Manufacturing Software + Controlled Documents

M

mshell

#1
O.K. I need input. If you have Manufacturing Software that generates:

Purchase Orders
Sales Orders
Pick List
Production Schedules
Shipping Schedules
(you get the idea)

Are these documents "controlled" via the software or must they have a unique document number?

mshell :bigwave:
 
Elsmar Forum Sponsor
R

Randy Stewart

#2
We use Made 2 Manage and it allows us to place items in the footers of the documents. The only item, from your list, that we control is the PO and that is mainly for retention. Sales orders are generated by the software, therefore it is kept internal. Remember the purpose of Doc Ctrl - to avoid inadvertant use of an obsolete document. In essence you are saying that the user will be notified of changes, that's all.
 

SteelMaiden

Super Moderator
Super Moderator
#3
No document requires a number, if that is what you're asking. Probably anything that you print from your software has some sort of report title, right? (Like CompanyZYX Pick List)

So, then, the question becomes what if something changes, and you need to revise your pick list? How do you know that the printed copy that is given to your stocker, or whatever you call him/her, is the current one? All of our sales orders, purchase orders, schedules and on and on are computer generated. We typically go right off the computer for all work, but if a paper copy needs to be generated, it is done just prior to performing the work so that it is "current". If changes are made in the computer there is a change log maintained. So if the paper was printed on 10/13/2003 1030.25 and the computer does not match it at 1537.50 you can review the change logs to see that the a change was made at 1520.30 while the load was put together. In this case we would expect to have change information relayed directly to the loader to inform him of the updates. (our system does not allow changes after the "task" is marked complete, without proper securities and some pre-set steps)

Did this help???
 
#4
mshell said:
O.K. I need input. If you have Manufacturing Software that generates:

Purchase Orders
Sales Orders
Pick List
Production Schedules
Shipping Schedules
(you get the idea)

Are these documents "controlled" via the software or must they have a unique document number?

mshell
There are two questions:

1) What does the standard say?

2) What does your documentation say?

In many cases, the control is through the software. This is particuarly true if the forms are filled in on-line. If blank forms are printed and then filled in, you run into a different set of necessary controls.

SteelMaiden is quite correct in "No document requires a number" (at least from an ISO standpoint. If your documentation says otherwise, I would change it.) I think 4.2.3 d) is probably the key: "to ensure that relevant versions of applicable documents are available at points of use." Just about everything else in 4.2.3 supports that sub-clause.

Go down each "Shall" is 4.2.3 and answer where your documentation system meets and doesn't meet those requirements. Then march on from there.
 

CarolX

Super Moderator
Super Moderator
#5
mshell said:
O.K. I need input. If you have Manufacturing Software that generates:

Purchase Orders
Sales Orders
Pick List
Production Schedules
Shipping Schedules
(you get the idea)

Are these documents "controlled" via the software or must they have a unique document number?

mshell
mshell,

Are you looking to identify the document, or control a document that changes and you need to control those changes?

If you are looking just for identification - use the title, a document number is not needed.

If you are looking for control of the document - I would say, if it matters to you, then you need some type of control.

For example...Sales Orders...do customer's make frequent changes after they have ordered something from you? If they do, then you need to identify this in your system.

Steel's example of the pick list was excellent example of a need to have control of a document-in this case...a pick list is a work instruction.

Hope this helps a bit.
CarolX
 
M

mshell

#6
Thanks Guys,

Our documentation states that documents created by our organization will be assigned a document number however, if I add a statement declaring that documents generated by the manufacturing software are printed on an as needed basis, controlled within the software, and recalled when changes are required would that cover us?

mshell :bigwave:
 
G

Groo3

#7
mshell said:
Thanks Guys,
Our documentation states that documents created by our organization will be assigned a document number however, if I add a statement declaring that documents generated by the manufacturing software are printed on an as needed basis, controlled within the software, and recalled when changes are required would that cover us?
mshell :bigwave:
Probably... I would however recommend that if the software is "The system of Record", that any documents printed from that software are considered to be a report, only accurate as of the date and time it was printed (hopefully the reports have a creation date on them?). If it makes sense in your organization to "control" those reports, including the recall of those documents when changes are required... OK, that works too - but you may not need to go to those lengths... You should be OK as long as the individuals who use the reports understand that there is a limited usefulness to the information on the reports and that they should discard them and print new reports when appropriate.
 
