Technical Documents Numbering System - Manuals, Procedures and Wi's

P

Paula JS

#41
Hi guys
I'd agree with a comment Jane made earlier - why do you need the numbering schema?

Let me give you the scenario:
- Working electronically
- Have both an organisation wide Document Mgmt System and a specific application for engineering projects and document control

Numbering requirement:
The only requirement I can find across all the reading I have done is that controlled documents need a unique identifier. Beyond that it is a business decision.

So given that both my systems can generate unique sequential ID's what are the benefits of having a complex numbering schema such as those many of you have suggested.

Especially given that I also have:
- Document Names
- Advanced Search capability
- Additional metadata tags to cross reference and identify content

Can someone please explain the business benefit of the complex numbering schemes?

Thanks!
 
Elsmar Forum Sponsor
S

SHall

#42
Using a system with categories as I described above for document identifiers allows easy cross referencing to other requirements:

  • Doc Control - Required approvals (by function /level)
  • Training requirements - whole categories will never require training
  • Document retention times - even electronically, you don't want to keep it all forever

The ability to communicate these ideas clearly across multiple procedures within the quality system is helpful. This could be accomplished with tags, however you'd still need the concept of categories to make it work, and it would be a bit abstract if not encoded in the number, and if it relies on humans to remember to apply the appropriate tag, there will be failures.

I'm on the fence about part numbers for actual things, but that's probably a discussion for a different message board entirely.

Shelley
 

rogerpenna

Involved In Discussions
#43
At my company, we divide documents by folder, and each folder is for a type of document (Quality Manual, Procedures, Work Instructions, Job Descriptions, External Documents, Records, Forms, etc).

Each type of document has a different acronym, which forms the 3 first letters of the numbering/coding system.

MGQ (Manual do Sistema de Gestão da Qualidade)
PQP (Procedimento da Qualidade PavCo)
ITP (Instrução de Trabalho PavCo)
DC (Descrição de Cargo)
DE (Documentos Externos)
etc. Above are in portuguese. But you get an idea.

They are all followed by the department they belong too. Some administrative documents are more general in this description.

PQP-SGQ (SGQ: Sistema Gestão Qualidade... QMS in portuguese). So a Quality Procedure.

PQP-ADM

PQP-MAN (Maintenance Department Procedure)
 
Thread starter Similar threads Forum Replies Date
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
K What technical documents need to be maintained for "manufactured for" items 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S RAPS Article on STED (Summary Technical Documents) Other Medical Device Regulations World-Wide 1
Q How to name ISO 9001 Checklist, Documents and/or Technical Documents? Document Control Systems, Procedures, Forms and Templates 2
W Does my Technical Library belong on my Documents List? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Technical Documentation Package (TDP) - Listing of the types of documents contained Document Control Systems, Procedures, Forms and Templates 4
K Technical file for mhra CE Marking (Conformité Européene) / CB Scheme 2
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
O Soft and technical skills for a VP of Quality Career and Occupation Discussions 1
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 4
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
R MDR & depth of technical files review by NB's EU Medical Device Regulations 18
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 3
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
G Same intended use devices - Technical file EU Medical Device Regulations 5
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
B Clause 5.1.12 of Technical Standard IEC 62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5
V Iso13485 certification vs CE technical audit ISO 13485:2016 - Medical Device Quality Management Systems 3
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 7
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
F Recommended practice for furnishing Technical Procedures ISO 17025 related Discussions 1
S How to find technical specification for facilities maintainance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Special Processes - Technical reason concerning torque - Anaerobic compounds Manufacturing and Related Processes 10
N Technical file requirements class 1 device MDR Other Medical Device Regulations World-Wide 6
T Change in BRH (Brazilian Registration Holder) Technical Manager Other Medical Device Regulations World-Wide 2
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
O Medical Device Technical File Confidentiality - On site reviews EU Medical Device Regulations 14
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
M Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Considerations for Non- Clinical Assessment of Medical Devices containing Nitinol Medical Device and FDA Regulations and Standards News 0
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
M Informational IMDRF final document – Assembly and Technical Guide for IMDRF Table of Contents Submissions Medical Device and FDA Regulations and Standards News 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
M Medical Devices and ASD-STE100 (Simplified Technical English) Other Medical Device Related Standards 0
B IATF 16949:2016 – Technical Specification (eBook edition) IATF 16949 - Automotive Quality Systems Standard 1
S MDR Technical File Structure Requirements EU Medical Device Regulations 12
L 510k exemption process - Do you still need to submit technical dossier? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D MDD to MDR - Technical File conversion EU Medical Device Regulations 4
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2

Similar threads

Top Bottom