Who's responsible for faulty product?

Belinda Carli

Faulty product: a brand owners’ worst nightmare! When the batch hasn’t turned out as planned – or worse, needs to be recalled from the market - who is responsible? Is it the manufacturer, who made the product? Is it the formulator, who created the formula? Or did the brand owner launch the product into the market place without conducting appropriate tests?

More importantly: how do you make sure this doesn’t happen to you?

 

 

 

 What is the manufacturer responsible for?

Before I can answer this question, I need to ask you another: do you have a contract manufacturing agreement in place? This should clearly stipulate what the manufacturer is responsible for, and what the brand is responsible for. If you have one of these agreements in place, it should provide you with clear guidance on who is responsible for each step in the manufacturing process. If you don’t have one, get one! Here are some things you need to consider:

• Was appropriate scale up done from the lab samples to production? Making a sample in the lab is completely different to making 200kg or more of product – was product appropriately scaled up to check the method would suit the larger batch size? Lab and pilot batches cost more to produce per unit than the full batch – but skipping this step could leave the brand owner responsible for a failed batch!
• Were all materials used as specified in the formulation, from the same suppliers specified in the formulation? The same material from different suppliers can yield a different end product – the same suppliers should therefore be used or the manufacturer needs to conduct appropriate sample development to ensure a change in supplier will not affect the end product.
• Was the method appropriately followed? The method of manufacture is crucial to a formulas success, at lab sample, pilot and full production stages. During scale up it is also crucial that the manufacturer adapts the lab method to suit their specific machinery and the needs of the materials.

If there is likely to be an issue with the product, it is usually picked up during the scale up steps before a full batch is made, which is why scale up is so essential. Scale-up issues may be correctable, and in any case, save the cost of a failed full production batch. Don’t skip scale-up… ever!

What is the formulator responsible for?

Before I can answer this question, I need to ask you another: do you have a development agreement in place? This should clearly stipulate what the formulator is responsible for, and what the brand is responsible for. If you don’t have one, get one!

The formulator is contracted to create the product and formula in such a way and using sufficient detail to enable a manufacturer or other chemist to reproduce that product in lab size samples. They are generally responsible for ensuring theoretical safety, stability and performance attributes of a product; but the actual proof of this safety, stability and performance requires additional testing (e.g. PET, full accelerated stability and product evaluation tests) which is the brand owners responsibility. Before a brand owner signs off on a formula, they should be happy with its performance – then it can get sent for PET and full stability tests. What happens if the product fails PET and stability? The formulator can then correct these issues with further re-testing conducted (at the brand owners expense if suitable theory was used in the first place; or at the formulators expense if theory was not sound). If suitable testing is done at the formulation sign off stage, it could save potential issues before proceeding to pilot and full scale batches.

What is the brand owner responsible for?

Ultimately, the brand owner is responsible to ensure the product in the market place is safe when used. How do they do this? Appropriate development steps and testing should be conducted prior to manufacture; it is a brand owners responsibility to ensure appropriate testing is conducted to confirm the safety, suitability and shelf life of a product. Appropriate scale up steps should be followed to ensure the manufactured product is exactly as was tested/proven suitable during development; it is a brand owners responsibility to cover the additional costs involved with pilot production. Where the brand owner has a suitable budget for R&D, the costs of testing and pilot production should be adequately covered as part of any normal development process and should come as no surprise. This is all just part of properly conducted product development!

All too often we see brand owners skip crucial steps and when something goes wrong, try to point the blame (and costs of recall and reproduction) at the manufacturer or formulator – but skipping these crucial steps could leave the brand owner liable – a costly lesson to learn!

What should you do when something goes wrong?

Regardless of what has gone wrong, the answer to this question is always the same: INVESTIGATE. Proper scientific investigation needs to be conducted into what went wrong, who is at fault and most important, what can be done to either fix the current situation or fix it for future production. Investigation is crucial no matter what, and should be conducted in an appropriately scientific manner without hostilities or blame being cast prior to investigation results being obtained.

Want to make sure you get it right?

• Brand owners: learn who holds responsibility for what – we have Certificate courses and full Diplomas on brand management which specifically address and train on these requirements. Our training also provides Contract Manufacturing Agreements and Development Agreements so you can clarify responsibilities and prevent issues from the outset!
• Manufacturers: upskill your staff – from Production Assistant/Entry level through to full formulation and quality control. We also train on/can provide Contract Manufacturing Agreements you can tailor to your premises so anyone you manufacture for has a clear understanding of who is responsible for every stage of manufacture, from packaging and material sourcing through to quality checks.
• Formulators: ensure robust theory is built into your formulations and method. You may need to justify why you have selected certain ingredients and/or used a certain method - make sure you get it right! We have Certificate courses through to full Diplomas to help make sure you make the right selections as well as train on Development Agreements to clearly stipulate what you hold responsibility for.

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