DITA Voluntary Member Audit Program (VMAP)

Scope: The Voluntary Member Audit Program is for members that elect to have their compliance management systems measured against a protocol recommended by DITA members.

Objective: The VMAP has been established as an optional mechanism for member companies to demonstrate a level of compliance recommended by DITA as stated in the association’s Code of Conduct. (The VMAP also recognizes that because there are other audit programs used by members to validate their compliance management systems, the VMAP allows for another program to be submitted as an alternative method of meeting the VMAP objective.)

Nature of Audit Program

• Audit is completely voluntary
• Member pays all costs of audit
• Auditor must be preapproved by DITA (a list of recommended auditors is attached, however any member can apply to “DITA consulting board” to have the credentials of any third party auditor reviewed).
• The program would be managed by committees appointed by the Executive Committee.

Modules of Audit Program

There will be two separate modules in the DITA Program. Members can volunteer to participate in none, one or both modules.

1. Product Compliance System Audit
2. FDA GMP Compliance

Equivalent Programs

Members can apply to a committee designated by the executive committee to review company programs such as Responsible Care programs along with audit history or any third party audit. A decision will be made on whether the program is equivalent for one or both modules. An equivalence decision will be good for five years from the date of the last audit.

Execution of Audit

1. Product Compliance System Audit

This phase of the audit examines written documentation for assuring product compliance with applicable Chemical Control Laws and FDA regulations. The auditor will determine which laws and regulations are applicable to the product line by examining sales records and technical and promotional literature. The audit will be limited to review of documentation of procedures to collect and maintain files of applicable compliance documentation from suppliers, coordination of latter requirements with the purchasing function, assigning and checking CAS numbers for manufactured chemical substances and meeting established food grade and food contact grade specifications and assigning specifications for food grade and food contact grade for components where established specifications do not exist.

2. FDA GMP Compliance

This phase of the audit is an on-site check of written GMP procedures and execution of procedures for all blending and manufacturing sites, including toll or contract manufacturing sites.

Elements of the audit include:

1. Review of written procedures for adequacy against 21 CFR Part 110 and 174.5, as applicable

2. On site inspection to review adherence to procedures

3. Interview of plant managers and workers to review adherence to procedures

3. Auditors report to DITA

Upon completion of the audit, the auditor will send a letter to DITA reporting on the results of the audit. The results of the audit will be considered acceptable if the auditor can make the following statement:

We have conducted the DITA [name module] Audit on [name of member company].  We found adequate compliance systems exist to manufacture products under FDA GMPs (21 CFR Part 110 or 174.5, as applicable) [and/or] in compliance with global chemical control laws (e.g. TSCA, DSL , EINECS/REACH as applicable) and/or FDA food additive and food contact regulations (as applicable).  Minor defects identified in the audit are being cooperatively addressed by [name of member company] under our supervision under a reasonable time line.

If the auditor cannot make this statement, the member has the option of continuing the audit until corrections can be made or withdrawing from the audit program.

(Adopted by the DITA Board of Directors, February 5, 2009)

DITA Voluntary Member Audit Program (VMAP)

Member Company Links

Bluestar Silicones

Dow Chemical

Emerald Foam Control

Evonik

Harcros Chemical

J.M. Huber

Ivanhoe Industries

Kemira

Munzing

Organic Defoamer Group