During my career in manufacturing, I've had the good fortune to work for both OEMs (original equipment manufacturers) and contract manufacturers that make things for others. One of the things I've had to deal with in both business models was ensuring products met the expectations of the end user or customer. One of our key concerns was the safety of the product, and we did a few things to ensure the product was delivered safely to the customer.
The first step is having a product design and safety team. The role of the product design team is to review each step during the design process. The product safety team’s responsibility is to ensure the product is as safe as it can be. Both teams should be made up of a cross-section of technical staff, engineering, manufacturing, marketing, and sales. Team members should have authority to intervene when needed and should be reporting to a C-level executive or equivalent. Some team members can be on both teams. However, additional non-technical team members should be added.
The product review team’s role is to review the design for:
Manufacturability
Product reliability
Where and how is the product used?
Is the product designed to industry standards such as ANSI, ISO, SAE, AS9100?
Establish a product testing procedure
Perform an FMEA (failure mode and effect analysis)
Material/component review
Ensure suppliers understand parts/material usage
End user, operator concerns
Ensure that end users understand product intention
Good owner’s manual
Field install/maintenance
Ease of maintenance and serviceability
The product safety team’s role is to ensure the product is as safe as it can be.
Assure compliance with legal and regulatory requirements
Identify any potential hazards
What can go wrong with the product?
Identify and notify the design team of potential hazards
Provide solutions
Identify needed warnings
Ensure manual and labels are compliant with ANSI standard Z535.4
Identify labels and label placement
Identify potential safeguards
Covers, guards, dead man's switches, etc.
Identify potential misuse of product
Develop safety warnings against misuse
Identify potential design changes to prevent misuse
Develop potential safeguards against misuses
Before the product is released to manufacturing, additional steps should be taken:
Develop sound manufacturing processes
Understand product use and intention
Use industry standards and best practices to manufacture the product
Establish manufacturing specifications
Establish quality control processes
Use SPC (statistical process control)
Establish check frequency
Inspection sheets
Measurement methods, etc.
Ensure incoming components meet product specifications
Perform an FMEA for the process
Develop an ongoing product testing process
Establish audit procedures
The steps above are especially critical if you are a contract manufacturer, as you most likely were not involved in the design phase.
During manufacturing
Ensure compliance with:
Quality control procedures and processes
Document all deviations
Update manufacturing processes as needed
Ensure problems are addressed and resolved in a timely manner
Document:
What caused the issues?
What was done to resolve the issues?
If you are a contract manufacturer, communicate issues and changes with the OEM and document those communications
Establish a closed loop system that communicates any product failure or issues with engineering, manufacturing, and design
Field service and install
Customer service
Warranty claims
Distributors
If you have been in manufacturing for as long as I have, you most likely know that even when everything is done right, things can go wrong. Here are additional things you should have in place in case something with your product goes wrong.
A crisis communication plan:
Who are the key contact points within your organization?
How do you notify your customers?
How do you communicate issues?
How is the media managed and by whom?
Establish a product recall plan and process
Obtain product liability insurance (PLI)
Even if you are not an OEM, but a contract part manufacturer for others, you are not in the clear. Many purchase agreements hold the manufacturer of the actual part responsible if something goes wrong. Take the time and read your purchase orders and agreements. You may want to have legal counsel review them too. If they do not have a hold harmless clause in them, you can be held accountable and your business might be at risk. You can counter this by sending your own purchase agreement with a hold harmless clause to your customer.
Most likely you have manufactured many parts and nothing has gone wrong. This can be due to good luck or it can be because you have sound manufacturing principles in place and follow the outlined steps above.
An insurance company that cares about you and insuring the things you wish to be insured.
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