Control of PC (computer) based Documents

qcman

Registered Visitor
#1
We are a extrusion/fabrication job shop with over 300 active jobs, some running all the time and others once every few months. I have a dos based area on the company main frame. I want to use this to create a list for the set up men to use as a job specific PM check list that is printed out along with the set up job card. The entries in the program will be on going as issues come up. Everyone will have access to it and a few key people will have write access to it. The print out and resulting record will be controlled. After it's up and running I would guess there would be entries made on a weekly bases if not daily. Current doc control procedure includes a DCR or ECR for every change which would not be feasible for a dos based program like this. Since what is read on the screen at any given time would be the most current and the fact that only a few key people have write access to it be all the control I need to satisfy ISO ? Believing an auditor will not except the last statement :lol: any ideas on a simplified control I could use that would allow me to make entries to it on the fly so to speak ?
 
Elsmar Forum Sponsor

BradM

Staff member
Admin
#2
Re: Control of PC based Documents

Let me make sure I am clear. You will be writing "recipes" in DOS, that will print up for the operators. The hard copy will be used by the operators.

Do I understand that you control the hard copy by DCR/ ECR? Exactly what aspect of the printed form is controlled? Is there a general format or something?

If you have information (software) that generates a specific set of instructions that gives quality guidelines, I would think control should be in place. Otherwise, even the few individuals could make a change (good or bad), and no one would know any difference.

You might could set up a log sheet for the system documenting changes. It could have a simple sign off spot to approve the software change.

I'm not really approaching this as "ISO says to do this/not do this". I'm merely suggesting that it's been my experience that you greatly desire some kind of log/history/tracking mechanism of software changes (minimally). Better is a system (and it can be simple) where there is a sign off/ signature for the change before it is made.
 
Q

qualitygoddess - 2010

#3
Re: Control of PC based Documents

Using the control method you describe, which I interpret as 'only a few knowledgeable people can make changes, so it must be OK', I have concerns about meeting the requirements 4.2.3 a) and b). The DCR/ECR system helps you meet these requirements, because there is a review of the change and an approval of the change.

How would you plan to approve the documents prior to issue, and to re-approve these documents when changed? Can you keep a master log of changes, which could also be 'approved' by the correct party? Or is there a way to incorporate a history section on the DOS checklist? It could be completed and approved prior to saving the document for later retrieval by the user. You would certainly need to change your document control procedure.
 
Last edited by a moderator:

qcman

Registered Visitor
#4
Re: Control of PC based Documents

The entries in the program would be like this.

22203 pierce/notch operation

Check all punches for sharpness
Check clamps for proper function
Check air lines for leaks
Check proximity switches for damage/function

This type of check list would be printed and given to the setup man when assigned the setup job. Once he/she completes the job and check list it is turned into the office and is now a record along with the job card. Printed at the bottom is *Void after 48 hours* which is another part of our doc control and I am ok with that part of it. Our doc control else where is very good but does not really fit this plan. I like the history idea and wonder if I make it so 2 people have to sign off to approve change? Also would typing your name at the top of the page along with date be acceptable proof or do I need a seperate long?
 
Thread starter Similar threads Forum Replies Date
Gman2 Control of Documents and (FORMS) on a Computer Network ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
H ISO 9001:2008 Clause 7.6 Control of Monitoring and Measurement (Computer Software) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K I.T. Management in Clause 4.2.3? Control of Computer Data Backup and Access Security ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Medical Diagnostic Equipment Control Computer Repair Other US Medical Device Regulations 3
T Medical Device Manufacturer Document Control Computer System Validation Qualification and Validation (including 21 CFR Part 11) 4
W Computer Software - ISO 9001 Clause 7.6 Control of Monitoring and Measuring equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Control of monitoring and measuring devices - Computer forensics company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Control of Computer Generated Forms - TS 16949 requirements Document Control Systems, Procedures, Forms and Templates 1
D Control of Computer Generated (Electronic) Forms - TS 16949 Control Requirements Document Control Systems, Procedures, Forms and Templates 9
D Control Number for Class III and IV devices Canada Medical Device Regulations 0
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C UDI Questions on Control Units Other US Medical Device Regulations 6
A Quality Control Datasheets Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
M Control-self assessment Internal Auditing 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
A Prototype control plan FMEA and Control Plans 2
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
W FMEA - Current control and occurrence rating FMEA and Control Plans 3
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 1
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
A Fabric roll inspection - What type of Control Chart to use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C Monitoring and Control Instruments RoHS, REACH, ELV, IMDS and Restricted Substances 3
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
T Risks arising from control measures vs. ineffective control measures ISO 14971 - Medical Device Risk Management 11
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
T Linking Control Plans and PFMEA's FMEA and Control Plans 3
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 12
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
Z Putting back excluded rows/data points in a control chart Using Minitab Software 0
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
D All Dimensions listed on control plan FMEA and Control Plans 10
W Need for current design or process control FMEA and Control Plans 2
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10

Similar threads

Top Bottom