The quality audit is a procedure for monitoring and improving all parts of the quality management system based on an independent and systematic investigation. Therefore, a Quality audit is a modern information system that can assess the effectiveness and appropriateness of quality and the effects of these measures should be monitored.
In other words, a quality audit is a management tool with which the management receives information about achieving goals.
There are many ways to classify quality audits, as they can be sorted by scope, by how the audit is conducted, or by who is leading it. This last classification is the most common one as it classifies audits into only three categories: first-party, second-party, and third-party audits.
What are first-party, second-party, and third-party audits?
Internal audits sometimes called “first party audits,” are audits conducted by a company’s quality unit (QA); this serves as a self-assessment to determine how well the quality goals and quality specifications are being achieved and how the standard requirements are being met.
Only the company itself is involved in an internal audit. It is usually carried out by a trained employee who asks colleagues from other departments about the processes. Internal audits are primarily used for self-assessment and promoting communication about how the processes in the company can be made even more efficient.
External audits include what are commonly called “second” and “third-party audits.” This type of audit serves a similar purpose of assessing the quality system, only differing in that second-party audits are carried out by parties with interest in the organization, for example, customers, suppliers, stakeholders, and so on, sometimes they are also carried out by other parties on behalf of the interested parties, vendor audits are also part of this category.
On the other hand, third-party audits are conducted by independent organizations, such as those that provide consultation services, registration or certification of compliance, or by government agencies.
Whichever type of audit you may need, you can also subdivide your audits into other categories to make the audit process more specific, and for it to adapt better to your needs, these could be:
- Product audit
- Process audit
- System audit
The importance of quality auditing
Conducting internal and external audits is not just another requirement that must be checked out to get a certification; the auditing process is vital as it not only provides credibility regarding the quality of a company’s processes and products, but it also helps to:
- Determine the performance of the QM system
- Uncover errors and eliminate them effectively
- Provide objective assessment of the processes and regular procedures
- Check the processes described “on-site.”
- Obtain objective evidence/evidence that existing requirements are being met
- Initiate solution, correction, and improvement measures
- Monitor the effectiveness of the specified measures
- Draw optimization for the QM system from the audit and return it to the organization
Therefore, audits should serve to continuously improve the QM system while offering the opportunity to identify weaknesses that may have arisen over the years. To ensure an audit reaches these objectives, we have to use Audit Quality Indicators (AQI).
Audit quality indicators
Audit Quality Indicators are quantitative measures of the audit process. They provide insights about factors influencing audit quality when assessed with relevant qualitative information. This provides general oversight of the audit, increasing the transparency of the audit approach and providing better information to evaluate auditors.
The most common Audit Quality Indicators are:
- Audit hours by risk
- Use of technology in the audit
- Specialist engagement
- Achievement of the timing of agreed-upon deliverables
- Results of inspections
- Effective and timely communications
What are the four phases of an audit cycle?
The key to leading a successful audit is to be prepared. First, we need to understand the organization’s strengths and weaknesses; with this in mind, set your goals, then list down the steps, time, and resources to achieve them. Finally, share the plan with management.
Understand that an audit plan is not set in stone. Before starting the audit,
- check for any questions or changes, adapt, and remain open.
- During the audit, ask prepared questions and assess compliance.
- Check for improvement opportunities.
After the audit, formulate the audit findings and conclusions and express them in such a way that the auditee does not feel rebuked or patronized. Then, go through all the negative and the positive findings.
During this last phase, verify that all the audit findings have been corrected accordingly and as scheduled.
What is the role of the auditor?
With the decision to enter the audit process comes the need to select suitable personnel to conduct the audit. Depending on the form of the audit, this can be an employee of a company or an external auditor. This auditor team should bring specific skills and competencies to thoroughly examine all aspects of a business, product, or service.
The role and skills that are necessary to conduct a successful audit vary on the role the auditor plays in the audit:
It is the most senior position within a team of auditors. The lead auditor is mainly responsible for planning and managing the audit, leading the audit team throughout the audit process, leading the opening and exit meetings, and handling follow-up communication with company leadership during and after the audit process.
