The best way to address this Document and Record Control scenario!

J

JaimeB

#1
Hi! I'm trying to implement doc/record control procedures in a company where there is virutally none...

Need some advice on the best way to address the following:

We have a document management system, it tracks all the goodies of the revision history. Awesome.

Several folks like to print out things like POs or RFQs and keep them for their own files.

Question:

Is a record/document out of control any time a soft copy exists, but an employee prints their own hard copy and makes notes on it? Does it depend on the type of notes (i.e what if the notes do not have any impact on the record, they are just for the employee's information and aren't necessary for anyone else to know)?

I am sure this question is rudimentary, but more than anything I'm trying to get my mind around how I will help my coworkers understand what is acceptable and unacceptable as we venture to implement document/record control. Your contributions are much appreciated!
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
There is certain to be some adjustment when moving documentation online. Some things are easier for many of us to use when printed, such as a blueprint.

And it's not necessarily a calamity to write clarifying notes on such a printout, but doing things like that takes a certain discipline.

Such notes cannot usually be changes to how things are done, or definitions of expected outcomes. We are expected to have engineering change control for that. But there may be special exceptions made; the organization gets to decide how and when to depart from the controls. For example, during a process's development phases there might not be official documented procedures but a series of handwritten notes.

If it is suitable to do so, this printed material could possibly be used as a record, with hand written recordings of outcomes against the document's defined expectations. That means a print, a form, etc.

I don't think these are rudimentary questions. But without knowing your industry and just what these documents are, it's hard to give a better answer.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#3
Howdy JaimeB,

You're following my Sig Line...good job.

The PURPOSE of doc control is have a record of the standard way of doing things that have been determined to need a standard way. The 'record' to be used as a reference of how we do things, the 'control' so that everyone uses the same reference.

You're now struggling through the PLAN.

Toward answering your questions: Make sure the PLAN accomplishes the PURPOSE.

"Is a record/document out of control any time a soft copy exists, but an employee prints their own hard copy and makes notes on it?"
Only if they use the notes as overrides to the controlled document. The reason that is a problem is that now not everyone is using the same reference, and you've defeated the PURPOSE.

If the notes are clarifications so that the controlled reference is more clear, then the purpose is achieved more fully. If the operator notes should be known to all...revise the document so everyone has the notes. If the notes conflict with the document, the document must win...not the notes, otherwise you've defeated the purpose.

Some people ban marking up controlled documents, some don't. Some use controlled forms, some don't. The PURPOSE is achieved when the things that need to be standard are standard (and documented), by pretty much any means. It is fairly normal to go through a number of revisions to the document based on feedback from the folks using it. It is important, however, to make sure that people on the floor are not "doing their own thing" in a process that has been determined to need standardization.

Make all the notes you want...as long as you are following the standardized process and know what that standard is.

Keep up the PROGRESS!

:2cents:
 

Mikishots

Trusted Information Resource
#4
Specifically, a controlled document is any document that is uniquely identified and bears a "snapshot" in time, i.e. has a revision level. The idea of course is to ensure you have a current document available for use at a specified location. Every controlled copy should have a watermark or statement defining it as such.

Where I work, anyone can make a copy of a controlled document with the understanding that if a non-conformance arises because of the use of an altered or obsolete document, they are responsible for the consequences. Users should also be cautioned that revisions will be forwarded only to the locations specified in the doc control distribution list; copies on local hard drives or printed copies at workstations will NOT be updated.

Notes made do not supercede the original text or images of the controlled copy. It's the responsibility of the users to forward any requested changes to doc control or the owner of the document for review; this needs to be stated in the document control procedure.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
The PURPOSE of doc control is have a record of the standard way of doing things that have been determined to need a standard way.
:confused:
The purpose of document control is to ensure that people have access to the data & information when and where they need it to carry out work that affects product conformity and customer satisfaction.
 

qusys

Trusted Information Resource
#6
Hi! I'm trying to implement doc/record control procedures in a company where there is virutally none...

Need some advice on the best way to address the following:

We have a document management system, it tracks all the goodies of the revision history. Awesome.

Several folks like to print out things like POs or RFQs and keep them for their own files.

