Companies train their personnel in all sorts of FDA-related activities, from quality system SOPs to core regulatory requirements to company policies. Training is a common requirement of nearly all FDA regulations, from Part 11 to 21 CFR 820.
- What about training should be documented?
- What should be retained and for how long?
- Should training records be tied to individual personnel files or can we simply record group training?
- How do I go about figuring out who should be trained on what?
These questions carry with them significant risks - for FDA compliance, for product liability litigation, and for personnel-related allegations. When I give FDA compliance training workshops, webinars and speeches, many questions about training and training records often boil down to these tricky issues. Below, I'll answer a few aspects:
What specifically does FDA require us to document about training?
In only one place does FDA spell out specific items to document, in 21 CFR 111.14(b)(2) Current Good Manufacturing Practices for Dietary Supplements. FDA states: “You must make and keep the following records: Documentation of training, including the date of the training, the type of training, and the person(s) trained.”
At minimum, I suggest that ALL firms, irrespective of industry, follow the minimum specifics listed in 21 CFR 111.14. All the other regulations provide a summary statement similar to the one in 21 CFR 820.25(b): “Training shall be documented.”
Unfortunately, in part because of these ambiguous requirements, a bad habit of using group attendance sheets has arisen over the years. Such group attendance sheets are easy, they get passed around, people sign their name, and voila – regulatory requirements met…right?
No.
Group sign-in sheets have multiple inherent weaknesses that - as many firms have discovered - undermine compliance. For instance:
- When did the individual sign? Did they walk into training 5 minutes before the session ended and sign the sheet? Did they walk out of training as soon as they signed the sheet to “take a quick call” and never return?
- Was it actually that individual? How often does someone match the signatures against a signature log?
- How does signing a group “I showed up” sheet prove “I understand the training and I agree to abide by the training” with any level of accountability?
The reality is that most group attendance sheets go into a file drawer and are never seen again. FDA investigators understand that group attendance sheets prove little. In fact, in 32% of product recalls, FDA traced the root cause to ineffective training (US Federal Register, Vol 78, Iss. 11, 16 January 2013).
The proposed 21 CFR 117 specifically ties training to individual personnel records, eliminating the ability to use group sign-in sheets to prove FDA compliance. Supervisors are to be trained differently than line workers. And supervisors will have a responsibility to “ensure” that employees understand their obligations. Group sign-in sheets will not accomplish this.
Group sign-in sheets carry further risks for a company in two increasingly common situations:
- Product liability litigation
- Personnel discrimination or wrongful termination allegations.
Multiple US laws and regulations tie retention of training records to individual personnel files and roles performed. A 2008 SCOTUS ruling (CBOCS West, Inc. v. Humphries) on the statute of limitations in Section 1981 of Title VII (42 USC 1981) determined that job-related training records – such as training on SOPs – are examples of proof that can be used to show a company discriminated (or conversely, used to prove that a company did not discriminate) for several years after an employee's departure. As a result, firms now keep job-related training records for the duration of an employee’s term with the company plus at least two years (e.g., "date of departure + 2 years").
So how does your Quality group track the employment durations of each individual with your company? Or perhaps they are planning to keep every single group sign-in sheet for at least 30+ years?
These are just some of the reasons why group sign-in sheets for training now cause more risks and problems than they solve.
What record(s) should I retain to prove personnel were trained appropriately and understood the training?
With my clients that I help either in FDA quality system consulting or in FDA recordkeeping consulting, I recommend retaining two record types:
- Training Matrix
- Individual Certificate of Acknowledgement
About the Training Matrix
A Training Matrix can be as simple or as complex as you desire, from a basic Excel spreadsheet to an Oracle or SQL database of some sort. Using an Excel spreadsheet, the left-hand column should list all the organization’s personnel; the top row should list all the potential training that could be received (specific SOPs or policies, regulations, etc.). The grid is then filled in either with the date last trained or with a shaded cell to indicate “not necessary.” Feel free to come up with other designations for date scheduled, type of training (“in person” vs. computer-based vs. “read-and-review”), and so on.
The purpose of the Training Matrix is two-fold:
- Tracking who needs to be trained on what versus who has already completed training; AND
- Quickly and easily showing an outside auditor or regulatory investigator the current “state of training.”
From a retention standpoint, the Training Matrix is what’s termed a “living” document. It’s constantly updated.
That said, from a risk-mitigation standpoint, I suggest my clients take an annual snapshot of the Training Matrix and archive that annual snapshot for a period of years equal to their local state statute of limitations such as 3 years or 6 years. Such a snapshot of a "living document" is not required under any regulation, it’s simply a precaution to allow the firm to quickly and easily trace who had training on what and when without having to cull through individual personnel records. It's a reminder that the Training Matrix is designed to be practical and user-friendly throughout.
With any luck, the Training Matrix is as far as the FDA investigator will need to go. However, deeper dives into specifics of what a person was trained on within a particular training session as well as the how the supervisor ensured the training was effective look to Individual Certificates of Acknowledgement.
About Individual Certificates of Acknowledgement
In each individual personnel record is the Individual Certificate of Acknowledgement.
An example Certificate of Acknowledgement documents the following items:
- Topic of training session
- Date of training session
- Key responsibilities/requirements covered in the session
- Individual’s acknowledgement that he/she understands his/her obligations
- Individual’s agreement to comply with the requirements/obligations
- Supervisor’s review and agreement to supervise the individual to the requirements/obligations.
Not only does this comply with both the intent of the regulatory requirements, it also has a critical added benefit: since the 1950s, studies have shown that this type of written, individual acknowledgement consistently improves compliance by up to 89%.
This is why the individual Certificate of Acknowledgement (or “Commitment” or “Understanding” or whatever word you want) is so powerful:
- Improves compliance by 89%
- Complies with all current US laws, court interpretations and regulations associated with training records.
One tool to comply with multiple regulations and strengthen compliance at the same time: that’s a lean compliance technique.
How do I begin to create role-based training assignments when there might be hundreds or thousands of SOPs and policies?
The key challenge is to avoid getting lost in the details. Training everyone on everything is nice in theory, but breaks down quickly in practice; the larger an organization, the more unwieldy and ineffective the training will become.
Traditionally, there are two choices in how to tackle role-based training:
- Work with your local HR/personnel department to idenfity overall training requirements for each functional group; OR
- Work with each functional leader (department heads, team leads, etc.) to do the same.
I advocate a more practical, flexible lean compliance approach:
Assemble a temporary, working group of representatives from each functional area and HR to carve out initial sets of "buckets." In essence, everyone in functional group X gets trained on SOPs 1 and 2; everyone in functional group Z gets trained on SOPs 2, 3, and 4; everyone in functional group A, gets trained on SOPs 4, 5, and 6; and so on.
That's the core initial population of the Training Matrix.
Then, I take that initial populated draft of the Training Matrix and go to each department head to review, tweak, answer questions, and verify. After the quick verification sessions with the department heads, the Training Matrix is now fully populated, the functional heads and their direct reports are happy, and so is HR. It's a win-win-win.
And I don't worry about "is the Training Matrix perfect?" because it is - as I noted above - a "living document" that will get modified as time goes on.
This can also help reduce the drag of training on productivity. The more time spent in training, the less revenue-generating work is completed. Thus, the goal of the business is to have the minimum amount of training necessary; in other words, to balance compliance with profitability.
FDA lean compliance provides a company defensibility with records while reducing overhead, strengthening compliance, and improving profitability.
To learn more, visit my firm's website at www.ceruleanllc.com or read previous client stories and testimonials.
