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Introduction
ISO management systems standards require process-based auditing as the method of
conducting internal audits. Although process-based auditing is widely recognised as
a best practice methodology, it can be a challenge to implement correctly for
maximum benefit.
Steve Barnes, NQA Aerospace & Automotive Operations Manager, presented a webinar on
effective process auditing on 10 March 2016 – this document summarises the key
takeaways.
The bracketed numbers in the model refer to the related clauses of ISO 9001:2015.
A useful tool for developing your audit plan is ‘THE V CYCLE’. Designed to start with
management processes, it guides you down through processes that interact with the
customer and then through the support processes that enable product or service
development and delivery.
An understanding of the context of the organization will need to pervade all of the above
management processes.
Maintenance
Calibration
Training
Problem Management
Corrective and Preventive Actions
I.T.
Each of these processes should connect top management plans with product or service
delivery.
Assessment of these processes in the sequence adopted by The V Cycle mirrors the Plan,
Do, Check, Act (PDCA) cycle.
Following on from the V-Cycle, interviewing top management should be a key element of
your audit. It should focus on establishing a connection between Context, Strategy,
Objectives, Processes, Resources and Outputs.
Awareness of the macro environment and industry sector factors that determine the
external context
Evidence that strategic decisions have been established using rational approaches
The application of ‘Risk Based Thinking’ in the formulation of objectives
Your position in the market place relative to competitors
Consideration of the internal context including systems, skills, shared values
(culture), knowledge
Interviewing top management regarding the above should not require deep analysis – you
are looking for indicators that the above considerations have been factored into decision
making.
7S – Strategy, Structure, Systems, Staff, Skills, Style, Shared values (i.e. Interested
parties, Context of the organisation)
Identifying the most suitable process owner does not always mean going directly to the
manager of a particular process. It could mean approaching an operative who spends the
most time within a process, who may have important tacit knowledge of the process and its
interactions within the management system.
Ensuring that any process critical knowledge that you discover is documented will enhance
the operational integrity of the process.
The CAPDo approach complements the PDCA cycle when auditing a process starting half
way through the PDCA cycle.
Identify the ‘process owners’, then apply the following type of questions:
Who is the customer of the process and what are their expectations?
What are the KPI’s / objectives / targets?
Are these appropriate to the risks?
What risks have been identified?
How do they know the process is working well or not?
How are inputs to various process categories recorded?
Is information correct and up to date?
Are processes effective and efficient?
The Turtle-tool helps to capture and structure the comprehensive range of information
required ensuring that process risk is identified, assessed and eliminated/mitigated.