Elevate quality and keep your business aligned with industry standards
Elevate quality and keep your business aligned with industry standards
Published 10 Aug 2021
A quality audit is the systematic examination of an aspect of business to assess conformance with a standard. Conducted by a team of internal or external auditors, passing a quality audit provides assurance that an organization’s products and/or processes are at par with recognized industry standards and compliant with regulations.
This ISO 9001 checklist for first-party quality audits of QMS to help prepare for ISO 9001:2015 third-party audit certification. Conduct a gap analysis in order to understand the current standing of your company in meeting ISO 9001 requirements and where the emphasis of your implementation efforts should be. Examine if the context of the organization, planning, operation, quality control, and product improvement complies with the ISO standard. Use iAuditor to generate efficient on-site reports and assign corrective actions to appropriate team members.
Quality audits are vital to any business because they provide the opportunity to improve processes that can result in better products and services. Passing quality audits allow businesses to operate with the recognition that they are aligned with industry standards (such as ISO-9001) and they can partner with other organizations with shared expectations on quality.
In this article we will discuss:
As a systematic process of determining an organization’s alignment with industry standards, a quality audit follows these 5 stages:
Preparing for an audit entails the forming of an auditing team with an audit plan, identifying audit objectives, determining the scope, knowing the audit criteria, preparing audit checklists, and informing the auditee or client (if third-party auditor) of the timeframe of the audit to be conducted.
The audit is conducted by the team of auditors executing their tasks such as information gathering using the quality audit checklists and other work documents they have prepared.
Audit findings are analyzed and submitted to the auditee, providing feedback and recommendations as well as any corrective actions that the auditee needs to work on in order to meet the standard.
Corrective actions are the responsibility of the auditee and are intended to address gaps in conformance with standards.
The follow-up stage involves the auditor checking on the auditee’s progress on working on the corrective actions. It determines if gaps have been addressed by implemented corrective actions and the organization’s status of compliance after implementation.
|Quality Control (QC)||Quality Assurance (QA)|
|QC is the process of ensuring that the quality of a product or output is meeting a desired standard or performing within acceptable parameters.||QA is how the quality of processes, usually involved in creating a product or output, are maintained at a desired level.|
|Defects are identified and addressed after the product is made.||
Identify and work on process areas for improvement in order to prevent defects.
In short, QC is aimed towards the end product or output while QA looks at the processes involved in manufacturing.
When it comes to QC audit and QA audit, both involve the same audit process conducted by auditors who are tasked to determine if products (QC) or processes (QA) are meeting set standards.
Quality audits are conducted to discover failures or opportunities to improve in order to meet quality standards. Here are 3 of the common failures encountered in quality audits:
Some examples of technical failure in quality audits come in the form of unorganized documentation and the state of a facility. Providing proof of consistent quality requires ample and organized documentation. Technical failure in the factory or facility can be a result of the poor layout of the production floor and the quality of equipment used.
Social failure usually involves non-compliance with acceptable working conditions. Workplaces that don’t meet safety regulations and have unacceptable labor practices like child labor are glaring fails in quality audits. Poor labor practices of suppliers or anyone involved in the supply chain can entail social failure for the organization being audited even if they are not directly responsible for the deficiencies in labor practices.
Another example of social failure can be something as basic and crucial as the proper wearing of personal protective equipment (PPE) in the workplace. Proactively reinforcing safety practices can help avoid social failures in quality audits.
Businesses have a responsibility to minimize their negative impact on the environment. Organizations are expected to have processes in place for proper waste disposal and storage of toxic substances. Lack of controls to mitigate environmental impact can result in quality audit failures.
According to the American Society for Quality, there are 3 types of quality audits: process audit, product audit, and system audit.
Process quality audits examine process conformance to set standards. This type of audit may include auditing resources as well as defined requirements within processes such as weights, times, and other measurements. Process quality audits also assess the effectiveness of process controls through work instructions, employee training, and more.
Product quality audits examine output such as products or services to determine if they are performing according to customer specifications and are meeting quality standards.
System quality audit examines the quality of a management system to ensure it is indeed effective and performing according to expectations. Examples of system audits performed are for examinations of quality management programs, environmental management system, food safety management system, and safety management system.
There are different types of audits according to who performs them and the intention for conducting the audits.
First-party audits are conducted by the organization itself usually to assess its current standing against an existing standard in order to discover gaps that can be corrected. Usually performed in preparation for getting a third-party audit for certification, this internal quality audit is done by employees and is designed to be objective in order to uncover areas for improvement.
First-party audits also help establish benchmarks of the internal audit activity that can be used to establish metrics. Over time, these metrics will indicate improvement in areas of partial conformance or nonconformance with standards and successful practices.
Second-party audits are conducted on suppliers by a customer or by an organization on behalf of a customer. It is conducted as a contractual obligation for a transaction that determines purchases or deals to be made by a customer.
Third-party audits are performed by recognized independent audit organizations that are not affiliated with the business being audited. They are authorized to provide recognition or certification that an organization indeed meets a certain standard after being audited.
A quality audit checklist is a tool that guides auditors, quality managers, inspectors, or an assigned person in auditing products or business procedures. It helps assess the performance of established processes and identify any underlying issues that require corrective actions. Performing regular quality audits can help maintain the quality of products, boost business efficiency, and improve business strategies while maintaining conformance with existing standards.
Below are the phases of using a quality audit checklist for quality audits:
Going through quality audits, whether conducted internally or performed by third-party auditors, can be rigorous and require a lot of time, effort, and resources from the organization. Using a quality auditing tool like iAuditor by SafetyCulture can help elevate the way audits are performed while saving time and resources that could be better allocated elsewhere in the business. With iAuditor, quality audits can be improved through:
iAuditor is designed with the auditor in mind and the quality of audits to be performed. Whether small or large team, conduct audits using quality audit templates on mobile devices that can be assigned to and performed by authorized auditors to capture relevant data.
As quality audits are supposed to be performed following a timeline, timely reporting can be challenging especially for particularly tedious quality audits. With IAuditor, detailed quality audit reports can be submitted and filed automatically, saving time and effort for all auditors.
Using all the information collected, iAuditor can provide insightful analytics that can aid auditors in determining the current status of quality which can then help in providing recommendations and identifying corrective actions.
Layered Process Auditing (LPA) is a quality management system in manufacturing that is designed to add layers of protection against critical risks that can lead to rework, customer complaints, costly product recalls, and damage to the company’s reputation. Assign auditors this LPA checklist to ensure that high-risk steps in production do not deviate from set specifications.
A GMP compliance audit checklist assesses manufacturing practices and company adherence to manufacturing protocols. This template can be used by site managers or operations supervisors to help ensure that quality manufacturing standards are met. Use this template for help with the following:
This GMP audit checklist for food manufacturers is based on 21 CFR Part 110 and can be used as a guide when conducting food manufacturing audits. Inspectors can use this to:
Software quality engineers can use this internal QA checklist to ensure that the software in development passes standards set by the organization or regulating bodies. Assess the software’s performance, efficiency, and usability, and check for bugs, deficiencies, and security issues.
The Quality Assurance Standards Audit (QASA) is used to measure and drive continuous improvement on the execution of food safety and cleanliness standards across retail stores. The QASA recognition program recognizes stores that demonstrate an exceptional level of adherence to quality assurance standards.
Use this General Call Center Quality Assurance Form to help evaluate calls and observe if representatives follow standard call protocols. This will help check if call representatives understand customer concerns and offer the most appropriate solution. The QA Manager or QA Trainer can use this to check the competency of representatives and help ensure that the call quality is consistent across operations. This QA audit form can serve as a guide to help with: