Design and Development Potential Audit Issue: When Design Contains Sensitive/Confidential Proprietary Intellectual Property Owned by the Customer

API Specification Q1 9th Edition paragraph 5.4 has 7 sections, each of which require you to maintain records. I won’t go into all the details of those records requirements here. You can refer to the Spec if you are not familiar with them.

If you are producing a monogrammed product these records make up what is called the “Design Package”. Among other things the Design Package must include technical specifications including calculations.

In some cases, these technical specifications are provided to you by your customer. These can be valuable and proprietary intellectual property that your company or customer needs to protect, and they might not allow you to have a copy these details at your site.

We’ve recently seen a case where the API auditor wrote a finding because this documentation could not be physically produced at the site. So what do you do to satisfy the requirement, your customer and the API auditor?

Plan ahead for this by scheduling a web meeting with a technical representative who has access to the technical information, and the API auditor. The technical representative can produce the necessary documentation on his computer, share his computer screen in the web meeting and explain the calculation or other technical information. There is no requirement that the auditor touch a piece of paper at your site. Seeing it is sufficient. The auditor will have seen the evidence needed and have the ability to ask questions in the web meeting. If the auditor isn’t satisfied with this, well, we believe he is wrong. You have satisfied the requirement.

If you run into this problem call us. We have helped companies successfully deal with this issue and avoid a finding.

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