, also known as “automated” document control.

An automated approach—which is capable of fully integrating existing Microsoft documents—allows a business to set customized document workflow parameters and then let the software take care of the multitude of related tasks. Think of the time involved with each and every document used:
  • Creation or importation
  • Sequential numbering
  • Routing for approval
  • Revising workflow
  • Document distribution (e.g., individual, group, roles)
  • Document accessibility
  • Training for document users (requirements, notifications, status)
  • Periodic review
  • Archiving

And every bullet point has several sub-bullet points.

Taking a more hands-off approach to document control reduces the risk of human error, ensures that all employees are apprised of and educated about any new procedures, keeps all documents secure, and reduces the risk of non-compliance.

Implementing an automated method of managing your documented processes allows better control over the accuracy of all information.

Control over the document control process results in:
  • Increased efficiency
  • Enhanced productivity
  • Consistency in documents such as work instructions, job descriptions, training, and manuals
  • Assurance that all employees are using the latest released documentation to do their jobs
  • Security in knowing that the right people sign off on every document

An automated QMS provides a unified workflow process to guide all documents through a review and approval cycle. The result are documents that are standardized and are therefore consistent across the board.

By automating your method of managing documents, you will simplify the way you review documents, route these documents for approval, and make any changes to these documents later.

The process of training will be improved because you will be able to train all employees on applicable documents before their release. Ensuring that your employees are already up to date on these documents will promote a well-informed workforce with no lag time in the training process; they will already have been trained on a live document.

At some point, all organizations experience the need for change. None can remain static and continue to grow. Once faced with a document that needs to be revised it’s important that all documents be changed globally. Automating this makes the process much easier. Otherwise, each document that was affected by the initial change would have to be manually changed at each and every location—and just thinking about that is exhausting. If you can automate this task, you will be left with a common business method while having saved company and employee time in the process.

Furthermore, an automated document control system can tell you if there are dependent documents, those that are referenced by or must be changed if a higher-level document is changed. Just try keeping track of that situation with a spreadsheet.

A Real-World Scenario

Let’s take the case of a manufacturing company that manages more than 4,000 documents related to its processes. This company had no formal method of controlling these documents, which was reflected in errors due to outdated documents, improper training because employees were being trained on outdated records, and no link between document control and training processes. The result was inefficiencies in the overall process and an increase in the number of defect rates due to operator error, which was attributed to poor training. With these challenges, the company recognized the need for a change.

This company implemented an automated document control system that would enable it to keep thousands of documents within a single, centralized location and would enable more efficient training on documents. In doing so, the company gained a 25-percent increase in efficiency and reduced defects by more than 10 percent.

The company can now respond more quickly to change—in fact, new revisions are released 30-percent faster than with its previous manual processes. This in itself has cut the change process from an average of 30 days on average to just 10.

This company’s document control process used to require at least five people to manage it; with the automated process, it only takes one. By using fewer resources and cutting unnecessary paper waste, the company’s automated system has enabled it to incorporate lean principles into its operations and has freed up time for employees to do other crucial tasks.

Cost is another area where it has realized savings—to the tune of $200,000 in process enhancements as well as an annual cost of $150,000 that was previously required to maintain the manual process.

The Green Marketing Angle

Automation is also good for the environment. Automating your processes helps promote a lean business operation by minimizing paper waste and using fewer resources.

Many businesses are also discovering the marketing value of how company ethics (green initiatives like cutting waste via an electronic QMS) can be used in advertising materials.


Document control is a critical part of any organization, but the way you manage your document control process is just as important. Automation is the key to organizing endless amounts of documents faster and more accurately. And faster plus more accurate equals a better bottom line.

Source: Tim Lozier, EtQ Inc.

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