Picture the scene. The auditor opens her laptop and politely asks, “Can I see the training records for the person who performed this final inspection?” You smile. You nod. You do a little dance. This is Janet. Janet does know the line. Janet has known the line for fifteen years. Janet could run the line in her sleep, and on second-shift Tuesdays, arguably has.
You pivot to your filing cabinet and pull out a folder that contains, in this order: a 2018 OSHA bloodborne pathogens certificate, a printed copy of a LinkedIn Learning confirmation email, and a sticky note that says “Janet — knows the line.”
Dammit, Janet.
The standard does not care about Janet’s vibes. The standard cares whether you can prove Janet is competent — and that is what §6.2 is about.
What §6.2 Actually Says
Section 6.2 — Human Resources — is mercifully short. It fits on less than a page, which is the regulatory equivalent of “we trust you to handle this like adults.” The requirement boils down to one sentence: personnel performing work that affects product quality shall be competent on the basis of appropriate education, training, skills, and experience.
Then it gives you the five things you have to actually do:
- Determine the competence necessary for each role that affects product quality.
- Provide training (or take other actions) to achieve or maintain that competence.
- Evaluate the effectiveness of what you did. Did it actually work?
- Ensure awareness — personnel must understand how their work contributes to quality objectives. They have to know why their job matters, not just what they’re supposed to click on.
- Maintain records of education, training, skills, and experience. Records that exist. In a place. That can be found.
And there’s a little NOTE tucked at the end that nobody reads but everybody should: the methodology you use to check effectiveness should be proportionate to the risk associated with the work. A person sterilizing an implantable device requires a different verification rigor than the person ordering printer paper. Surprising, I know.
What This Looks Like in Real Life
Let’s translate this from standardese into “what an auditor is actually going to ask you about on a Tuesday morning.”
1. A defined competence requirement for every quality-affecting role
Job descriptions are a great place to start, but a job description that says “performs inspection duties as required” is not telling anyone what competence is required. Spell it out. What education? What specific training? What experience? What skills? Be honest about what the role actually needs, not what HR copy-pasted from a template in 2014.
2. Training that’s matched to the gap, not the calendar
Plenty of companies confuse “training” with “an annual compliance click-through.” Required training is fine. Effective training is what the standard wants. If someone’s role changes, the SOP gets revised, or a CAPA reveals that the team didn’t actually understand the procedure they were following — you train. And the trigger is the gap, not the date.
3. Evidence the training worked
This is the part most quality systems quietly skip. “Read the SOP and signed the log” is not effectiveness evaluation. Demonstrating that the person can perform the task correctly — through observed performance, a competency assessment, a successful first article, a quiz that isn’t open-book and isn’t multiple-choice “all of the above” — is effectiveness evaluation. For high-risk work, the evidence needs to be more rigorous. For low-risk work, less. The standard literally tells you this is okay.
4. Awareness, not just compliance
Subclause (d) is the one people forget exists. Your people need to know why. Why does the gowning procedure matter? Because contamination kills patients. Why does the final inspection matter? Because a missed defect ends up in someone’s chest. If your team thinks of the QMS as paperwork, you have an awareness problem, and an auditor with even a little experience will sniff it out in a five-minute conversation on the shop floor.
5. Records that can be retrieved, by an actual human, in under five minutes
Education. Training. Skills. Experience. For every person whose work affects product quality. Not “in the LMS but the LMS contractor changed three years ago.” Not “in Sharon’s old laptop.” In a system. With dates. Signed off. Current.
The Auditor’s Favorite Trick
An experienced auditor doesn’t usually start with “show me your training matrix.” They walk to the line, point at a person, and say: “What does this person do, and how do you know they’re qualified to do it?” If your answer requires more than a minute and doesn’t end with you handing over a record, you have a §6.2 problem.
The Bottom Line
Janet absolutely knows the line. That is not in dispute. But §6.2 isn’t asking what Janet knows — it’s asking how you know what Janet knows, and how anyone hiring her replacement will know what Janet’s replacement needs to know. Competence is not a feeling. It’s not loyalty. It’s not tenure. It’s a defined set of requirements, met through training that actually works, verified through evaluation, and proven through records. Anything less and you’re not running a quality system. You’re running on hope and Janet.