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This document outlines the key areas to evaluate when conducting a process audit, including equipment and facilities, personnel, control processes, process inputs and outputs, instructions and procedures, support processes, and key performance indicators. The auditor is directed to review documentation, observe the actual process, and interview personnel to evaluate whether the process is properly defined, controlled, capable of producing conforming product, and meeting its quality objectives and customer requirements.
This document outlines the key areas to evaluate when conducting a process audit, including equipment and facilities, personnel, control processes, process inputs and outputs, instructions and procedures, support processes, and key performance indicators. The auditor is directed to review documentation, observe the actual process, and interview personnel to evaluate whether the process is properly defined, controlled, capable of producing conforming product, and meeting its quality objectives and customer requirements.
This document outlines the key areas to evaluate when conducting a process audit, including equipment and facilities, personnel, control processes, process inputs and outputs, instructions and procedures, support processes, and key performance indicators. The auditor is directed to review documentation, observe the actual process, and interview personnel to evaluate whether the process is properly defined, controlled, capable of producing conforming product, and meeting its quality objectives and customer requirements.
EQUIPMENT & FACILITIES: PERSONNEL: CONTROL PROCESSES:
What equipment and resources are required? Review employee skill lists for the process. Are there How is the process defined and who is responsible? Is equipment suitable and properly maintained? lists of skills for each position? Do they show enough How are customer requirements defined? Is the work environment maintained? detail? This is often a finding, where lists are generic What specifications apply defined? Is there evidence of appropriate maintenance of all with inadequate detail. Training is a key process of What objectives and targets apply process? equipment used by this process? any system. Are there particular skills you want to What controls/check points are there? evaluate? What acceptance criteria exist?
PROCESS INPUTS: PROCESS NAME/DESCRIPTION: PROCESS OUPUTS:
What triggers the process? What steps are involved in the process? What is the product produced by this process? What inputs are required? What happens at each step in the process? Are product measures in place to ensure that Where do the inputs come from? What documents and records are generated? product meets requirements? Are they received in a timely manner? Is the process implemented in accordance with How are processes measured? Are they fit for purpose? procedures, instructions or plans? Are product and process measures achieved? Are controls applied as described? What feedback is received from customers?
INSTRUCTIONS & PROCEDURES: SUPPORT PROCESSES: KEY PERFORMANCE INDICATORS:
Review the documents that describe and control the As you audit, you will see how it connects and Review metrics and performance with Managers, process. Review all the important steps and activities interacts with other processes. Interactions with Supervisors and operators. They should know how of the process being audited. This info must be other processes are always important. As you audit things are running, objectives, customer issues, documented within the QMS. Evaluate how the, you will see how it connects and interacts with problem areas. If they do not, the requirements were effectively the process flows through the steps. Do other processes. Audit the relevant links to related not met. Is there evidence that quality objectives and you see roadblocks or issues? processes and support processes. targets affected by this process are being achieved?