Introduction
As the latest
quality management systems are having a process approach, one of the most
important and elementary actions to trace and follow quality is the auditing of processes, in order to determine their effectiveness (e.g. manufacturing process audit).
Process audit is not just a tool or activity to analyse process quality or to find deviations, but a mandatory action at
ISO 9001 certified companies, that has been enhanced further in the automotive industry by
IATF 16949:2016. Te QMC department of
VDA has
even created a separated standard for process audits (VDA Volume 6 / Part 3).
Source: qMindset.com; ISO.org; VDA-QMC.de
TEST ADVERTISEMENT (for temporary testing purposes, source: presse.porsche.de)
Key Features
Such as many other fields in quality management, process auditing is based on common sense. Frequently and properly performed process audits bring several benefits to the
organization, which are:
- Revealing the effectiveness of the audited processes (transparency).
- Supporting control over processes.
- Helping to identify process risks and deviations upfront.
- Increasing the mindset of participants and stakeholders.
- Identifying value adding processes, and those which do not provide value.
- Supporting the management to decide where to allocate resources.
- Reducing scrap and waste, hence providing financial benefits.
- Assisting to spread best practices to other areas.
Various process audit types exist, and the content usually overlaps each other, but the final aim is different.
- Internal process audit: an engineer or a leader performs an internal audit in the organization.
- Layered process audit (LPA): the stakeholders in the organization systematically perform internal audits, with different frequency (for example: the shift leader conducts the audit every day, while
the plant manager performs it once a month). The content, and question list is based on the internal process audit disciplines.
- Process release audit: in this case the customer is auditing the manufacturing process of its supplier. The result of the audit determines the outcome of process release, which can be final approval,
conditional approval, or rejection.
Source: qMindset.com
Hints
The benefits mentioned above are all valid, however it must be known, that only properly performed audits are rewarding, as mentioned above. Those audits, which are being done
only to satisfy the management or the customer on paper isn't worth anything. But what is a "proper" process audit like? Here are some notes:
- The auditor must use the "independence" principle. This means if a manufacturing department leader is having an internal audit on his / her own line, then he / she must act independently and critically
to focus on the findings, and mustn't hide anything from his / her own eyes. In case of 3rd party audits (e.g. system certification audit) the independence is obligated.
- The auditor must request evidences when verbal statement seems not enough. This comes from auditing experience over time, there is no clear recipe.
- It is crucial to win the participants (audited associates) in order to earn their trust. It is suggested to describe the aim of the audit at the very beginning, and to tell the participants, that the
audit is not to punish anyone, rather it is meant to be for improvement.
- By starting a process audit, it is advisable to go through the whole process from incoming goods to final packaging, based on the Control Plan. In addition the PFMEA can give you the focus points, so
using a print-out during the audit is also favourable.
Source: qMindset.com
Summary
- Process audit is a systematic activity to review the conformity of both manufacturing and complementary processes.
- The aim of process audit is to improve and not to blame.
- Process audit is a mandatory requirement in the ISO 9001 standard.
- An open and properly performed process audit is worth more, than a thousand insufficient ones.
Source: qMindset.com; ISO.org
