FAQ — Standards Questions
What is the current scope of AuditOne audits?
The initial standards include raw materials and packaging in the FMCG/CPG non-foods industry. Within nonfoods the standards working group is currently working on standards for materials in vitamins/nutritionals, home/laundry, and contract manufacturing. In addition, we have a working group, Project LInkage, exploring the possibility of AuditOne for food. Finally, brand owners have expressed an interest in harmonization in other areas beyond cGMP compliance.
If a supplier makes multiple materials in different product categories, do they need to have audits in each product category or can they just pick one standard?
During the onboarding process, organizations will choose the highest applicable standard for an audit. This will eliminate the need for multiple audits within a segment (e.g., materials, packaging).
Will each brand owner define which standard they require supplying plants to be audited to?
Yes. The standard is based on which category of products are being produced by the facility. All participating brand owners have aligned on one common standard for each category.
Who do we contact to find out the highest standard for our product set?
The category standards can be found here (link).
Why are there addendums to some standards?
In cases where the basic standard does not meet brand owner requirements. An addendum is developed to close any gaps.
Will the standards ever change?
They may be revised as regulatory requirements and/or brand owner requirements change from time to time.
Can organizations suggest a different standard?
Yes, anyone can submit a suggestion here (LINK) to make a suggestion. The standards review working group will review all input and feedback.
What standards will be on the platform next?
The standard roll out schedule will be determined by the brand owner standards working group which will be determined by collective brand owner priorities.
GFSI also supports FSSC22000. Why are you excluding this?
Most standards are by category. There is a hierarchy of standards and recommend customer to choose which standard is best for them.
This standard is accepted globally for food safety but it is not accepted for non-food Quality standards. We are in the process evaluating the opportunity to applying AuditOne to food. There is also a standard in a pilot phase.
I am a distributor of ingredients to the personal care industry and do no manufacturing, what sort of a standard would I be audited against?
We currently do not have a standard selected for distributors, however, the manufacturers you represent should be your tier 1 suppliers on the platform and you should require that they meet the AuditOne standards as required.
Why is Audit One determining the requirements and not customer brand owners? Our ISO, GMP, SEDEX, etc. programs should already be acceptable.
The brand owners have harmonized on the standards. The standards selected or modified now reflect the quality assessment that the brand owners agree meets their compliance expectations.
How does the Audit One compare to ISO9001? Or FSSC 22000?
It was determined that ISO 9001 was not sufficient as a standalone standard to meet our brand owner expectations for compliance assessments. There are elements of ISO 9001 embedded in many chosen standards. The standards selected for the harmonization effort are more in-depth for manufacturing operations.
How does this differ from the existing food standard group auditing standards (e.g. FSSC22000, BRC)?
The steering team evaluated standards. Where they met expectations they were accepted without change. Where they were seen as lacking (not sufficient depth) changes were made by adding additional modules or working with the standards organization to develop a standard that met all brand owners expectations. CBs provide Objective Evidence to ensure audit reports can be closed
Does this apply to APIs?
Yes, the program covers Pharma, Cosmetics, Home and Laundry.
How is confidentiality handled? For example, non-disclosure agreements? Site appears to be asking for information we generally consider company confidential.
The AuditOne Platform allows you to control who has access to your data. Think of the platform as a bank, the security permits you access to your information and allows you to share with only people/organizations you specify.
I’ve heard BRC referenced, but is the ISO 22716 cGMP also part of this program?
Right now, the program is focused upon raw material and packaging suppliers. ISO 22716 is the harmonized standard chosen for Cosmetic 3rd party manufacturers (contract manufacturers).
What is the standard applied for suppliers of Fibers & Non Woven?
If these items are considered packaging materials then the packaging material standards will apply. If the materials are used in a Pharma application ISO 15378 plus ISO 9001 will be used, for cosmetics BRC V5 packaging standard and AuditOne AVM will be used.
What is your expectation if we are already certified to a standard other than the one recommended by AuditOne?
Brand owners will accept only audits meeting the AuditOne program requirements in terms of both the standard and the CBs conducting the audit.
For direct packaging suppliers, how does this audit address the challenges of a one size fits all audit? By that I mean too many times audits are focused on ingredient suppliers and therefore have a lot of questions that do not apply to packaging suppliers. For that reason, my company has started certifying plants to the IFS PacScure standard for packaging manufacturers. Was this standard considered in the development of the AuditOne auditing format?
We have chosen a standard for each category of raw materials – there is also a hierarchy of standards – the expectations are that a supplier will never have to engage in more than one audit annually – these categories and hierarchy can be found at www.auditoneglobal.com
Can we see an audit outline since these audits are 3-5 days?
Yes, the standards can be accessed from a link (LINK HERE) with the exception of the ISO standards (who does not publish their standards).
If we are being audited by BRC on Standard 7, does Audit One still apply?
The BRC standard selected is BRC Packaging V5 plus the AuditOne AVM. It is known as the BRC AuditOne Packaging Standard. Standard 7 will not apply.
With BRC being more Food related and we currently don’t supply this market, will this be required for all packaging suppliers, we did review this one but went with ISO 22716 per Unilever requirements?
The BRC Standard is the packaging standard – Unilever will accept all AuditOne standards as meeting their quality assessment criteria.
IFS PacSecure is a recognized global packaging standard by GFSI. Is IFSPacsecure acceptable to F4SS as an alternative to BRC? IF not, why not?
AuditOne is being launched with the BRC Packaging standard V5 and AuditOne AVM- the program governance requires annual standard review –the steering committee will review the IFSP standard at the next standard annual review. If a change is made the AuditOne governance requires a comprehensive change control process.
You have stated that API’s are covered, but have not mentioned a standard that applies to active pharma ingredient cGMPs. What standard will AuditOne be auditing to? I am not aware of an external auditing body that covers pharma cGMPs – or not one that has been recognized (in my experience) by customers.
The AuditOne brand owners have chosen ICH Q& Step 4 plus EMEA 410/01 (Rev 2) as the API standard
We provide tube packaging as one of our offerings, what standard must we meet for the audits? Some of the information I received states ISO 15378 for Primary packaging. This is a challenging pharma standard.
For tubes used in pharma applications the ISO 15378 standard is required, for non-pharma products the BRC packaging standard plus AuditOne AVM can be used.