Whether Quality, Environment, Energy, or Occupational Health and Safety, as soon as management systems are implemented, further developed or certified, one is confronted by a Lead Auditor. But: Organizations are increasingly concerned about the auditor’s performance. Let’s have a closer look at Lead Auditors!
Auditors decide whether the processes conform to what was originally planned in day-to-day business. At the same time, the auditor scrutinizes the existing process flows and tries to identify weak and defective points so that corrective measures can be initiated to improve the process.
For inexperienced Lead Auditors, there are currently two tendencies:
- To start from criteria and ask the auditee for evidence to demonstrate its conformity.
- To start from a process and its risks (6M: man, machine, material, method, mother nature, measurement) to justify the effectiveness of existing practices by comparing them with auditor experience or working instructions.
Neither of them is complete auditing.
Audit findings: superficial, fragmented, hardly any improvement
Many participants who attended an IRCA Lead Auditor Course reported when practicing their recent audit knowledge that they are unsatisfied with the low quality of the findings of their audits. The three most concentrated clauses of nonconformities in the context of ISO 9001 (Quality Management System) are
- operation deviates from work instructions (8.5.1)
- incompetent staff (7.2),
- the document is not signed, or the version is not updated (7.5).
If one more clause could be added, it could be 7.1.5 (expired certificate of measuring equipment). Some auditors are not sure how to assign appropriate clauses to the appropriate findings. If they are not sure, they assign the findings to Chapter 8.5.1.
Management complains that most audit findings are superficial, fragmented, and lack refinement, unlikely to lead to effective performance improvement.
Linking the ISO clauses to processes could be difficult.
On the other hand, when auditors apply the “process approach” to non-production processes auditing from a 6M perspective (man, machine, material, method, mother nature, measurement), the auditee feels invincible and weird. These processes include, such as production scheduling, nonconforming product control, production change, internal audit, etc. Applying the “machine” and “mother nature” to these processes is difficult. The different steps of these processes address fundamentally different clauses of ISO 9001, and many auditors cannot clearly link these provisions to the process steps during the Audit.
The traps for inexperienced Lead Auditors
There are two main reasons for the above phenomenon:
- The Lead Auditors do not understand the intent and purpose behind ISO 9001 requirements.
Of course, auditors know the requirements, i.e., what each “shall” says. For example, 8.4.3: The organization shall ensure the adequacy of requirements before their communication to the external provider. When asking them what “adequacy” means and how to ensure adequacy, the answers are often vague. When they audit 8.4.3, the department manager’s signature on the purchasing order usually is taken as evidence. The non-conformity report frequently points out the lack of signature, and the corrective action is to fill in the signature and to provide training so that the manager knows to sign the order in the future. None of these actions has done much to improve performance, ensure product conformity or prevent risks.
- The auditing trials are oversimplified, and Lead Auditors cannot use multiple audit trials comprehensively for various situations.
There are many approaches to audit trials: clause-oriented, process-oriented, department-oriented, risk-oriented, documented-information-oriented, and performance (or effectiveness) -oriented trials. Many Lead Auditors cannot use them comprehensively but often stick to one of them throughout the audit. In particular, the process-oriented audit is understood as analyzing the turtle diagram (6M) of a process as a whole. Lead Auditors check the six aspects one by one, while each of the specific process steps is neglected. Lead Auditors cannot tell you which step should conform to what requirement, and in which step the non-conformity happens for what reason.
Do you know these challenges from your own company or your own practice? Then learn more about complete IRCA auditing. In the live webinar “A universal method for system auditing – Few tips to improve the quality of quality audit” TÜV Rheinland IRCA QMS Lead Trainer Shaojian Cao will explain in more detail how to …
- … link the criteria with processes.
- … check criteria being applied in a specific process.
- … see through a process to select evidence that can be projected accurately to criteria.
- … what knowledge you should have behind these skills.