Quick Tips: One way to add flexibility to your QMS

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One problem many quality management systems have, is being too rigid.

Let’s take a look at an example…

Lena has started building a new product and has enlisted the help of a new contract manufacturer.

The part that the contract manufacturer will be building is a low-risk part that is very cheap to make.

According to their standard operating procedures, she cannot use them until an on-site audit has been conducted.

Lena checks and an on-site audit is not possible for the next two months.

Now Lena has a delay of two months.

So how could a better system be implemented?

The best starting point to remember is that supplier controls are supposed to help ensure quality of the final device before it is put into use. Bearing that in mind, here are some possible ways the process could be made more flexible, while still ensuring quality.

1. Lena’s organization could classify the products or services that suppliers provide by quality risk. Suppliers that provide low-risk components might not require an on-site audit, perhaps some sort of scoring system on their capability to provide quality components (such as if they adhere to ISO 13485).
2. Or, Lena’s organization could allow the purchase of low-cost products or services before the on-site audit as long as these components or their assemblies are quarantined until this takes place. The risk is that a supplier is not able to pass the audit and then these parts must be disposed of.
3. Finally, Lena’s organization could instead provide a procedure for deviating from a standard operating procedure including a plan, impact, mitigation, and approval.

A quality management system is there to help you achieve quality, but it does not have to be at the expense of productivity. If a procedure keeps ‘getting in the way’ maybe it is time to see whether another approach would be more efficient.