CPC has built a successful company by closely collaborating with our customers. That holds true whether we’re developing products or implementing processes like quality audits.
Customers use audits to ensure that CPC is adhering to defined requirements and has the proper controls in place to deliver the expected outcomes. Requirements come from a range of sources: customers’ quality systems, CPC’s Quality Management System (QMS), and industry quality standards such as ISO 9001 and 13485, which are part of CPC’s QMS.
Customers and CPC team up to develop an audit plan that will yield the information customers need in an efficient, timely and comprehensive way.
A product or system is only as good as its components
CPC products are incorporated into other products or systems. The function of our connectors, for example, is often critical to the overall performance of a finished product. If a connector leaks, is difficult to use or install, or doesn’t work properly with the application’s required performance characteristics (e.g., temperatures, flow rates, chemical compatibility), the whole system may function suboptimally. You can understand why customers take their supplier audits seriously, as do we. It’s an essential component of ensuring everything works as intended.
“If you don’t know where you’re going, you’ll end up someplace else.” (Yogi Berra)
The audit process starts with clear communication and setting specific objectives. Thoughtful planning and execution create successful audit processes. CPC focuses on fully understanding what is needed during the audit so we can deliver exactly what the customer wants.
Step 1: The customer supplies a detailed agenda. From that, we create a mutually agreed upon schedule to ensure we have the right resources in place on audit day.
Step 2: CPC lines up the correct subject matter experts. There are many common elements among audits like sharing Quality Management System information or discussing adherence to ISO standards. Each customer, though, can have slightly different needs regarding subjects into which they’d like to dive a little deeper. CPC ensures our experts are available to answer questions, show systems or documentation, or explain processes in detail.
Step 3: The team remains focused, attentive and takes the process seriously. Audits require significant time and personnel for both CPC and the auditing organization. Our goal is to thoroughly and efficiently address matters of interest. We strive to be courteous and cooperative. The agenda also sets the pace for the audit. An auditor may only have a few hours in which to cover a great deal of material, so being mindful of time is important.
We want auditors to obtain the content they need to satisfy their requirements. If a team member is asked if CPC is ISO 13485 certified, the answer is yes. An auditor may not want any more information than that. Clear, concise answers are best. If an auditor wants more detail, he or she will ask.
Step 4: We refer to, and rely on, CPC’s robust quality systems and procedures. When we’re asked about the work we do, we can—and should—refer to documented procedures. Quality isn’t left to chance. It is approached in a methodical, documented and vetted way, all of which is reflected in our Quality Management System, change control process, work instructions and standard operating procedures. In an audit, a good guess is a bad idea. Everything is documented and available so if a team member doesn’t immediately have an answer to a question posed by an auditor, a supervisor will.
Step 5: Perfection isn’t required, but responsiveness is. Many audits result in “no documented findings.” In other words, all questions and matters were addressed to the auditor’s satisfaction. Occasionally, an auditor will identify a necessary change. To both address the audit findings and to engage in continuous improvement, CPC works to quickly and thoroughly resolve any issues.
As always, CPC’s goal is to work collaboratively and collegially with our customers. This includes audits. Both we and the customers we serve benefit from being confident in CPC’s quality processes and procedures. It’s all part of earning and maintaining customers’ trust and business, both today and into the future.
For more information on CPC’s Quality Standards refer to our Quality and Compliance Resources.