What do I mean? You know, job aids, tools users have created, and SME cheat sheets. I’ve even seen task instruction sheets, quick reference guides for completing forms, and process flow diagrams. But I’m not talking about posters on the wall describing how to turn on the projector in the conference room. In this 3rd issue of Making It Work for Compliance Trainers series, I blog about why creating and openly sharing user-generated tools may not be a good thing in a regulated environment.
As a Performance Consultant (PC) or HPT specialist, works with SMEs, Key Performers, or STAR employees, s/he invariably uncovers or discovers that their SMEs have “other” tools they’ve developed that help them be so good at what they do. While these are helpful to the key performers, it presents a dilemma for the PC who is also a Compliance Trainer or a QA Manager. “If I expose the source of their secret sauce, will I break trust and create a barrier to the relationship? On the other hand, if I don’t speak up about this tool, what assurance do I have that the content is approved by the Quality Control Unit (per GMP) and is version controlled?
Why create them in the first place?
To get grounded, the PC/Compliance Trainer needs to perform a quick cause analysis upon the discovery of the tool. Why was it created in the first place? Is there information or steps missing from the standard operating procedure (SOP)? Was this tool created to “chunk up” the steps or create bite-sized training materials that evolved into a job aid? Or is it a maneuver to bypass the change control system? The answers to the questions could provide the basis for a more user-friendly revision or at least be officially approved as a supporting tool to the SOP upon the next version release.
What’s the big deal?
Rejection of product, deviation from approved written instruction that could result in adulterated product, additional follow up testing, and rework are all forms of waste to the organization. Not to mention that consistency is the key to compliance and assuring public confidence in approved marketed products. If folks are not using the approved procedure, then there’s an issue somewhere.
To what level of control is needed?
That is the most sought after question regarding job aids and user tools. The answer lies in each company’s level of risk and its document hierarchy. I’ve seen extreme cases where “NO Paper” on the floor means not even an SOP is allowed to be in hand. I do believe that some level of control is needed to ensure that the content is valid, is in sync with the current procedure and users have the most current version of the tool. Can your organization defend the level of control? Are you sure about that? Or do you use a “don’t tell and we won’t ask policy”? Are folks making errors because they followed an uncontrolled worksheet vs. the approved procedure?
Tips for Establishing Level of Control
- If the tool /job aid is tied to a procedure, it needs to become a required tool and included in the SOP.
- Job aids should not be a standalone orphan. It needs to have a procedure that it supports. The use of the job aid is included in the hands-on training so folks know how to use it properly and where to access it if it is not “attached” to the SOP.
o For example, some companies have a separate numbering system for these exhibits and the storage location may not be in the same folder directory as the parent SOP.
- If more than one tool / job aid / worksheet exists per procedure, then an appendix or reference section needs to highlight the existence of these “tools in use”.
- Establish an amnesty initiative to raise awareness for the quality and compliance consequences of using uncontrolled tools.
Calling all User Generated Tools Home
The purpose of the initiative is to allow users to admit that they have these tools and that no performance consequences will follow when they surrender them. The second focus of the program is to find a proper home for these tools once they are deemed valuable. They need proper care and nourishment. In other words, content is valid, accurate, up to date and approved for use. The PC/Compliance Trainer is the ideal conduit to make this happen.
One company that I visited did just that and more. Once it was discovered that a series of mistakes were coming from an old tool that had been downloaded and copied to their desktop, a team of auditors was dispatched to observe the removal of all tools from employee’s desktops. The 2nd phase of their program was the identification of an owner for the share-point site who now manages access and content revisions. The 3rd phase includes a content/tool submission process that is vetted by a designated users group of SMEs.
Is it time for a Job Aid/Users Tool Amnesty Project where you work? – VB