Documentation structure - Do I need Work Instructions?

James

Involved In Discussions
#1
Hi all

Just wondered if anyone thinks this approach will be an issue? The system sits in a wider corporate and divisional structure.

I'm also thinking that instead of work instructions, I'll specify Device quality indicators instead? - appropriate?

system docs.JPG
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
This is the traditional documentation pyramid, and if it works for you, it's fine. I don't know what the bit to the right means, though, nor do I understand the idea of "device quality indicators" as opposed to work instructions.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3

Randy

Super Moderator
#4
In the end it doesn't really matter what you call anything or how you make it all happen as long as people that need to know, know, and you manage the process. I'm one of those "3rd party guys" and I honestly don't care what your structure looks like as long as it can be explained and proven to work as designed/defined, so go for it.
 

James

Involved In Discussions
#5
Great, thanks for the comments. I figured that naming conventions were just semantic. I don't want to use the term 'work instruction' as it implies detailed steps. Instead, I want to have much looser quality indicators; eg, you know how to build this product because you are a qualified technician and have seen the device technical documentation / image archive, but this is what 'quality' looks like for this device family, and we'll measure quality against these.

Quality System docs sit underneath corporate policy and alongside uncontrolled documents for each department; but if and when work activities hit the QMS scope, work is controlled and directed by the system. Only a very small amount of what we do hits the scope, so the system is nestled amongst much wider / informal systems.

Clear as mud! The Quality manual should clarify things I hope

Thanks again

James
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Quality System docs sit underneath corporate policy and alongside uncontrolled documents for each department; but if and when work activities hit the QMS scope, work is controlled and directed by the system. Only a very small amount of what we do hits the scope, so the system is nestled amongst much wider / informal systems.
Be VERY careful. One of the most typical and "deadly" mistakes when developing quality systems is to think that quality (and the quality system) lives/exists outside of the organization business processes. That is the surest way to sabotage your quality system maturity journey. Organizations who don't understand that are ALWAYS fighting a corporate dysfunction towards quality excellence. Until people understand that sustainable quality can only exist when it is seamlessly and stealthly embedded in the way business happens, it will be a Sisyphusian uphill battle.

If you REALLY want to delve into this, you could find direction from ISO/TR 10013:2001 - Guidelines for quality management system documentation, a document that is being revised and will become ISO/DIS 10013 Quality management systems — Guidance for documented information.

But the key thing to remember is that documentation (IN ANY FORM/MEDIA) serves the purpose of controlling processes and activities and have to fit the context of the organization and it's inherent risks. The pyramid approach is very archaic.

Good luck.
 

James

Involved In Discussions
#7
One of the most typical and "deadly" mistakes when developing quality systems is to think that quality (and the quality system) lives/exists outside of the organization business processes. That is the surest way to sabotage your quality system maturity journey. Organizations who don't understand that are ALWAYS fighting a corporate dysfunction towards quality excellence. Until people understand that sustainable quality can only exist when it is seamlessly and stealthly embedded in the way business happens, it will be a Sisyphusian uphill battle.
The reason for designing our approach in the way I've described is essentially to make it work and be a meaningful quality management system. We are a huge organisation; making medical devices is a tiny bit of the work that we do, but when we do it, we want to do it to a high standard and provide assurance to our customers that this is the case. We cannot expect or demand that the organisation flexes around our QMS policy and documentation requirements in that regard; it just needs to be concordant with it. Quite frankly, making medical devices does sit outside of many of our other organisational policies and procedures, but where this activity needs to, it will interface with relevant business processes. I understand the sentiment of your point, but National Health Systems are complex beasts. I'm describing a system that sits within and alongside other systems.
 

John Broomfield

Staff member
Super Moderator
#8
Indeed.

Quality services and products are delivered by management of the organization as a system that is the business management system.

Best for the QMS to integrate with and leverage this system instead of it being seen as separate.
 