Question:

Is a record/document out of control any time a soft copy exists, but an employee prints their own hard copy and makes notes on it? Does it depend on the type of notes (i.e what if the notes do not have any impact on the record, they are just for the employee's information and aren't necessary for anyone else to know)?

I am sure this question is rudimentary, but more than anything I'm trying to get my mind around how I will help my coworkers understand what is acceptable and unacceptable as we venture to implement document/record control. Your contributions are much appreciated!
Hi Jaime,
when the folks print the document you said, on the document it could be written " when printed, copy conforming to the original one residing on Company Documents database".
Clearly, numbers , words etc. inside the text shall not be modified, otherwise the change could create misunderstanding and mistake.
Notes that do not change the content could be allowed. You could also think about a blanket space in the foot at the document and regulated its eventual use, explaining the right use of it ( for istance, person to be contacted, cellular number, meeting to discuss an issue and staff like that). I also agree with what the other expertCovers said. It also dpends on the regulation of the industry where you work too.
see you.:bigwave:
 
J

JaneB

#7
If you keep the purpose of controlling documents clearly in mind, it should help guide you in communicating why it's done to people. Sidney said it well:
The purpose of document control is to ensure that people have access to the data & information when and where they need it to carry out work that affects product conformity and customer satisfaction.
Don't make it too cumbersome, too bureaucratic, too arcane or too damned difficult! Because if you do, they won't follow it and you'll go nuts trying to control it.

It will take a while to educate your people. Do allow for that, and don't get heavy - aim for understanding and expect it to take a little while. Keep using good inhouse examples, eg, 'well, if you print your own copy of this RFQ out and use that to refer to (instead of the official copy), isn't there some risk that you could quote the wrong price to a customer if it changed in the meantime, but you were still using the earlier copy? ?' (IF that's applicable or whatever's a good example).

You could (I hope) embed a 'printed date' in any print copy, which is a handy way of cross-checking if it's current. Strongly advise against putting in a a whole lot of words or a complex phrase that people won't understand. And there's no need in my opininon to run around plastering things like UNCONTROLLED COPY in 30 point bold red across everything. If you get an urge to do so, I suggest you lie down until it passes.

Find out why people are printing 'POs or RFQs ' and what they're using them for. Assess the risk if those are uncontrolled. If it's medium-high, you need to do something. If it's very low, you probably don't.

As for the writing, yes, if it's simply working notes like 'difficult guy to deal with, make sure call back tomorrow!' it doesn't matter. Whereas if it's 'XYZ customer always wants things in triplicate' that's a bit more something that could be/should be in the system.
 
Q

QAPam

#8
I have a related question, so I'm adding it to this post.
What about "living records"... we have an approved supplier list, and a receiving inspection log. The receiving inspection log gets updated every day... as a new company the Approved Supplier List is updated frequently. OUr Record retention states 7 years... does this mean each iteration has to be saved? For the receiving log that would be overwhelming...Is there another way around this? thanks
 

insect warfare

QA=Question Authority
Trusted Information Resource
#9
I have a related question, so I'm adding it to this post.
What about "living records"... we have an approved supplier list, and a receiving inspection log. The receiving inspection log gets updated every day... as a new company the Approved Supplier List is updated frequently. OUr Record retention states 7 years... does this mean each iteration has to be saved? For the receiving log that would be overwhelming...Is there another way around this? thanks
NO, there is no need for each iteration to be maintained separately. Good record retention comes down to how you define the rules, and also how you define the "exceptions" to those rules. Exceptions are generally put into place to allow more flexibility, so if done appropriately, it can eliminate a lot of worry. This post contains an example of a record retention schedule that helped defined my exceptions (refer to the guidelines section to understand what I mean).

Brian :rolleyes:
 
#10
I have a related question, so I'm adding it to this post.
What about "living records"... we have an approved supplier list, and a receiving inspection log. The receiving inspection log gets updated every day... as a new company the Approved Supplier List is updated frequently. OUr Record retention states 7 years... does this mean each iteration has to be saved? For the receiving log that would be overwhelming...Is there another way around this? thanks
Change your retention period. Usually, retention is based on some form of need to review/analyze and possibly retain info for other purposes (such as patent protection). And RI log should be used for reporting on supplier quality and then pitched if it has no reason to be kept longer.
 
