How can your quality audit checklist meet all relevant quality standards?

Manufacturing Quality audits ensure compliance with set quality standards by assessing processes, materials, and outputs. They involve thorough inspections, testing, and documentation to verify adherence to established quality parameters, ultimately ensuring the product meets predefined specifications and industry benchmarks. Regular audits help identify areas for improvement and maintain consistent quality across manufacturing processes.

A management system (lead) auditor is expected to conduct audits in areas in which he has experience. In this way, more appropriate control of the application substance processes is ensured. The process may be evaluated in depth with the questions prepared by the auditor. In my opinion, the issues that should be taken into consideration when asking questions and preparing a list are: 1. What the company's basic business processes are and how they are designed. Focusing on complex process structures and complex process maps can be seriously challenging. 2. It is important to understand the scope of the company. What their outsourced processes are or what processes they leave out of scope significantly affects the question preparation logic.

The first step is identifying the important quality standards related to the industry in question. There are several standards like ISO, ASME, ANSI etc. After this, delve deep into the documentations of these standards, and use them as baselines to draft your quality checklist. It’s important to also get opinions of other experts to ensure the robustness of the quality audit checklists.

Standards are the backbone of the Quality Management System QMS. So, the standard should be followed at International level and company practice which helps to make a compatible checklist for quality products.

Creating a comprehensive quality audit checklist involves aligning it with industry-specific standards, considering regulatory requirements, incorporating best practices, and ensuring it addresses key quality parameters specific to your organization. Regular updates based on evolving standards and feedback are essential to maintain its effectiveness.

Measure and evaluate whether the planned periodic objectives have been achieved or not and take action to improve where the objective has not been achieved. This is important to ensure process effectiveness in addition to compliance to the requirements of the standard.

At the time, our objective was very simple, to pass an external audit with zero issues. Our internal audit coverage was a lot broader than an external audit.

The objective of a quality audit checklist is to systematically assess and ensure compliance with established quality standards, procedures, and specifications. It aims to identify areas for improvement, verify adherence to regulatory requirements, and enhance overall product or service quality through a structured and comprehensive evaluation process

A quality audit checklist should include all, but not limited to, OTD, Rejection percentages, was the OTD objective met. At the end of the day, are the customers needs met?

The scope of a quality audit should be well-defined and typically includes areas such as processes, procedures, documentation, and compliance with standards. It may also cover product/service quality, risk management, and continuous improvement initiatives. Clearly outlining the scope helps focus the audit on specific aspects relevant to achieving quality objectives.

We had a big team of internal auditors, and used divide & conquer method. We divided the internal audit into different sections, per ISO9001, and each section had a team leader with 3-5 internal auditors.

Quality starts with training of the folks who make the product, day, to day. A strong training program is key to achieving quality product.

When designing quality audit check list, the best practice is to make sure that those check list will match relevan specifications. Regardless if we are auditing a product, a process, a piece of equipment or an administrative system, keep consistency with the goals or specs that originally drive the need of that product of service is going to ensure the quality will service for its purpose.

Measure and evaluate whether the planned periodic objectives have been achieved or not and take action to improve where the objective has not been achieved. This is important to ensure process effectiveness in addition to compliance to the requirements of the standard.

Favoritism is the fastest way to create division among a workforce. The ones who put out and work to get the orders filled, get nothing but more work. I work for a company where an employee told a manager that they weren't going to do what was in their job description. That employee is protected.

This answer is for a medium to large company with fairly developed quality systems. For small businesses, first understand what is the intent off the standard. Most auditors will accept non traditional systems, meaning it does not have to look a particular way if it meets the intent. I prefer a hybrid approach where lean tools are used to manage the quality system. Case in point, create a RACI matrix to administer your communication plan. Across the top of the matrix are the job functions, down the side are the elements of the standard. RACI stands for Responsible, Accountable, Consulted, Informed. By using this matrix idea you accomplish the intent of the standard while creating a functional document thus innovating productivity.

Do not expect checklists to be effective. They are often pencil-whipped and largely ignored. Consider requiring logging of variable data instead of check boxes to reduce data falsification. Keep in mind data logging of variable data can also be faked. In this situation, SPC control charts can easily detect the falsification of variable data.