Jim Wynne

Staff member
Admin
#9
The reason for designing our approach in the way I've described is essentially to make it work and be a meaningful quality management system. We are a huge organisation; making medical devices is a tiny bit of the work that we do, but when we do it, we want to do it to a high standard and provide assurance to our customers that this is the case. We cannot expect or demand that the organisation flexes around our QMS policy and documentation requirements in that regard; it just needs to be concordant with it. Quite frankly, making medical devices does sit outside of many of our other organisational policies and procedures, but where this activity needs to, it will interface with relevant business processes. I understand the sentiment of your point, but National Health Systems are complex beasts. I'm describing a system that sits within and alongside other systems.
While I tend to agree with Sidney when it comes to the archaic nature of the pyramid, I still say that if it works, it's OK. We're not in a position to see what you see. I will say, however that with regard to "quality indicators," it's almost always a mistake to believe that if you change the name of a thing, the nature of it will change. They're still instructions.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#10
The pyramid approach is very archaic.
As a typical hierarchy representation, it is quite common and easy for people to understand, in my opinion. That the pyramid representation is old isn't significant. In most companies a person can walk in and will find that the company's documentation is well represented by the pyramid.

But please - Seriously - Do explain how it is 'archaic' and it's negative aspects. And, what is a better way to show in a simple graphic the relationship of documents in a company.
 
Thread starter Similar threads Forum Replies Date
T Information and Structure for Technical Documentation for Firmware ISO 13485:2016 - Medical Device Quality Management Systems 1
AmandaMusser Documentation Confusion - Agile BOM Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Quality Manual shall Outline Structure of Documentation - Clause 4.2.2 ISO 13485:2016 - Medical Device Quality Management Systems 10
Q ISO 13485 Clause 4.2.2 Documentation Structure - Quality Manual clarification ISO 13485:2016 - Medical Device Quality Management Systems 6
C Structure and Content of DMR / Technical Documentation (FDA vs. ISO 13485)? Document Control Systems, Procedures, Forms and Templates 6
GStough Outline of the Structure of Documentation in Quality Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
U AS9100 Documentation structure and details - Seeking Advice Document Control Systems, Procedures, Forms and Templates 3
P ISO/TS 16949:2002 Documentation Structure IATF 16949 - Automotive Quality Systems Standard 6
G Structure in ISO 9001 documentation - Level 1, Level 2, Level 3, Level4, etc. Document Control Systems, Procedures, Forms and Templates 7
B Documentation Structure - What Do You Think? Document Control Systems, Procedures, Forms and Templates 17
I IATF Lab Scope Testing Qualification and Competency Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Documentation hold during submissions? ISO 13485:2016 - Medical Device Quality Management Systems 0
K SOUP (Software of Unknown Provenance) Anomaly Documentation IEC 62304 - Medical Device Software Life Cycle Processes 2
C Gobys for operations documentation plan Oil and Gas Industry Standards and Regulations 4
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Robert Stanley Required Documentation Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M What is the average time needed for process documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
was named killer CLOUD BASED QUALITY DOCUMENTATION vs. SERVER BASED Document Control Systems, Procedures, Forms and Templates 5
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
K ITAR Visitor Documentation of Citizenship AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
A Process Documentation for ISO 9001:2015 Internal Auditing 2
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Good Documentation Practices Self Test? ISO 13485:2016 - Medical Device Quality Management Systems 6
F ISO 17025:2017 mandatory documentation requirements ISO 17025 related Discussions 1
D Virtual Documentation via Master Flow Chart? Process Maps, Process Mapping and Turtle Diagrams 4
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
F PPAP Documentation Control APQP and PPAP 8
V Every good documentation practice observation is an data integrity issue US Food and Drug Administration (FDA) 7
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
DuncanGibbons Documentation aerospace OEMs require with purchase of parts from manufacturers/suppliers Manufacturing and Related Processes 0
V What is the criteria to cite an good documentation practices observation as an data integrity related issue US Food and Drug Administration (FDA) 6
L AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
L ISO 9001:2015 standard documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
W Documentation - Use of Addendum vs Amendment Document Control Systems, Procedures, Forms and Templates 1
I What level of change in documentation requires re-training? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
D QMS Documentation Process - I want to put all the Process SOPs to a QMS system Document Control Systems, Procedures, Forms and Templates 3
T QMS - Documentation Cloud Storage EU Medical Device Regulations 0
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22

Similar threads

Top Bottom