THE TOP 10 REASONS WHY INTERNAL QUALITY SYSTEM AUDITS ARE INEFFECTIVE AND HOW TO AVOID THEM : THE TOP 10 REASONS WHY INTERNAL QUALITY SYSTEM AUDITS ARE INEFFECTIVE AND HOW TO AVOID THEM Sidney Vianna June 13th, 2006


Audits are supposed to add value: Audits are supposed to add value Why do organizations have an internal audit program? One of the best <however under utilized> tools for an honest self assessment Societal/stakeholder expectation for reliable demonstration of effective internal controls. A great improvement tool, typically wasted, because internal auditors normally focus on strict compliance with the “command media” Why top management does not value internal audits? Do auditors link the results of the audits to the risks to the business? The old adage of learning to communicate in a way that is appealing to management


Wrong people selected: Wrong people selected People are typically selected as internal auditor candidates for the wrong reasons, such as: The plate least full They work in Quality They are inspectors Do not underestimate the importance of personal attributes: Mature and knowledgeable about business processes ethical, i.e. fair, truthful, sincere, honest and discreet; open-minded, i.e. willing to consider alternative ideas or points of view; diplomatic, i.e. tactful in dealing with people; observant, i.e. actively aware of physical surroundings and activities; perceptive, i.e. instinctively aware of and able to understand situations; versatile, i.e. adjusts readily to different situations; tenacious, i.e. persistent, focused on achieving objectives; decisive, i.e. reaches timely conclusions based on logical reasoning and analysis; self-reliant, i.e. acts and functions independently while interacting effectively with others.


Poor qualifications: Poor qualifications Competence building takes more than simple training Classroom training has it’s limitations Knowledge of the system and associated requirements is VITAL! Mentoring and tutoring can and should be used to improve internal auditor competence


The checklist mentality: The checklist mentality Inhibits the process approach A checklist can be an aid, but it can also be a huge hindrance. The goal of an audit is NEVER to check boxes in a checklist.


Importance and status: Importance and status One of the most ignored requirements of ISO 9001. Why audit all processes with the same frequency and attention? Utilize your resources wisely. Don’t waste time auditing inconsequential processes and adjust the frequency of auditing critical processes accordingly. Adjust your internal audit plan


Monkey sees monkey does: Monkey sees monkey does Emulating, imitating 3rd party auditors Constraints imposed onto 3rd party auditors do not apply to internal auditors. For example, you can challenge your processes not only for effectiveness, but also for efficiency. Don’t mimic external audits. Keep your internal audits focused on your issues.


Chronic delinquency: Chronic delinquency If corrective actions are not implemented in a timely basis, exercise the escalation principle Management Review should be discussing the status of corrective actions On the other hand, question yourselves why some of the managers, responsible for CA implementation are not doing it, promptly. Is there a questioning about the validity of the write ups?


Restricting procedures?: Restricting procedures? Some of the constraints experienced by internal auditors, such as mandatory usage of checklists, are “self-imposed” Evaluate your own internal process and criteria, controlling your internal audits. Revamp it, if necessary You have the latitude to design your internal audit process as you see fit


Not enough planning: Not enough planning Criticality matters Audit activities of significance and consequence for the processes at hand. What are the pressing matters for your organization AT THIS TIME? Auditors need to spend enough time IN PREPARATION for the internal audit, reviewing requirements and indicators of process effectiveness


Comfort zone: Comfort zone Auditors, if left unchecked, will tend to stick to their comfort zone. An auditor that is totally unfamiliar with (for example) Design processes might shy away from performing thorough investigations, allowing, this way, for ineffective processes to go unchallenged. Thorough preparation and mentoring can assist internal auditors in understanding processes well enough for an effective assessment.


Rotating auditors: Rotating auditors If internal audits are seen as “punishment”, people will want the function to rotate. And internal auditors would always be in the early stages of the learning curve Even though most organizations can not support full-time internal auditors Find ways to reward top performers


Outsourcing audits: Outsourcing audits It is always a trade off. You will probably trade knowledge of a Standard for an additional cost Outsourcing internal audits might be beneficial in terms of audit depth and effectiveness, but an outsider will never know as much about the organization as an insider could If you decide to outsource internal audits, make sure that the individual is competent. But also ensure if s/he has the “chemistry” to work with the organization. Auditing requires a lot of “people skills”


ISO APG : ISO APG Most of the advice is aimed at Registrar auditors, but some of the guidance can also be applied to internal audits


The source: The source


Communicating audit results: Communicating audit results Poor example: 3 parts were found in the shipping area with the wrong label applied. Good Example: Despite our persistent problems with over 150 misidentified parts, shipped to ACME Medical Devices in the last 3 months, our most recent audit identified 3 (out of 45) mis-labeled parts staged for shipment to this client. Our sales manager has already been contacted by ACME MD and we believe that the customer might be looking for an alternative supplier at this point.