Another 2016 clause without a requirement for documented information. Neither maintained or retained (we remember the difference?). You know; maintained are procedures, videos, flowcharts, etc with retained being, well let’s just say it… records.
The standard is quite explicit; The company ensures that persons doing work under the company’s control are aware of: the Quality Policy; relevant Quality Objectives; their contribution to the effectiveness of the Quality Management System, including the benefits of improved performance; and lastly, the implications of not confirming with the Quality Management System requirements.
While the standard does not require a procedure, we always write a procedure around this clause. It takes the ambiguity out of the rules. Especially the format, protocols, structure, the quorum (or at least the defined minimum) so that you are in control of your determinations of effectiveness.
And then there is the gotcha. “all persons’ doing work under the company’s control.” Yes, all persons. All persons representing themselves or external providers. Maybe even interested parties! Well of course they should be included as they are contributing to the success of the quality management system and the company. Whether they are contributing internally through subcontracted expertise or representing you to external parties, equip them with the information they need to do the job right and so they know the impact they have on your systems.
I think it is pretty hard to do any of this without generating documented information. So, don’t be afraid to do so. As always, road map such information through your cross-reference table and voila (fancy, huh), you will have evidence of effectiveness of this clause well managed.