After supporting more than a hundred eQMS implementations in my role as head of Operations here at ZenQMS, I have observed that the conversion from a paper-based to electronic quality management system (eQMS) can be either painful and cumbersome or quick and easy. The determining factors seem to be centered on the ‘health’ of the business’ quality processes- especially those related to document management and training.
Below are 5 ‘low-hanging fruit’ type changes that your Quality team can make in order to prevent a significant and seemly insurmountable amount of work when moving to an eQMS now, or in the future. More specifically, I’m going to focus on changes to your document management and training processes that your Quality team can start making immediately. Some of these points may seem obvious, but these are items that our Implementation and Support teams consistently come across as obstacles when upgrading to an eQMS.
- OCR everything
This will save you enormous amounts of time when trying to track down a specific item, identify what went wrong, make a document change, respond during an audit, etc. If you haven’t heard the term OCR, it stands for Optical Character Recognition and it is the conversion of images of typed, handwritten, or printed text into a machine-encoded text. In the 21 CFR Part 11 sector, a common non-OCR document example is a PDF file that is a picture or scan of a physical SOP. The issue with non-OCR documents is that these files are not text searchable. Even if you can identify the correct non-OCR document, in order to find the specific item that you need, you will be forced to read through the entire document. Additionally, cloud-based applications with universal search functions (ZenQMS included) typically have the ability to search within OCR documents to find specific text.
- Limit potential contradictions (Document Names/Titles, File Names, Version Numbers, etc.)
This sounds like the most obvious item on the list, yet our Implementation team consistently needs to address this with new and prospective clients. When you create and maintain your quality documents, your team should focus on eliminating references that require manual updates.
For example, let’s focus on version control. If your quality system (cloud-based application or local software) automatically handles version numbers, do not include a version number that must be manually updated somewhere in the document. The most common instances are including the version number in the document title/name, file name, or in another application field. This issue compounds dramatically if you reference other document titles/names within a document. For example, a document titled/named SOP 102 v3 – Quality Lists is referenced in 5 different SOPs. When SOP 102 v3 – Quality Lists is up-versioned to version #4 using your quality system, the user performing this up-version will need to remember to update this SOP’s title/name to SOP 102 v4 – Quality Lists (1st potential contradiction). Once this document has become effective, the user will need to remember to up-version the 5 SOPs that reference SOP 102 v3 – Quality Lists because the document title/name is now SOP 102 v4 – Quality Lists (2nd, 3rd, 4th, 5th, and 6th potential contradiction). This same logic applies to paper-based or manual quality processes. Ideally, for these processes, you would only reference this version number in a dynamic header/footer or on a cover page.
- Reference vs re-using sections of other documents
This may seem to slightly contradict my 2nd point on contradictions; however, I believe that this is more of a corollary. If you’ve already done the work once, why do it again? In quality documents, there are many opportunities to reference information that might be detailed in another document. Fortunately, our clients and prospective clients typically catch these opportunities; unfortunately, these same teams typically don’t follow point #3. More specifically, if you copy a paragraph (e.g. blurb on training requirements) from one SOP (SOP 202 – Training) into another SOP (SOP 301 - Operations), you run the risk of creating a potential contradiction or an out of date section (this could be due to a change of the text in SOP 202 – Training). If you reference the SOP title/name instead (please see SOP 202 – Training, instead of copying the blurb), you only need to update this data in one place (SOP 202 – Training) and avoid the pitfalls (unless you’ve not followed point #2).
- Take an inventory of your employees, documents, and training records
Surprisingly, a majority of new and prospective clients have a difficult time providing accurate counts for these items. Most can give ballpark estimates, but do not keep track of or store these values. If you don’t know the full scope of your quality items, how can you tell if your quality system or process is doing a good job? This can be a sensitive topic in organizations and a task that doesn’t appear to have a lot of immediate value. However, this exercise can uncover previous hidden value (e.g. SOPs that could be consolidated) and identify potential quality gaps (e.g. missing batch of training records from a few years ago).
- Avoid training exceptions
This one is fairly straight-forwardj; don’t make exceptions when grouping people for training. If you find yourself explaining that the training is assigned to Manufacturing Management except for one employee or for all Document Controllers except for 2 employees starting after a certain year, you already have training exceptions and you have likely created additional work for your team. These exceptions can be difficult to explain and even more difficult to document. During times of transition, these exceptions can even turn into minor emergencies as new teammates struggle to explain, find documentation, or understand the reasons for these exceptions.