They are a crucial part of the team of individuals who are responsible for determining the compliance of a company, a process, or a product; they are the ones who are responsible for conducting multiple audit processes under the supervision of a lead auditor.
An auditor role requires methodological, technical, social, and personal skills and a good understanding of the industry, product, or organizational specifics to adequately respond to the perspectives of those involved in the audit process and to uncover and communicate any opportunity for improvement in the quality system.
If your auditor team needs to be more competent, this may lead you to a failure to detect inadequacies in your quality system. A good auditor is always looking for improvement opportunities.
Common reasons for quality audit failure
Regardless of whether you are aiming for a certification audit or you need an internal audit to understand the health of your quality system better, here are some things you should be looking out for to avoid an audit failure:
- Unskilled auditor team
Having a team of internal auditors that are inexperienced or who need to gain the necessary skills and qualifications to conduct an audit can leave undiscovered gaps in your quality system if these gaps end up being critical non-conformities. In that case, this may lead you to fail a certification or regulatory audit and rob you of the opportunity to improve your processes.
- Misunderstanding guidelines and regulations
Misinterpreting regulations, norms, guidelines, or even previous audit recommendations may cause issues in your quality system to remain uncovered and unresolved until it’s too late.
- Lack of self-criticism
When using internal auditors, the most significant risk is that they are the same people who created the quality system. They feel pressured by the company’s leadership to produce favorable findings. As a result, these audits don’t raise issues or uncover improvement opportunities. It would help if you had objective and impartial auditors who would search for opportunities for improvement.
Be skeptical if audit results are always positive—audits that don’t report areas for improvement and not good audits.
- No audit objectives
Performing an audit with no objectives is similar to walking in a dark room trying to find a needle. Audit objectives are necessary to guide you and avoid distractions during the audit process to quickly verify the compliance of the department/organization to the defined Quality system. A lack of objectives can lead you to waste resources and leave gaps or improvement opportunities undiscovered.
- Not enough resources
Sometimes resources are scarce to conduct an audit, and thus we tend to prioritize getting on with daily tasks and leave audits to the last minute, or we conduct audits without going too deep into the processes.
If you find yourself in these situations, the best thing to do is to implement a risk management system and conduct a risk assessment. By doing this, you can determine which processes need more attention and reassign your resources to those that require more attention.
Need help planning and conducting your audits – contact us today.
Quality auditing is a procedure for monitoring and improving all parts of the quality management system based on an independent and systematic investigation, review, and evaluation of an organization’s quality management system (QMS). A Quality Audit assesses the QMS’s conformance to company policies, contract commitments, and regulatory requirements.
The primary purpose of a quality audit is to assess the effectiveness and appropriateness of quality assurance measures. Quality audits are an essential management tool to obtain objective evidence of processes. A quality audit should point out system weaknesses, identify improvement opportunities and evaluate the effectiveness of corrective actions.
There are three different types of audits: First-party, Second-party, and Third-party. An internal auditor usually carries out 1st Party Audits; in 2nd Party Audits, there are two parties involved, e.g., a company auditing a supplier; finally, 3rd party audits can only be carried out by external auditors (independent third parties), e.g., in certification audits.
The main types of quality audits are First-party (self-inspections), Second-party (supplier audits), and Third-party audits (certification audits), but there are many more ways to classify quality audits; these extra categories can be by scope (product, process, and system audit), by method (remote, hybrid, and on-site).
Determine the performance of the QM system, Uncover errors and eliminate them effectively, Provide objective assessment of the processes and regular procedures, Obtain objective evidence/evidence that existing requirements are being met, Initiate solution, correction, and improvement measures, and Monitor the effectiveness of the specified measures
The most common quality audits are, for example, internal audits carried out by a trained person of the same company, supplier audits carried out by the company’s customers, or certification audits. Certification companies carry these out to check the standard conformity of the quality management system.
Audit methods are techniques that allow auditors to handle different audits according to standard rules and adapt to obtain all the relevant audit data. These techniques are Inquiry, Confirmation, Observation, Inspection of documents, and Inspection of physical or tangible assets.