Quality Assurance Procedures vs. Standard Operating Procedures

[Rajesh Anantharaman]

Hello Members,

I am new to the Cove and also to a start-up medical device company. I am trying to implement a Quality System based on ISO 13485.

I have proposed a 3 tier quality system for our company
Tier 1 -- Quality Manual
Tier 2 -- Quality Assurance Procedures (QAP)
Tier 3 -- Standard Operating Procedures (SOP) & Forms

The QAPs include procedures for purchasing, customer complaints, reworks, inspections and testing etc..(you get the idea) and the SOPs include procedures for passivating, anodizing, laser etching, calibrations etc..

I wanted to know is it conflicting that both the QAPs and SOPs are telling me WHAT and HOW to do things. Is it ok to follow this way or is it better to plug all HOW and WHAT things together in a SOPs. I am a bit confused

Your comments and inputs

Thanks

[fuzzy]

In Reply to Parent Post by Rajesh Anantharaman

Hello Members,

I am new to the Cove and also to a start-up medical device company. I am trying to implement a Quality System based on ISO 13485.

I have proposed a 3 tier quality system for our company
Tier 1 -- Quality Manual
Tier 2 -- Quality Assurance Procedures (QAP)
Tier 3 -- Standard Operating Procedures (SOP) & Forms


...Thanks

Welcome to the Cove, Rajesh. I think the general structure for most documentation systems are similar to yours. The distinction I make between Level 2 (or Tier, as you said) vs. Level 3 (often called Work Instructions or WI's) is the level of detail involved, and how narrowly focused that detail is. For example, I can have a Level 2 document that describes the Corrective action process and how it functions for all areas of the company, but my Level 3 document may describe exactly how a CA request is processed, how the form is filled out, who takes care of and where the CA records are located, etc., etc. So in my mind Level 2 (often called Procedures) are more general overviews of a process / task / requirement, while the WI level is much more detailed, user-orientated types of documents. Hope you find this helpful.

[Rajesh Anantharaman]

In Reply to Parent Post by fuzzy

Welcome to the Cove, Rajesh. I think the general structure for most documentation systems are similar to yours. The distinction I make between Level 2 (or Tier, as you said) vs. Level 3 (often called Work Instructions or WI's) is the level of detail involved, and how narrowly focused that detail is. For example, I can have a Level 2 document that describes the Corrective action process and how it functions for all areas of the company, but my Level 3 document may describe exactly how a CA request is processed, how the form is filled out, who takes care of and where the CA records are located, etc., etc. So in my mind Level 2 (often called Procedures) are more general overviews of a process / task / requirement, while the WI level is much more detailed, user-orientated types of documents. Hope you find this helpful.

Hello Fuzzy,

Is it possible in this case to make the Level 2 procedure detail oriented so as to avoid creating a WI for the corrective action process. I am asking this because, in the Quality Manual (Level 1), there is no need to reference both the SOP and the QAP for a particular process (in this case Corrective action)??

Rajesh

[Wes Bucey]

Welcome to the Cove!
I recently consulted for an Illinois medical device manufacturer now approved for ISO 13485 and also now has its CE mark. There aren't many "trick requirements" - the primary thing to consider is whether you have straightforward documentation of your processes (the plan and the record of actually following the plan) and proper validation of the processes which ought to be validated.

It is not a simple process, but it can be done if you and top management are in sync. If you really get hung up on the part of everyone working together (you will have a rough row to hoe if the bosses expect you to do this in a vacuum), don't hesitate to arrange a phone conference with me to help you over the rough patches.

The Quality Manual should mirror what the company actually intends to do, not what they think should be in the manual.

[potdar]

In Reply to Parent Post by Rajesh Anantharaman

Hello Fuzzy,

Is it possible in this case to make the Level 2 procedure detail oriented so as to avoid creating a WI for the corrective action process. I am asking this because, in the Quality Manual (Level 1), there is no need to reference both the SOP and the QAP for a particular process (in this case Corrective action)??

Rajesh

Perfectly OK.

I may add that the QMS is a dynamic document. it changes as the company, its processes, its products change. Its much simpler from a futuristic view to separate the portions likely to change frequently into tier 2 / Tier 3 documents while the generalised instructions / policies that dont change every day stay in the higher level documents. You are the best judge for what stays where for your company.

And yes, frame your documentation based on your current practices + anything that the standard may want you to add / tweak. Dont import a set of documents and try to change your working style accordingly, or worse still, dont get into the trap of generating two sets of records - one for the management who want to see the day to day performance of the company and one for your registrar who wants to see compliance with your QMS.

[Rajesh Anantharaman]

Hello Mr Bucey and Mr Potdar,

My company is very small and management is not looking to expand very fast either. So I was thinking, I will add the procedures to the QAP's for now and the SOP's can include the manufacturing processes (like passivation, anodizing etc.)

I look forward to talking with you soon Mr Bucey.

Thanks

Rajesh

[Linda W]

Rajesh,

The thing that is most important is to have meaningful documents that clearly let the employees know what they must be doing. Some of the documents will be addressing ISO and QSR regulations and some will be how to perform their job to get the process completed the same way each time.

So however you want to set up the system - as long as you accomplish those 2 things- you are doing the right thing!!!!

I've worked for a number of companies - doing different approaches - what works for one company won't necessarily for another. I always tell my people to meet the "intent" of the standard/regulation - there is always room to maneuver!

Linda

[fuzzy]

In Reply to Parent Post by Rajesh Anantharaman

Hello Fuzzy,

Is it possible in this case to make the Level 2 procedure detail oriented so as to avoid creating a WI for the corrective action process. I am asking this because, in the Quality Manual (Level 1), there is no need to reference both the SOP and the QAP for a particular process (in this case Corrective action)??

Rajesh

As potdar replied , yes it's perfectly OK. I have done some similar things in my system. In some cases the standard requirements are covered by statements only in the QMS Manual: there are no Level 2 or 3 documents . So you can tailor your document system to match the simplicity or complexity of your business. That's the beauty of ISO 9001:2000 based systems.