OMB Control No. 2070-0178

Approval expires XX/XX/XX 

ATTACHMENT E

DfE Audit Process Guidance for the Safer Product Labeling Program

(DRAFT 8/9/12)

DfE has prepared this guidance to assist our qualified third parties in preparing for and 

conducting desk and on-site audits on DfE-labeled products and partners. For both desk and 

on-site audits, the guidance includes the following elements (in list format): Requisite audit 

materials, audit procedures, and audit follow-up.

 

Desk Audit Process

(based on 4/2011 Edition of the DfE Standard)

I. Materials Required in Advance of Audit

a. A statement that the ingredients and all claims made regarding the Agency’s 

recognition (e.g., use of the DfE logo) comport with the Partnership Agreement or a 

DfE-approved amendment to the agreement; of note, this statement must confirm that 

the ingredients in labeled products are the same as those DfE has reviewed and 

referenced in the partnership agreement;

b. List of all ingredients for each recognized product;

c. Product labels showing use of the DfE logo or mention of DfE recognition;

d. Product or company literature that uses the DfE logo or mentions DfE recognition;

e. Private label (including licensed products) (PL) labels and literature that bear the DfE 

logo;

f. Summary of implementation activities for any continuous improvement efforts as 

required by the Partnership Agreement; and

g. Documentation of education offered to end users of Industrial/Institutional (I/I) 

products.

II. Audit Procedures

1. Request above-listed materials.
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2. For each product, verify that the list of ingredients (including those from third-party 

suppliers) matches the formulation on record and formulation bills of material (e.g.,

batch tickets). Notify DfE of any discrepancies ASAP.

3. Verify correct use of the DfE logo / program name on labels, literature, and the 

partner company website.

4. Request updated PL forms to determine if PL products should be added / removed

from list of labeled products. Verify correct use of the DfE logo / program name on 

PL labels, PL literature, and PL company website(s). Email any PL discrepancies to 

the attention of DfE and Dfesupport@abtassoc.com.

5. Verify that the “Summary of continuous improvement activities” addresses all 

ingredients identified as “target for improvement” in the partnership agreement and 

notify DfE of any unaddressed ingredients.

6. Verify that education is being offered to the end user of I/I products as described in 

Section 3.4 of the Standard.

III.Audit Follow-up and Potential Noncompliance

1. Send written notice to the partner and DfE with a deadline for addressing the audit 

issues or correcting the noncompliance, as applicable.

2. Verify corrective action and send an updated report to DfE (including the root-cause 

analysis, explanation of corrective action, and preventive action plan) within 30 days 

of notifying the client –OR-- Notify DfE that the partner company has not addressed 

the audit issues or not corrected the noncompliance within the allotted time.

3. Submit a “Desk Audit Report” that summarizes all items that DfE should be aware of 

concerning the partner company’s audit, including all items that were acceptable as 

submitted and who performed the desk audit. Note: if there is a formula issue or 

problematic ingredient being used, please highlight this information in an email to 

DfE.

On-site Audit Process 

(based on 4/2011 Edition of the DfE Standard)
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I. Materials Required in Advance of Audit

a. Production records, batch tickets, bills of lading, certificates of analysis, and any

other formulation documentation; 

b. Customer and/or employee complaint file for any potential concerns associated with 

the manufacture or use of DfE products or ingredients; 

c. Records for cleaning, maintenance, and calibration of manufacturing equipment; and 

d. Supplier qualification records (including test data) for raw materials. 

II. Audit Procedures

1. In advance of facility visit, request and review the above-listed items. For each 

product, verify that the list of ingredients (including those from third-party suppliers) 

matches the formulation on record and formulation bills of material (e.g., batch 

tickets). Notify DfE of any discrepancies ASAP.

2. On-site:

a. Verify that labeled products are being manufactured with the ingredients agreed 

to under the partnership (and aligned with trade name/supplier), including at 

specified use levels, when appropriate;

b. Verify records for cleaning, maintenance, and calibration of manufacturing 

equipment (if not done before visit); 

c. Verify that any PL products packaged on-site are identical in formulation to the 

original recognized product (i.e., no dilution, concentration, no added dyes or 

fragrances);

d. Verify Good Manufacturing Practices (i.e., manufacturing and packaging 

operations conducted within the scope of an effective quality system (e.g. ISO 

9001) and in accordance with defined quality procedures (appropriate to the 

product type, e.g., cleaning). Include: 

• Production walk-through; 

• Review practices for minimizing contamination during measuring, blending, 

and packaging; and

• Verify bulk containers, transfer equipment, and holding vessels are in good 

repair.
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III.Audit Follow-up and Potential Noncompliance

1. Send written notice to the partner and DfE with a deadline for addressing the audit 

issues or correcting the noncompliance, as applicable. 

2. Verify corrective action and send an updated report to DfE (including the rootcause analysis, explanation of corrective action, and preventive action plan) 

within 30 days of notifying the client— OR— Notify DfE that the partner 

company has not addressed the audit issues or not corrected the noncompliance 

within the allotted time.

3. Submit an “On-site Audit Report” that summarizes all items that DfE should be 

aware of concerning the partner company’s audit, including all items that were 

acceptable and who performed the audit. Note: if there is a formula issue or a

problematic ingredient being used, please highlight this information in an email to 

DfE.