How do you choose the best audit method for your quality management system?

In my experience, one of the best methods for measuring your QMS is to apply for the Malcolm Baldrige National Quality Award. In the United States, it's the highest quality award an organization can receive. But the point of the Baldrige program is for you to understand how you manage quality, not to win an award. You learn while you apply for the award. The framework first identifies 7 critical areas in which you should strive for excellence. From there, you follow a procedure to evaluate and improve your processes in three distinct stages. When you complete this evaluation, you have identified your key strengths and you can build on those strengths. Even more important, you now understand areas where you can improve even more.

The most important part of the audit process is effective closure of open issues. Too often the objective of management is to close the CAR's quickly instead of effectively. It is based on a calendar rather than the event. That leads the audit program to do 2 things that drive real improvement. Every audit plan needs to include review of previously closed CAR's. The other action is to evaluate the repetitive occurrence of issues per each clause. If you are identifying repeat issues, the corrective action are not taking a holistic approach to eliminate systemic issues.

Internal audits, as you describe, can be valuable and impactful. Issues around compliance are important, but for me, "effectiveness" is key. That supposes however that there is clear understanding around what a process is trying to achieve and adequate measurement to have some idea of how things are going!

Our small company uses an independent auditor to perform our internal audit. We associated ourselves with our State's (NH) Manufacturing Extension Partnership, a group supported with government funding to help reduce the burden for small companies to become compliant in ISO-9001 standards, among many other supportive endeavors. Giving our auditor access to our Google Drive file structure where our QMS is maintained made it very easy to conduct remote internal audits which helps reduce costs. Using Drive to maintain the QMS is a highly efficient strategy and has automatic version control built into every maintained file. Using these methods has helped streamline our operations and maintain compliance. Wouldn't do it any other way.

I would focus on internal audit more and ensure that the organization is fulfilling with stakeholders, clients, vendors, external auditor,…..ext requirements. And if we focus on the rest of the mentioned audit types in articles they all fall under internal audit process.

My opinion is biased about supplier auditing, therefore, to achieve relevant results, it's necessary not only to select companies with a good track record for this purpose but also to analyze which parameters are relevant to your company. Simply auditing for the sake of auditing is more of the same; as contractors, we need to provide the right directions for the audit to be faithful to reality.

Read the Standard, cover to cover. The devil is in the detail. Make a Compliance Checklist, to ensure that you have covered every item. Add hyperlinks within the Compliance Checklist to your support documents, for ease of access during the audit. This will make for a less stressful audit and will show you are fully audit-ready to yourselfandthe auditor. You may have little choice with particular customers, as to which standard you choose for your External Third-party.

Pay close attention to "special processes" - processes whose function you cannot verify until it is delivered. Sterilization cannot be be verified because testing them would contaminate them. For these processes, it is important to focus on making the process very capable, and create a robust sampling strategy.

Layered Process Audits, or LPA, are a great method of verifying that your internal expectations are understood, documented in a controlled fashion and actively part of the culture. The auditors themselves, coming from multiple areas in your hierarchy sow the seeds of compliance as they audit for it. Also, the metrics are basic and ownership of the data can be given to technicians who demonstrate an interest in becoming engineers.

Process based audits are effective but can become irrelevant quickly. If items identified during the process audits become recurring issues without any action, the audits become a check the box activity. Ideally, adding top level leadership to the process prevents this from becoming a Non-Value added acivity.

Product audits are a successful outcome of an effective process to ensure quality, reliability and safety of the product. It can help understand if characteristics are measurable and achievable and avoid waste and improve efficiency.

Use complaints as a lag indicator of what the gaps are in your product. Work from there, using your Product Specification as the minimum basis. How else do you confirm compliance to your Specification?

System Audits or desktop audits are generally ckecklist based. Compare what is actually happening to what is documented. Make sure they are not just a tick-and-flick. Do them one procedure at a time and plan the reviews/audits so you don't have to drop out of work to cram 2 days of System Auditing before an External audit.

The most useful way to audit the QMS is using ISO 9001 as the criteria for the audit; and we can use the ISO 19011 as the reference for audit methodology. It's very easy to find those ISO standards via Internet (you can ask me for a copy free, because I believe that those documents may be shared to help more and more auditor, or you can study any Lead Auditor class, the trainer will provide you one copy). Just follow the step on 19011, and you will have a audit which effectiveness and efficience; believe me, and believe the author of 19011!

The most useful way to audit the QMS is using ISO 9001 as the criteria for the audit; and we can use the ISO 19011 as the reference for audit methodology. It's very easy to find those ISO standards via Internet (you can ask me for a copy free, because I believe that those documents may be shared to help more and more auditor, or you can study any Lead Auditor class, the trainer will provide you one copy). Just follow the step on 19011, and you will have a audit which effectiveness and efficience; believe me, and believe the author of 19011!

Your system audits can point out if the audits are done precisely like it suppose to happen or if something is left out that cause it to show the weaknesses. The system audits points out the weaknesses and you see the strengths.

Keep it simple. If you prefer checklists, use them. If you prefer to walk the System Plan, make it visual and use the Flow diagram. Involve other key stakeholders of the business in the audit process, auditing outside their area of work so you get fresh eyes on the process and documentation. It all works.