**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 Proc **ess** (based on 4/2011 Edition of the DfE S tandard) **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. P roduct labels showing use of the DfE logo or mention of DfE recognition; d. P roduct or compan y lit erature that uses the DfE logo or mention s DfE recognition; e. P rivate 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 b y the Partnership Agreement; and g. Documentation of education offered to end user s of Industrial/Institutional (I/I) products . **II. Audit**  **Procedure s**  1. Request above - listed materials.**OMB Control No. 2070 -**  **0178 Approval expires XX/XX/XX** 
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 compan y website. 4. Request updated PLforms to determine if PL product s should be added / removed from list of labeled products . Verify correct use of the DfE logo / program name on PLlabels, PL literature, and PLcompan y 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 an y unaddressed ingredient s . 6. Verify

that educat ion is being offered to the end user of I/I products as described in Section 3.4 of the S tandard . **III. Audit Follow**  **- up and P**  **o tential N**  **oncompliance** 1. Send written notice to the partner and DfE with a deadline for addressing the audit issues or correcting the nonc ompliance, as applicable. 2. Verify corrective action and send an updated report to DfE (including the root - cause anal ys is, explanation of corrective action, and preventive action plan) within 30 day s of notifying the client

– OR -- Notify DfE that the partner compan y has not addressed the audit issues or not correct ed the noncompliance within the allo tted 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)**OMB Control No. 2070 -**  **0178 Approval expires XX/XX/XX** 
**I. Materials Required in Advance**  **of Audit** a. Production records, batch tickets, bills of lading, certificates of analy sis, and any other formulation documentation; b. Customer and/or employee complaint file for any potentia l 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**  **Procedure s**  1. In advance of facility

visit, r equest 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 app ropriate ; b. Verify

r ecords for cleaning, maintenance, and calibration of manufacturing equipment (if not done before visit) ; c. Verify

that an y 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 s ys tem (e.g. ISO 9001) and in accordance with defined quality procedures ( app ropriate to the product ty

pe, 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 rep air .**OMB Control No. 2070 -**  **0178 Approval expires XX/XX/XX** 

**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 anal ys is, explanation of corrective action, and preventive action plan) within 30 day s of notifying the client

— OR

— Notify DfE that the partner compan y has not addressed the audit issues or not correct ed 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 compan y ’s audit , including all items that were acceptable and who performed the audit. Note: if there is a formula issue or a prob lematic ingredient being used , please highlight this in formation in an email to DfE.