I'm looking for ideas and best practices for tracking training records and managing tracking of training of SOPs. Most training is instructor led or self-directed(read the SOP) and we require proof of training for auditing purposes.

Like to understand your needs a bit more- consulting to financial services who were big into "self-reporting", but external auditors demanded more rigid controls. Before I opine, I would like to understand the audit purpose and impact on the business.

My company provides helpdesk services to the pharmaceutical/clinical industry. Audits are conducted by our clients as per regulatory requirements; training records are a part of the audits. Appreciate any thoughts.

Hi:Some ideas. Do you need to produce hard evidence of the completed training, like tests, quizzes, checklists per employee? Is training a centralized department or it is spreaded into different groups? If the training function is centralized, I will go and prepare a document with each position, and the required training, then for each position I will put the name of the employee and the date when the training was completed. Then prepare a file with all the training notifications, tests, signed documents, etc. for each employee. So if an auditor come and ask, you can show the evidence.
If the training functions are decentralized, write an SOP to ensure that every group will follow the same procedures, so no matter to whom the auditor ask everyone will answer the same way.
Hope this helps!

Ines Serra
Comunica Solutions

I think IMS really makes a valid point with hard evidence.

We are heavily audited, not only internally, but by external auditors- the idea of managers or even instructors "certifying" folks was a slippery slope. Esp. with managers- if they are rated on employee development, or employees can't sell X product until certification, it is a conflict of interest to have the employees certified even when the skills may not be up to par.

This is what got us into an audit situation- some managers were certifying folks even though they probably didn't truly measure to a level of certification.

We switched to hard completion metrics that can't be faked or entered by anyone other than on objectived (certified) system administrator. Kept auditors happy and everyone honest.

IMS did mention key steps on structuring it, but the point about hard (and I'd add objective) evidence, really gets to the core of bullet-proofing audits (since implementing, despite system issues, we have had zero audit issues).