CDS AQS Articles

When I walk into an organization and see hundreds of procedures, work instructions, forms, and other controlled documents, one of the first things I look at is the size of the company. How many employees are there? What does the organization actually do? What is its scope? Because sometimes the amount of documentation simply does not match the organization I am looking at. I have seen relatively small organizations where employees are effectively surrounded by procedures and work instructions. There may be five or six documents governing the work of every employee in the company. When I see that, I can almost guarantee we are going to find another problem. People do not know all of those documents exist. Some are outdated. Some contain requirements duplicated somewhere else. Some no longer accurately describe the process. Employees stop using them and begin relying on tribal knowledge. Meanwhile, the Quality Manager is overwhelmed trying to maintain a documentation ...

I am seeing more organizations point to an external audit with very few nonconformances and several observations or opportunities for improvement as evidence that their quality management system is effective. Management is relieved. Employees are congratulated. The audit report becomes evidence that the organization must be doing things right. Then I start looking at the business. On-time delivery has been below target for months, sometimes years. Customer scorecards remain red. Key performance indicators are flat or declining. Customer complaints are increasing. Internal corrective actions are surprisingly scarce. In some cases, when you look deeper, problems are being handled informally or are not being documented at all. That raises a question leadership needs to be willing to ask: If the QMS is performing so well, why isn't the business performance showing it? An External Audit Cannot Tell You Everything This is not an argument against external audits. Certification an...

A due date is not evidence that a corrective action worked. Neither is a revised procedure, a completed training record, or a green status indicator on a corrective-action log. Those items may show that someone completed an assigned task. They do not necessarily show that the organization understood the failure, removed its cause, or reduced the risk of recurrence. That distinction matters because a prematurely closed corrective action can make the management system look healthier than it is. The record says the problem is resolved. Operations may already be dealing with the same weakness under a different part number, customer, shift, supplier, or process name. ISO 9001 and AS9100 require organizations to respond to nonconformities, address causes when corrective action is needed, implement appropriate action, and review effectiveness. They do not prescribe the five-question format below. This is a CDSAQS professional framework for making the closure decision more disciplined. It s...

I have seen companies use one risk register for everything. The register may look complete, but when I begin asking questions, the company often cannot clearly explain the difference between organizational risk and operational or product-related risk. One line addresses losing a major customer. The next addresses a shortage of qualified inspectors. Another addresses a drawing ambiguity that could produce nonconforming hardware. All three matter, but they do not belong to the same management conversation. This is where many organizations create confusion. They use the word risk as if every risk has the same owner, the same review cycle, and the same control method. Some build one large register that becomes difficult to manage. Others create several disconnected registers that never inform one another. Both approaches can create documentation without necessarily improving the decisions that protect the business and the product. The misunderstanding I encounter most often is the ...

If your first response to a quality problem is to blame the Quality Manager, you may be looking in the wrong place. I have reviewed audit histories where one Quality Manager was replaced by another, and then another. The names changed, but the findings did not. In one case, a certification audit produced numerous nonconformities. Top management fired the Quality Manager because they believed that person was the root cause. The next Quality Manager continued writing internal nonconformities, yet the underlying issues remained. At the following external audit, the same problems were still present and the findings were escalated to major nonconformities. That Quality Manager was fired too. At some point, repeated Quality Manager turnover stops looking like a personnel problem. It starts looking like evidence that leadership has assigned responsibility for the entire quality management system to one person and then blamed that person when the rest of the organization did not perform. Th...