Deviations - Where in ISO 13485 deviations are covered?

[duff999]

While creating a deviation SOP, I'm trying to find what ISO13485:2016 standard fits best for deviations as a reference.

Thanks

 

[Tagin]

I would think 7.3.9 Control of design and development changes. But of course, depending on the change, impact may occur in additional clauses.

 

[shimonv]

From my experience, deviations are more commonly used in production. I would recommend referencing:
7.5.1 Control of production and service provision

In fact, ISO TC 210 mentions deviations in the context of section 7.5.1:
"During manufacture, relevant information should be entered onto the batch record. Such information can include the:

• quantity of raw materials, components and intermediate product, and their
  batch number, if appropriate,
• production records including operating parameters,
• date of start and completion of different stages of production, including
  sterilization records if appropriate,
• quantity of product manufactured,
• signed results of all inspections and tests,
• designation of the product line used,
• product or process nonconformances including any correction, and
• deviation from the manufacturing specifications. "

Shimon

 

[Sidney Vianna]

If we understand deviation as departure from the originally specified requirements, last paragraph of 8.3.2 is paramount. 8.3.3 as well.

 

[duff999]

Thanks for the replies folks. It seems deviations can touch many aspects of ISO 13485, depending on what the situation is.

 

[Jim Wynne]

We don't know what "deviation" means in this context. Are we talking about any excursion outside of tolerance limits? Are we talking about what ISO normally refers to as "concession," where a customer is asked to conditionally accept nonconforming product? In the latter case, the word "waiver" is also used sometimes.

More information is needed. What is the proposed procedure intended to address?

 

[moritz]

In the companies I have worked for, deviations from planned processes (e.g. departure from an SOP) were always treated like nonconforming product, i.e., chapter 8.3 would describe how to handle them. Each department could see their downstream departments as customers and the output of their processes as their products. If the product does not conform to its specifications (in this case, the planned procedure), it is an NC. I think that does make sense, too, because you might want to correct the deviation anyways and evaluate its impact on your downstream processes. A documented NC event is a great vehicle to document both activities.

 

[Jim Wynne]

In the companies I have worked for, deviations from planned processes (e.g. departure from an SOP) were always treated like nonconforming product, i.e., chapter 8.3 would describe how to handle them. Each department could see their downstream departments as customers and the output of their processes as their products. If the product does not conform to its specifications (in this case, the planned procedure), it is an NC. I think that does make sense, too, because you might want to correct the deviation anyways and evaluate its impact on your downstream processes. A documented NC event is a great vehicle to document both activities.

If this approach works for you, that's fine, but once again we need to differentiate between deviations and waivers. In most cases, these things apply to products and not processes, necessarily. When you do characterize "deviation" as temporarily changing a process, and your system describes the circumstances and requirements for doing so, you don't have a nonconforming condition (failure to meet a requirement) because the requirements have been changed, albeit temporarily.