Size of QMS - QMS system that has over 6,200 files spread across 685 folders

Proud Liberal

Quite Involved in Discussions
#1
Looking for opinions / comments from an auditor's and user's viewpoint on a QMS system that has over 6,200 files spread across 685 folders.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
What type of files? What software for control, or do people just traverse directories to get to the one they want/need to access? Is there some type of "sitemap" that employees can use to find specific directories and/or files? Is there a document database of any kind?

The size of the QMS depends upon the size of the company, including how many documents there are.
 

John Broomfield

Staff member
Super Moderator
#4
Looking for opinions / comments from an auditor's and user's viewpoint on a QMS system that has over 6,200 files spread across 685 folders.
Proud Liberal,

You could ask the auditee's IT department to provide you with usage stats on the QMS docs during audit planning.

From this you'd have an objective basis for auditing the effectiveness of their archiving (also know as control of records).

You may also have a basis for auditing the upkeep of QMS documents.

You may also find users are unclear of where to find requirements relevant to their processes and products. You may find that certain process owners are allowing their documentation to grow like topsy.

Then you could have a discussion with the QMS Manager or equivalent and the relevant process owners. You may find the system has failed to impart clarity, authority, care or competence.

Or it may be working just fine.

John
 
Last edited:

Pancho

wikineer
Super Moderator
#8
Looking for opinions / comments from an auditor's and user's viewpoint on a QMS system that has over 6,200 files spread across 685 folders.
The number of files is not a good measure of the usefulness of the QMS. And that you even measure the number of folders that contain those files is worrying.

Regardless of how many files you have, can folks get to the information they need within a few seconds? If it takes anyone more than 3 clicks or one search, then they probably can't. This makes the system not useful.

The "accessible at points of use" requirement is easy to meet with the right technology, even if you have hundreds of thousands of files.

Hierarchical file directories alone are not the right technology for anything more than a few dozen documents. Unfortunately, many will opt for "lean" or "minimal" documentation to shoehorn a QMS into just such file directories and get through a certification audit. But this shortchanges the organization: it leaves no good place or structure to deal with the growth in documentation that should come from capturing knowledge through the continual improvement cycle.

Instead of using file folders or paper binders to store your documents, create a small world network with them. You can do this with dedicated software or a database, or best of all, a wiki. Then don't hold back from documenting every little detail of your business through your CI process. Accessible documented details are quality.
 

somashekar

Staff member
Super Moderator
#10
1 company, 1 QM, 75 employees
6,200 files spread across 685 folders
Are all these documents and records under control ?
If so, find out if you can lighten your luggage.
Its like a Bank. The systems are same, the personnel and the resources must be adequate to operate and manage the size of Banking.
Then whether it is 500 various types of accounts or 50000. No big deal.....
 
Thread starter Similar threads Forum Replies Date
apestate Size of QMS / Size of company - What advantages do small, simple organizations have? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Minimum sample size - Guidance and statistical rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
J Control chart for huge sample size Statistical Analysis Tools, Techniques and SPC 9
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
J SPC - Stamping parts - Small batch size Statistical Analysis Tools, Techniques and SPC 6
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
E Correct way to certify hydrostatic testing when it is not 100% (and Sample Size) Various Other Specifications, Standards, and related Requirements 6
B Determining sample size for device sterility Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 5
F Bayes Success run Theorem for sample size during OQ&PQ Qualification and Validation (including 21 CFR Part 11) 4
M UDI size on packaging EU Medical Device Regulations 3
I Device modifications - Clinical sample size rationale EU Medical Device Regulations 5
G Stab Pin Size For Check Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
D Using "Particle Size Standard" templates as gauges - How to avoid giving a gauge # while using for process control? General Measurement Device and Calibration Topics 2
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
O Statistical justification of sampling size in V&V tests ISO 13485:2016 - Medical Device Quality Management Systems 5
T Sample Size for Design Validation Design and Development of Products and Processes 4
C AS9138 Sample Size Determination AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Marc Definition RFS - Regardless of Feature Size (GD&T) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
John Predmore What size pinhole can be reliably detected using visual inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
V Acceptable maximum RSD (relative standard deviation) for an sample size Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
E Sample size for design verification of variable in single use device Design and Development of Products and Processes 19
I Can subgroup size change daily? (X-bar & R) Capability, Accuracy and Stability - Processes, Machines, etc. 5
R Sample size for clinical validation/investigation EU Medical Device Regulations 4
R Process Validation sample size selection Statistical Analysis Tools, Techniques and SPC 0
optomist1 ASME Y14.5 Irregular vs Regular Features of Size Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
J Interesting Discussion Sample Size Determination for Medical Device Other Medical Device and Orthopedic Related Topics 9
P Is it possible to make an educated decision using a very very small sample size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
F Sample Size for Biocompatibility Tests Other Medical Device Related Standards 4
V Firmware Verification Testing & Sample Size Software Quality Assurance 1
R Determining Sample Size for Medical Device Component Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
S Surveillance Sampling Test - Determining Sample Size Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
H Sample Size Calculation (Confidence Interval and Reliability) - Medical Devices Reliability Analysis - Predictions, Testing and Standards 6
P Cleaning and Disinfection Validation Sample Size of 3? Other Medical Device Related Standards 2
V Sample Size Calculation for Image Analysis - Microscopy Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
G Sample Size, Significant Figures, Scale General Measurement Device and Calibration Topics 3
L Heated Sealed Packages - Sample Size for OQ (Operational Qualification) and PQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
Proud Liberal Cpk on Position w/ MMC on Location and Size Capability, Accuracy and Stability - Processes, Machines, etc. 3
P Frequency and Sample Size Requirements for an MSA Studies Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
V When and How to apply the Bayes Success Run approach for Sample Size Determination Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
N Sample Size Justification for Medical Device Shelf-Life Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
G Metal Scale (SIP-Societe Genevoise) change in size over time? General Measurement Device and Calibration Topics 8
C Process Qualification Sample size Document Control Systems, Procedures, Forms and Templates 6
G Sample size for IEC 60601-1-11 environmental tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
G IEC 60601-1-2 Sample Size issue Other Medical Device Related Standards 1
A How to calculate Mean and standard deviation without sample size in Minitab Using Minitab Software 5
Ron Rompen Particle Size Templates General Measurement Device and Calibration Topics 7
D What is the minimum Sample Size for Weibull Analysis Reliability Analysis - Predictions, Testing and Standards 12
O Design and Development Process - Does one size fit all? ISO 13485:2016 - Medical Device Quality Management Systems 13

Similar threads

Top Bottom