Quality Assurance Procedures vs. Standard Operating Procedures

  • Thread starter Rajesh Anantharaman
  • Start date
R

Rajesh Anantharaman

#1
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:confused:

Your comments and inputs

Thanks:thanx:
 
Elsmar Forum Sponsor
F

fuzzy

#2
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:thanx:
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.:2cents: Hope you find this helpful.
 
R

Rajesh Anantharaman

#3
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.:2cents: 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

Quite Involved in Discussions
#4
Welcome to the Cove!:bigwave:
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.
 
P

potdar

#5
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.:nope:
 
R

Rajesh Anantharaman

#6
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
 
L

Linda W

#7
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
 
F

fuzzy

#8
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:thanx: , 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:D . 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.:applause:
 
R

Rajesh Anantharaman

#9
Thanks everyone for your valuable suggestions and tips. and please add more to this thread if you have anything else to share.

I will be firing a lot more questions in the coming days and hope all the Quality Gurus can bail me out (again)

Best Regards

Rajesh
 

Randy

Super Moderator
#10
Do whatever you want;

Call things whatever you want;

It doesn't really matter what you call them or what you do with them as long as you meet the requirements of 4.2.3 and 4.2.4.


Worry and fret over the really important stuff like actually doing it.

Everything else is dribble.
 
Thread starter Similar threads Forum Replies Date
M The System engineering procedures is it considerd as Quality Assurance Procedurcs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Quality Assurance procedures for EMC (Electromagnetic Compatibility) Compliance CE Marking (Conformité Européene) / CB Scheme 4
K Supplier Quality Assurance Procedures & QS 9000 Supplier Quality Assurance and other Supplier Issues 8
Marc Job Opportunity – Quality Assurance Specialist - Suspense 7 April 2021 Job Openings, Consulting and Employment Opportunities 0
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
C Quality assurance in Pharmacovigilance Document Control Systems, Procedures, Forms and Templates 2
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Quality Assurance in China - Developing a quality management system for a California company Misc. Quality Assurance and Business Systems Related Topics 9
C Independence of DQA (Design Quality Assurance) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Pancho Definition Quality Assurance Program - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
chris1price MDR Conformity Assessment for a Class 2a device - Production Quality Assurance EU Medical Device Regulations 2
L Definition Mini Builds - Quality Assurance Terms and Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
Marc Adventures in Design Quality Assurance - Two-week-old Pixel 2 XL displays World News 0
P Quality Assurance and Quality Control - Which clauses of ISO 9001 deal with each? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A KPI for Quality Assurance Team in a Service Oriented Industry Service Industry Specific Topics 8
C I'm starting my Career in Quality Assurance Career and Occupation Discussions 8
E Employees in Quality Assurance Jobs Career and Occupation Discussions 2
Y Outsourced aerospace work quality assurance? Supplier Quality Assurance and other Supplier Issues 6
R Quality Assurance Assessment of the F-35 Lightning II Program AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Quality Assurance in an Architectural firm Misc. Quality Assurance and Business Systems Related Topics 3
M QAM (Quality Assurance Matrix) for a sterilization process Quality Tools, Improvement and Analysis 1
S Quality Assurance Plan template for CNC Milling Industry AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A Career Path Options for Quality Assurance Engineer in Roads & Infrastructure Field Career and Occupation Discussions 2
C Quality Assurance Manager ? Next Steps? Quality Manager and Management Related Issues 10
S Quality Assurance Manager involvement in Management Review AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
R Quality Assurance/Quality Control in Education Consultacy Service Industry Specific Topics 14
E Use of Certified Reference Materials for Quality Assurance General Measurement Device and Calibration Topics 6
Q Quality Objectives for Quality Control and Quality Assurance functions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Using Exact Words from ISO 9001:2008 in Level 1 Document (Quality Assurance Manual) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
S Implementing a Quality Assurance Program Service Industry Specific Topics 3
J Appliance Manufacturing - Quality Assurance Mentor Wanted Career and Occupation Discussions 13
A Incoming Material Quality Assurance Cell Document Control Systems, Procedures, Forms and Templates 4
M Bachelor Degrees in Quality Management or Quality Assurance Career and Occupation Discussions 3
M How to be a good Quality Assurance Engineer Career and Occupation Discussions 6
M Designing a Quality Assurance and Control System Quality Manager and Management Related Issues 3
J Resistance to Change as a Master Thesis in Quality Assurance Professional Certifications and Degrees 7
P Definition Quality Control vs Quality Assurance - Differences or Semantics Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 26
A Quality Assurance Stamps and Supplies for Certifying Product Misc. Quality Assurance and Business Systems Related Topics 2
E Full Quality Assurance Certificate EU Medical Device Regulations 5
P Why does a SQA (Software Quality Assurance) standard be implemented in our company Software Quality Assurance 4
M QA (Quality Assurance) Monthly Report for Repaired Pallets Document Control Systems, Procedures, Forms and Templates 2
Z Quality Assurance Plan for Engineering Service Industry Quality Manager and Management Related Issues 1
P Level 5 CQI Diploma in Quality (Assurance and Management) Covegratulations 7
M New appointment as Quality Assurance Executive - Job Scope Career and Occupation Discussions 3
I Quality Assurance Business Plan & Strategy Quality Tools, Improvement and Analysis 3
E Responsibilities of a QA (Quality Assurance) Inspector Career and Occupation Discussions 5
P What is the last revision of Toyota SQAM (Supplier Quality Assurance Manual)? Customer and Company Specific Requirements 3
A Suggest Computer Aided Quality Assurance (CAQ) software for Medical Devices Quality Assurance and Compliance Software Tools and Solutions 3
N Customer Service/Inside Sales Will Not Leave Us (Quality Assurance) Alone! Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom