@Risk

The Procter & Gamble Company and the U.S. Environmental Protection Agency (EPA) National Risk Management Research Laboratory (NRMRL) have announced the signing of a Cooperative Research and Development Agreement (CRADA) to develop new tools to optimize sustainability improvements in manufacturing facilities, and their associated supply chains.

These improvements will directly address the endpoints of P&G’s long-term environmental sustainability vision, announced in September of 2010. This vision includes: 1) Powering its plants with 100% renewable energy; 2) Using 100% renewable materials or recyclate for all its products and packaging; 3) Having zero consumer or manufacturing waste going to landfills; and 4) Designing products that delight consumers while maximizing the conservation of resources.

In order to meet this commitment, new methods and tools are needed to help optimize design and decision-making across a wide range of operations and supply choices, as well as various environmental sustainability measures. The EPA has developed a comprehensive list of sustainability metrics and performance indicators that can be used to quantify sustainability in a manufacturing and supply chain context, while P&G has a diverse set of manufacturing operations and supply chains that can be leveraged to optimize how such metrics are used to guide improvement choices. The work under this CRADA will leverage P&G’s manufacturing and supply chain knowledge with the EPA’s work on metrics to develop a modeling and assessment tool that can be used to assess future product design, material sourcing, and manufacturing options.

Do these questions sound familiar?

• “We deal with a lot of companies with satellite plants. Should we have one global quality agreement with the headquarters or one for each facility?”

• “Our quality requirements are stated on the back of the purchase orders as standard boilerplate. Is that an adequate quality agreement?”

• “I’m being told to accept materials that were shipped prior to a quality agreement being in place? Is this OK?”

• “MHRA plans to inspect one of our API suppliers. In addition to the quality system, they also want to review product specific compliance? How should we prepare for that?”

• “My suppliers are small. How can I expect them to meet quality requirements?”

One place we’ve found to learn how others deal with these issues is at: The Supplier Quality Management Congress. July 31 – Aug. 2, 2012, in Bethesda, MD.

It’s a day and a half of intensive learning, including:

• Update on supply chain regulation signed by President Obama
• Best practices for managing risk in the supply chain
• Import holds and the impact of the FDA’s PREDICT system
• Qualification techniques for international suppliers
• How to apply lean principles to supplier assessment criteria

This year’s speakers, include:

• Melissa Torres, Biomedical Engineer, Office of Compliance, CDRH, FDA
• Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding
• Sara Dyson, Assistant Vice President, Medmarc Insurance Group
• Jonathan Lee, President, Medical Device Consulting Solutions International
• Stephen Amato, Managing Director, tJun 17 Life Sciences

CONFERENCE DETAILS

Fourth Annual Supplier Quality Congress
Assuring the Integrity of Drug and Device Raw Materials and Supply Chains
**Presented by FDAnews**
July 31 – Aug. 2, 2012 – Bethesda, MD

We always enjoy events that provide insight on supplier quality and risk, so happy to pass this along.

Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Pub. L. 94-409, that the Securities and Exchange Commission will hold an Open Meeting on Wednesday, August 22, 2012 at 10:00 a.m., in the Auditorium, Room L-002.

The subject matters of the Open Meeting will be:

• Item 1: The Commission will consider whether to adopt rules regarding disclosure and reporting obligations with respect to the use of conflict minerals to implement the requirements of Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act.
• Item 2: The Commission will consider whether to adopt rules regarding disclosure and reporting obligations with respect to payments to governments made by resource extraction issuers to implement the requirements of Section 1504 of the Dodd-Frank Wall Street Reform and Consumer Protection Act.
• Item 3: The Commission will consider rules to eliminate the prohibition against general solicitation and general advertising in securities offerings conducted pursuant to Rule 506 of Regulation D under the Securities Act and Rule 144A under the Securities Act, as mandated by Section 201(a) of the Jumpstart Our Business Startups Act.

Let’s hope that this time we get some actionable information and guidelines. All of the practitioners I’ve spoken to are moving forward with some type of compliance and reporting plans based upon expectations, but having a firm target will simplify everyone’s life.