Establishing a Proper Compliance Program

Is my safety program where it needs to be?

This is a common question that a company must ask itself in regards to their safety program. Unfortunately there is not a guideline out there that is going to give you step-by-step guidance as to how to put one together. Every program built is unique to the company and the types of products they are manufacturing and/or importing. 

What a company can do to insure they are on the right track is ask themselves the right questions.  

The following 9 Questions can help you gauge if your "Compliance Program" is where it needs to be.

• Do you have a formal Statement of Management Policy?
• Does your team have knowledge of specific requirements that pertain to your product and the countries they will be sold in?
• Have internal manuals, documents, and procedures necessary for compliance been created and kept?
• What are your record keeping procedures?
• Do you have complete ownership of compliance for your vendors and/or manufactures?
•  Have you or your team had regulatory training and been certified?
• Have you formalized internal Audits and SOPs?
• How many times a year do you perform internal mock recalls, product defect situations, and contamination procedure exercises?
• Do you have a cross department safety council?

It is imperative that vendors and manufactures of consumer goods consistently evaluate the state of their program and make necessary adjustments as needed.

Have a question? Feel free to send it to QualityAssurace@CPTSol.com

CPTS Team

Lead, Phthalates, and Inaccessible Parts

Knowing what needs to be tested and more importantly what doesn't, is a common theme we see with inexperienced manufactures, importers and retailers. 

Did you know that parts that are not easy accessible through normal use, do not need to be tested for Lead or Phthalates? 

According to the CPSC, ''lead and phthalate limits shall not apply to any component part of a children’s product that is not accessible to a child through normal and reasonably foreseeable use and abuse."

One of the most common places where testing costs can be reduced is by understanding the differences between these accessible parts and inaccessible parts.

So how do we determine if a part is inaccessible? According to the CPSC a component part is not accessible if it is:

• Not physically exposed by reason of a sealed covering or casing 
• Does not become physically exposed through reasonably foreseeable use
• Abuse of the product including swallowing, mouthing, breaking, or other children’s activities, and the aging of the product, does not case the part to become accessible 
• Parts do not become explodes after the CPSIA Physical/Mechanical test.

Please note that paint, coatings, fabric, or electroplating may not be considered to be a barrier that would render a part to be inaccessible.

We often see a business submit a product or a component to a laboratory for testing without stating certain areas of inaccessibility. The lab will then either A) assume the parts are accessible or B) flat out charge the extra testing cost if the business did not ask for the exemption. 

In short, take the time to determine parts that are inaccessible in your product and more importantly make sure to review with the lab any reasons why inaccessible parts were wrongfully tested.

As always,  please feel free to send your comments/questions to QualityAssurance@cptsol.com

CPTS

Dissecting the Test: Lead in Surface Coating Part 1

In this week’s edition of Dissecting the Test, we turn our focus to one of the leading tests in the consumer products industry.

Lead, a chemical element in the carbon group (also known as Pb) was once used for products such as, paints, bullets, and pipes. Once the realization of the dangers that lead has on adults and children’s became more publicly aware, lead limits were put into place to combat the medical issues.

The Danger

Lead is a highly poisonous metal if inhaled or swallowed, affecting almost every organ and system in the body, especially the nervous system.

Invisible to the naked eye and having no distinctive smell, adults and children may be exposed to it from consumer products even through normal handling of products.

If ingested, lead is poisonous to humans. Like the element mercury, another heavy metal, lead is a neurotoxin that accumulates both in soft tissues and in the bones.

The Reason

The driving factor for lead still being found in consumer products is cost. Lead paints are cheaper than most alternatives, which gives way to the manufactures whom cut corners and use the cheaper leaded paint. Not helping matters is the "consumer products" market being intensely competitive as well as a poorly regulated market in most foreign countries.

The Regulation

If your product falls under the lead regulation requirement, you must insure that it does not contain levels of lead in excess of the 0.009 percent limit (90 parts per million).

The Method

Part One: Digestion of Samples

Step one in the process is removing the painted surface coating from the sample. This is typically performed by using a razor blade to carefully scrape the surface coating paint, while making sure to remove as little of the substrate (or base material) as possible from the sample.

Once 30-100mg of coating is removed, it is placed in a digestion tube, where nitric acid is added. After cooling, a second acid, hydrochloric is added along with distilled water. The tube is then lightly shaken and/or stirred (insert bad James Bond joke of your choosing).  

Part Two: Total Lead in Metals Analysis

Step two in the process is taking the tube sample with it’s contents and placing them into a machine called an ICP spectrometer. With additional science that I won’t bore you with, the contents are calculated, accounting for all dilution and is reported as a percent by weight.

Tada……….Your lead test is complete!

Next Monday we will continue with Dissecting the Test: Lead in Surface Coating Part 2