Thread starter Similar threads Forum Replies Date
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
G Best way to calc uncert for measuring microscope without duplicating repeatability? Measurement Uncertainty (MU) 2
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
optomist1 Best Optical Comparators General Measurement Device and Calibration Topics 9
qualprod Best practice to ensure inputting of data in production Lean in Manufacturing and Service Industries 19
M Best profilometer for the money General Measurement Device and Calibration Topics 22
P Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020 Other Medical Device Regulations World-Wide 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
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
S What is the best method to bond urethane foam to urethane foam? Manufacturing and Related Processes 4
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
E Best way to keep up with pharmaceutical quality knowledge and current affairs Service Industry Specific Topics 1
K Best Measurement Systems Demos in California? General Measurement Device and Calibration Topics 1
qualprod Best approach to get a real value as average? Statistical Analysis Tools, Techniques and SPC 6
CPhelan Best metrics for monitoring low volume (<1000) parts per vendors Supply Chain Security Management Systems 1
DuncanGibbons Best practice for identifying "items" of parts for DFMEA analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
I What kind of wine best complements the Friday that you close out your external audit findings? Opinions are welcome. Coffee Break and Water Cooler Discussions 12
I Non-Conformance vs OFI -- your best descriptions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 61
A What are Practical data center best practices IEC 27001 - Information Security Management Systems (ISMS) 1
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
S Best software for customer support/complaints? Customer Complaints 0
R Bill of Materials for a complex product - Industry best practice ISO 13485:2016 - Medical Device Quality Management Systems 2
G Oversized Threads - What sized stab pin would be best to quickly check for oversized thread holes General Measurement Device and Calibration Topics 5
D What is the best software used for the pharma compliance management? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
M Informational MHRA launches consultation on how to best engage patients and the public Medical Device and FDA Regulations and Standards News 0
optomist1 Mobility Field Manufacturing Best - Worst Practices Manufacturing and Related Processes 5
qualprod Best criteria to measure Corrective Action effectiveness - Poor Maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
N Best practices for capturing audit objective evidence in a practical manner? Internal Auditing 3
S How to Learn all aspects of ISO 27001:2013 | The best way to grab the knowledge on 27001:2013 (Step by Step) IEC 27001 - Information Security Management Systems (ISMS) 7
I Best visual description for SOPs? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
Z Best Practices - small volume medical device tube cutting (0.020" to 0.080" OD)? Manufacturing and Related Processes 3
M Over-labelling - Any requirements or best-practices? Other Medical Device Regulations World-Wide 0
M Informational DITTA White Paper on Cybersecurity: Best Practices in the Medical Technology Manufacturing Environment Medical Device and FDA Regulations and Standards News 0
M Informational BSI – MDR Documentation Submissions Best Practices Guidelines Medical Device and FDA Regulations and Standards News 0
K Which clause would best fit this Nonconformance? (Supplier Related) Internal Auditing 2
P How to have employees buy-in of quality procedures. Best practices? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Expiry date vs. Best Before Date - Reagents ISO 13485:2016 - Medical Device Quality Management Systems 9
C Will anyone please share training material for ISO:13485:2016 for best practices Training - Internal, External, Online and Distance Learning 0
E Best GD&T training - Your suggestions and recommendations please Training - Internal, External, Online and Distance Learning 3
M Best Practice for setting tolerances on a Drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
M PCBA Drawing Best Practices IPC Class 3 ISO 13485:2016 - Medical Device Quality Management Systems 1
Ron Rompen Best Practices in CMM Correlation Studies General Measurement Device and Calibration Topics 3
B Best place is to purchase IEC 60417 labels that will pass markings test IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P Best approach to tackle difficult certifications Career and Occupation Discussions 2
E Best Ways to Close a Project APQP and PPAP 3
S Opinions on the "Best" CMM for High Accuracy Machining General Measurement Device and Calibration Topics 9
C What is the best ISO 22000 template pack to purchase? Food Safety - ISO 22000, HACCP (21 CFR 120) 2
M Best Type of Grease for Vex Plastic Gears Manufacturing and Related Processes 5
W Which is best IAS academy in Chennai Career and Occupation Discussions 1

Similar threads

Top Bottom