M

mshell

#8
That is how the system works. For example, if a customer places an order and the order is generated then suddenly the customer decides to add 4 more parts, we recall the initial order and issue a new one. These documents eventually become part of our records.
 

RoxaneB

Super Moderator
Super Moderator
#9
We've taken a slightly different approach by the sounds of it. Software that impacts our Business Management System is listed in a Work Instruction detailing all Controlled Software. The list includes such items as:

  • Document Control Software
  • Purchasing Software
  • Order Entry Software
  • Etc.

When software is modified (thankfully, not too frequently), the WI is updated with the correct version number of the software. Details of the changes made to the software are maintained within the software's programming or with the person responsible for maintaining the software - location indicated in the Work Instruction.

So, a document, such as Purchase Order, has no document identification on it as it is generated via a controlled software package.
 
M

mshell

#10
We use one software program for all of those items. The software program is mentioned throughout our procedures and instructions. We use the term Manufacturing Software rather than a brand name (just in case we decide to change). If modifications are necessary, the electronic copy is updated to reflect the new information, the hard copy is recalled and an updated hard copy is issued.

The reason for this question is that I worked for an organization that printed off a hard copy of EVERY electronic screen in their manufacturing software and assigned a control number to it. I did not see any added value to this as the rev level did not change in the five years that I was there. I do not want to create that type of situation here and in my opinion, the documents are controlled within the software program. It is only the hard copies that we need to be concerned with.
 
Thread starter Similar threads Forum Replies Date
S Manufacturing Execution Systems Software Costs Manufacturing and Related Processes 0
U Manufacturing vs. Production for Medical Device Software in a FDA context 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Stijloor ERP (Enterprise Resource Planning) Manufacturing Software Recommendations Manufacturing and Related Processes 3
R PMA (Parts Manufacturing Approval) Supplement - Labeling Software Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Work Instructions for manufacturing software Document Control Systems, Procedures, Forms and Templates 2
J MRP / ERP Software Systems - Small medical laser manufacturing company - ISO 13485 Quality Assurance and Compliance Software Tools and Solutions 6
F Nonconformance System Software for a small manufacturing company Quality Assurance and Compliance Software Tools and Solutions 4
B Lean Manufacturing Software Advice and Suggestions Lean in Manufacturing and Service Industries 2
T Visual Manufacturing MRP system software - Who else uses their MRP software? Quality Assurance and Compliance Software Tools and Solutions 2
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 4
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
DuncanGibbons Additive Manufacturing Processes Thread Manufacturing and Related Processes 5
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
H Line Balancing in Backpack Manufacturing Manufacturing and Related Processes 2
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L SAE AS9145 vs. SAE AS6500 (Manufacturing Management Program) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 4
qualprod Automation in manufacturing - Print Shop ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
P Manufacturing equipment (e.g.: Dental Welder): medical device or not? US Food and Drug Administration (FDA) 5
S Contagious Diseases in Medical Device Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 5
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Z US Manufacturing Site Closing, device manufactured elsewhere Medical Device and FDA Regulations and Standards News 1
L Manufacturing site expansion - When to notify your NB EU Medical Device Regulations 3
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N China - Start manufacturing before change approval? China Medical Device Regulations 1
J Manufacturing procedure / work instruction depth ISO 13485:2016 - Medical Device Quality Management Systems 12
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Looking for China Good manufacturing practice China Medical Device Regulations 1
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
C Design Control - Ways of capturing inputs from manufacturing Other Medical Device Related Standards 5
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
K Differences between Manufacturing Process Audit & Layered Process Audit Lean in Manufacturing and Service Industries 4
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 5
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
V Manufacturing without a Formal Drawing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Is there a standard / rules pertaining to eating in medical device manufacturing area? Manufacturing and Related Processes 5
qualprod What is the Normal Flow in an ERP for Manufacturing? Manufacturing and Related Processes 0

Similar threads

Top Bottom