AbstractAbstract: It is reported in the literature that the organizations which implement ISO 9001 quality audit are able to demonstrate the effectiveness of their auditing of conformance, but they may fail to achieve their objectives in terms of their auditing of performance, risk management (RM) and improvement in combination. Most of the previous suggestions to overcome this problem were to: 1) focus on processes in addition to ISO 9001 clauses; 2) apply the principle of ‘Process Approach’ of the ISO 9001 Standard by integration of its risk based thinking concept (RBTC); and 3) apply the approach of Lean Six Sigma (LSS) by integration of its related tools. However, it is revealed that the integration of these approaches within audit also has limitations, such as: 1) the possibility of not auditing the most important things; 2) the desire to foster programs for RM and LSS; and 3) the need to assign auditees and auditors knowing the RM and LSS.
In response to most of these audit limitations, searching for a method that may have the potential to utilize the ISO 9001 Standard in a different way of auditing becomes vital. So, a conceptual audit framework (CAF) was developed, it suggests the selection and integration of twelve management tools (MTs) which are related to the seven quality management principles (QMPs) of the ISO 9001 Standard. Subsequently, a preliminary audit framework (PAF) was developed. It includes the questions and guidelines that are based on the CAF and connected with the complaints, practical needs and results of the review of the previously approved documents of the concerned organization. This PAF was thoroughly tested and validated by a further mixed methods study including eleven internal audits, two management reviews (MR) and three workshops. Also, the ISO 9001 Standard and its related guidelines were reviewed to determine the gap in relation to the enhancement of the audits and its PAF.
Applying this PAF indicated that in order to help organizations to audit their performance, RM and improvement in combination, they need to; 1) change their audit approach from ISO elements to ISO QMPs, 2) integrate the MTs that are related to ISO 9001 QMPs within the phases of audit, 3) perform pre-audits in the form of self-auditing, 4) induce auditors to learn all tools to determine the ideal tools for particular situation, and to attain the skills needed for assertion and sampling, 5) audit each department in combination with its internal customer, 6) involve their auditors in problem solving, risk identification and coaching, 7) Perform MR prior to closing the audit, and 8) develop qualitative metrics to measure the performance of their audits. Finally, an auditing framework was developed to meet these needs. It includes the PAF’s questions that led to the discovery of major, valid, factual, chronic and systematic audit findings.
|Date of Award||Mar 2019|
|Supervisor||Ashraf Labib (Supervisor) & Barbara Savage (Supervisor)|