How do you manage "special responsibilities"?

One of the first things you learn when you write formal procedures is, Don't use personal names! 

Let's say you are writing a calibration procedure. As long as anyone can remember, Dave has been checking the calibration of all your tools on a rolling cycle, so he checks each tool twice a year and records the results in an Excel sheet. Finally you get around to documenting what he does in a procedure. What you must not write is, "Dave checks the tools twice a year on a rolling cycle." Why not? Because if you use Dave's name in the procedure, sure as anything he'll move to Tahiti next month and you'll have to update the document to name someone else.

So you replace Dave's name with a functional title, and write: "The Calibration Coordinator checks the tools twice a year on a rolling cycle." Note that this isn't Dave's job title. In many companies, Dave's job title is something like "Engineer 2" that can be correlated with his pay grade. And you certainly don't want just any old "Engineer 2" to do this job. The person who does it—Dave, or his successor—has to be qualified by knowing about calibration. That's why you create a special functional title just for the sake of this specific document, and you call Dave the "Calibration Coordinator."

As you write procedure documents for your operations, you'll do this several times—half a dozen, maybe more or less, depending on how complex or specialized your operations are. When you are done, you'll have a collection of functional titles that exist only in your procedure documentation, to account for specific roles your quality management system needs. These functional titles identify your QMS's Special Responsibilities. Of course in practice they just point to Dave and Pat and Sue and Sam, who handle the respective tasks. And when the auditor reads your Calibration Procedure and asks, "Calibration Coordinator? Who's that?" right away you say "Dave."

Then the auditor asks, "How do you know?"

Make a list 

One way to manage these assignments is to make a list. Seriously, it can be that easy. Just read through the formal procedures in your QMS, and write down every Special Responsibility they define. Then publish a List of Special Responsibilities (LoSR). For each entry in the List, identify the following four pieces of information:

• 
  Title of the role? (e.g., Calibration Coordinator)
• What document defines the responsibilities? (e.g., Calibration Procedure)
• Who is assigned to that role? (e.g., Dave Smith)
• Who is the Proxy, in case the regular assignee is out? (e.g., Pat Jones)

And that's it. The next steps are just as straightforward: 

• Make sure the List is formally approved by a suitable authority. (Since the list covers roles throughout your QMS, the "suitable authority" is usually your top management.)
• Formally identify the List as part of your QMS documentation.
• Maintain the List through formal change control, so that it is always up to date and so that the assignments are communicated to all stakeholders.

Enhance your documents

There's one loose end, but it is easy to tie up. Remember I said that not just anybody can be Calibration Coordinator? Spell out the qualifications for the role. 

An easy place to document them is in the same procedure document that defines the role in the first place. For example, your Calibration Procedure explains all the steps required to calibrate your equipment; so you can easily add one extra paragraph that spells out the necessary qualifications for the Calibration Coordinator. 

Then Dave's training records include an entry that shows how he met the qualification requirements. Maybe he took a class and got a certificate; or maybe he learned on the job from his predecessor, who sent an email when Dave was ready. Either way, the assignment and Dave's qualifications are fully traceable.

• The List of Special Responsibilites assigns Dave to his role, and references the document that explains it in detail.
• The document also lists the qualification requirements.
• And Dave's training records show that he meets those requirements.

If you have used other approaches you like better, leave me a note in the comments.