Audit Scenario – Work Environment
By Lynn Clyde – BRC Quality Consultant
The following is a typical auditing scenario that might be found when auditing an ISO 9001:2008 quality management system for clause 6.4 Work Environment. Read the scenario to determine if you think it would be conforming or nonconforming, then read the answer and explanation.
Support Information – ISO 9001:2008 Clause 6.4
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
Note: The term “work environment” relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).
The internal laboratory that did critical testing for the organization had documents which indicated the lab should be kept at a constant temperature of 20 degrees C, plus or minus a degree. The thermostat was set at 20 degrees, and it was checked every hour by the lab employees, but there were no records as evidence of this being done. When asked, all of the lab employees knew that it was supposed to be checked on an hourly basis.
Conforming to Clause 6.4.
The work environment consists of the human and physical conditions that exist in the workplace that affect conformance to product requirements. This includes lighting, heat, noise, climate, cleanliness, pollution, ergonomics, health & safety, WHMIS, etc. It is up to each organization to determine and identify what it requires and it is often done as part of management review, strategic planning, quality planning, project planning, etc. There is no requirement in this clause for keeping records (although it is recommended), as long as the appropriate employees know what is to be done and when, and state that it is being done.