PCB007 Magazine

PCB007-Aug2024

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62 PCB007 MAGAZINE I AUGUST 2024 manufacturing process against your own inter- nal procedures, standards, and work instruc- tions. If your company operates by industry standards, add those to your checklist. It is best practice to perform Process Verification or Surveillance process audits once per quar- ter. As you collect and analyze data from the checklist, you can determine the most benefi- cial internal audit frequency moving forward. Let data drive the decision on audit frequency. Do not base it on opinions. Going All the Way Once you have determined your internal manufacturing processes and have met your goals for the Process Verification or Surveil- lance process audits, you may opt for the next step, which is to have a third-party auditor from an outside company perform a full man- ufacturing process audit to industry standards and your internal procedures and work instruc- tions. e focus must be on the manufacturing processes, not your quality standards. Most companies have ISO certifications already in place that cover most quality concerns. e third-party auditor must cover the same processes as the Process Verification or Sur- veillance process audit, but he or she will dive deeper into each manufacturing process. In this audit, objective evidence will be required. Instead of a yes/no checklist, the third-party auditor should score each audit question to determine the level of compliance. Using a 0–4 point scale is common (see table below.) Any scores below three (3) require a written corrective action that must be documented to prevent reoccurrence. At the end of the day, you want your manufacturing processes scored at a three (3) or a four (4). e factory will need to prioritize and be aggressive to solve and close out all findings. IPC's formal audits are confidential and allow time to make all correc- tive actions, with qualifications good for three years. However, the frequency you choose for your third-party audits should depend on the number of findings and how long it takes to close them out. If there are no findings that require corrective action, some companies opt for an annual audit, while other compa- nies may choose to follow an every three years schedule. Once again, it is important to let the data drive your decisions. What About My Employees? What are the benefits of putting your employees through process audits? Too com-

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