And they said it couldn’t be done

More insight into AuditOne, the new standard that could significantly reduce auditing time and compliance effort.

When I attend industry events, such as the recent CPA Annual Meeting in February, I hear frustration among suppliers with the state of our industry. Sometimes it’s in one functional area or another. Often it’s with regard to a challenge or issue that either requires a significant change in process within branded marketing companies (customers); or requires industry leaders to agree on a common approach — a daunting task. And, the refrain most often is, “When pigs fly,” often followed by a sigh.

I am delighted to report, that in one case, those chubby pink swine have, in fact, started to sprout wings, much to the surprise and amazement of most within the industry.

In January, F4SS announced a new program called AuditOne. This is the result of a collaboration between Procter & Gamble, Unilever, Johnson & Johnson, L’Oreal and Estee Lauder led by F4SS. AuditOne is a global, harmonized approach to cGMP audits.

With AuditOne, suppliers contract with one of the approved audit firms to conduct an audit to the designated standard for the category they are producing. The auditor posts the completed audit to a secure site; the supplier can designate which customers are authorized to view the audit, satisfying cGMP requirements for the year for participating customers. The program has launched with six branded marketing companies who recognize AuditOne, and they are among the largest in the industry. We expect many more to endorse the program as it rolls out.

Participating companies approved the designated category standards. In some cases, existing standards met customer requirements as-is (cosmetic ingredients, vitamins/nutritionals, and Rx: APIs, excipients and basic chemicals, primary packaging and labeling). In other cases, addenda or revisions will be required (Home/Laundry, Packaging, Secondary Packaging). For some categories, there is no current standard, and they will be developed. Customers are working collaboratively to ensure standards meet requirements for all AuditOne participants.

AuditOne represents a dramatic improvement in the cGMP audit process for the CPG/FMCG Industry for all participants. With AuditOne, there will be compliance visibility throughout the supply chain like never before. In turn, the expanded quality audit base will reduce risk industrywide.

In addition, there will be clear focus on one standard for each category, as opposed to one for each customer, so customers will be able to reallocate resources and potentially focus on more value added activities. And suppliers will be able to host one cGMP audit that satisfies the requirements for many, if not most/all, of their customers instead of hosting multiple redundant audits. Additionally, suppliers will be able to demonstrate capability to potential customers by providing access to the audit without the customary wait to be audited by customer colleagues. Ultimately, the rising tide will raise all boats to deliver high quality standards for the consumer.

AuditOne is currently being piloted with material and component suppliers in the non-foods segment. It is expected to be rolled out broadly to all non-foods material and component suppliers by mid-2016, and expanded into contract manufacturing and packaging pilots toward the end of 2016.

While leading F4SS I have seen many things I didn’t expect to see in my lifetime. This has to be the crowning achievement. We are fortunate to live in an era when customers see the benefit of collaboration to create value for the entire industry. With this development, who knows what may be possible!

Lisa Shambro writes this column on matters of cost containment relating to contract packaging services. Contact her at lisa.shambro@f4ss.org

See Contract Packaging’s news for details, as well as the original announcement at f4ss.org/photos/AuditOne_PR_1-27-16.pdf. Still more details can be found at www.f4ss.org, AuditOne tab.

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