The environment for the operation of processes (in the ISO 9001:2008 Standard identified as work environment) consists of the premises, sites, and locations where process-related activities (by employees or not) are being carried. I will refer to it from now on as “process environment.” The process environment is supposed to provide the manufacturer or service provider with the optimal conditions for the realization processes and thus has a direct effect on products or services. The process environment includes not only the physical locations, but also the influence of equipment or materials used during the realization processes. The goal of controlling the process environment is to determine, define, direct, monitor, regulate, coordinate, and, when necessary, document the conditions of the process environment. It will be done by introducing the environment to predefined activities and controls. The activities cover specific areas, and their parameters are confined to specified limits or definitions.
The ISO 9001 Standard requirements refer to all areas, spaces, and halls that serve the organization for operation and realization of products or services. These conditions are included under the following categories: physical elements of work spaces, factors that may influence the processes and activities, and resources that are three parameters:
- The ability of activities and operations to achieve expected results and product requirements according to customer satisfaction and regulatory requirements
- The ability of the process environment to support the resources that operate business activities
- The ability of the process environment to support the safety of products—the conditions of protection against consequences of failure, damage, error, accidents, harm, or any other event that could be considered as nonconformity
Processes Environment versus Infrastructure
Before we start to specifically decipher the requirements, I would like to start with distinguishing between infrastructure and process environment. When infrastructures include machines, the process environment is the area around the machine that is needed to realize products: a place for the worker to operate the machine, lighting above his head, the noise around the workstations that may affect the worker, and the area where the process outputs are being kept. Maintaining and controlling an infrastructure would require a periodic control plan—in our example a maintenance plan for the machine. Maintaining the process environment would require a control that certain conditions are being achieved—periodic inspection around the machine: cleanliness of the work space, sufficient lightning, appropriate storage conditions, and safe work environment.
Definition and Determination of Process Environment
Defining the necessary conditions and applying the controls for process environment must cover all different areas and scopes of the realization processes. For example, storage of raw materials, parts, and components; aisles for transportation between departments and areas; manufacturing; and production halls for manufacturing and assembly activities. In order to reach and identify all the elements of process environment that may affect the goods, services, personnel, or processes, it is necessary to conduct a review, analysis, and assessment of all realization activities and processes and their outputs.
Review and Evaluation of Risks Related to the Process Environment
Process environment may cause a failure in the product when the required conditions are not provided and maintained. Actions necessary for addressing risks are referred in the ISO 9001 Standard in clause 6.1—Actions to address risks and opportunities. Let us discuss the principles in order to understand the effect of risk on the process environment. The principle of risk management is evaluating situations that may set hazards to the realization of products and services at certain points, evaluating their degree, setting controls and measures for eliminating or reducing the hazards, and evaluating the effectiveness of these controls. Outputs of the risk review and evaluation shall be integrated in the planning actions for control of the process environment. I suggest here a sequence for identifying the related risks of the process environment:
This webpage contains only a fragment of the chapter 7.1 Resources from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001: 2015?
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