Control numbers for records

T

Tyler C

#1
Hey everyone,

I have a question about control numbers for records, and it may be a stupid question so bare with me. Something my auditor said triggered this question, and I couldn't find anything in the standard, nor any other thread here.

So, I will just ask. Do record's need control numbers?

My auditor told me, for example, the control number of a form controls the structure of the form, not the info on it, and the info on it becomes a record. Since most forms become records, is the control number of the form then the control number of the record? Or, is it still the control number of the form only, and the record doesn't have a control number? If the control number of the form does become the control number of the record, is it okay to be the same number, or does the fact that it is now a record constitute a new control number?

This seems like it should be a clear, easy answer, but I cannot figure it out. Any help would be greatly appreciated.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
I think there is a definition issue here. Forms are typically controlled documents. Thus, most forms have a number or other identifying aspect. It could be the name of the form its self. Then again, typically forms need revision control (remember, prior to having data entered it is essentially a document).

This is different than a record which is a form which has been completed. The form number will be different than the record number. Think of it this way - Some restaurants give the wait staff a pad of order blanks. Most have a sequential number on each slip in the pad so at the end of the shift/day they can reconcile each order taken. That said, I rarely eat out, but I do watch a lot of old movies, so I really don't know how they handle this stuff these days. I'm sure it depends upon how automated/electronic the restaurant is.

So - I *assume* that by "control" number the auditor was meaning the form should have revision control and that the form number and revision level should be printed on the form. Each record its self would have the form number and revision as well as an additional number to identify the specific record.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#3
Take a look through this forum regarding control of forms as well.....there is a lively debate on that one as well....

fwiw, we do not "document control" records at all...we retain them. Most forms are also not controlled, though some are...
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Agreed, but we come to definitions. I agree "document control" isn't typically applied to records. Then again, the term "document" is a wide brush. A record can be classified as a type of document. We just normally don't think of it that way.

E.g. from Google:

noun

doc·u·ment: document; plural noun: documents
ˈdäkyəmənt/

1. A piece of written, printed, or electronic matter that provides information or evidence or that serves as an official record.

Synonyms: official paper, legal paper, certificate, deed, contract, legal agreement;

Many industries require control of records and the more regulated the industry, the more significant control of records becomes (also see "traceability"). A company may "retain" records, but as I have pointed out in highly regulated industries record retention and traceability of various records is often a legal and/or regulatory requirement.

The same is true of forms - What form(s) are or are not controlled depends upon the industry and the product.

That is why we discuss these issues here and try to get as much information from the original poster as we can so that we can address their specific scenario. Making wood screws for general use, for example, a company will have a significant leeway in what documents are controlled, what records are retained and such. Aerospace, drugs, medical devices and food are examples of industries in which legal and regulatory requirements for what documents have to be controlled, what records have to be not only retained (not to mention their retention time), but also "controlled" (traceability) come into play.
 
T

Tyler C

#5
Excellent discussion. I don't feel so stupid for asking the question anymore. On my forms, I do have the revision history along with the rev level and control number, but I don't have a system for a new control # on records once the form is complete. That is my main concern, we will have blank forms and completed records with the same exact control number and rev level.

I do also agree with Ninja that it almost seems silly to control records because a record shouldn't be edited. Once it is filled out and complete, that is the record. So, there won't be any future revisions on the completed record, just the blank form document.

But, after looking back at the standard, it seems records shall be controlled just as documents are (this is why I need help, I just keep talking myself in circles...).
 
Q

QAMTY

#6
We manage this issue in this way:
The form has its document name, e.g for-plant-001, when we change something on the form ,we update the revision,e.g.to 01.
When this form is filled up, it becomes in a record, suppose you use it twice a day to check an equipment in a plant,in the morning and at night,well you take such form,and is filled up,and when you save/store it,it is save like this, for-plant-01 morning checking,and the other, for-plan-Night checking, that way both are identified.
You can use any method for the numbering.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#7
... I do also agree with Ninja that it almost seems silly to control records because a record shouldn't be edited. Once it is filled out and complete, that is the record. So, there won't be any future revisions on the completed record, just the blank form document...
In an ideal world.

First, again, it depends upon the importance of the record(s) as well as statutory, regulatory, and/or legal aspects of the business/industry/product.

Second, and most importantly, people do change records. Sometimes it is minor changes on insignificant records. An example - Written time cards. Other times it is to cover up activities (another example). If you remember the Value-Jet crash, it was determined that oxygen generators were incorrectly labeled and after the cause was determined the people who were supposed to have checked them went back and falsified (changed) their entries. This was determined by forensic analysis of the records.

Another very common aspect is incomplete records which are completed "after the fact" with what is often false information.

And, sometimes a problem of one kind or another is identified and a record is legitimately changed. When I worked in DoD and regulated industries there was the "One Line Through" rule, where a change to a record was allowed providing no entry was made illegible ("One Line Through") and that the change was initialed and dated by the person making the change. I have been in many companies where "white-out" was prohibited on the premises - Period.

After about 30 years of working with various businesses in quite a few different industries I have seen so many changed (and in many cases incomplete) records, for so many different reasons, sometimes benign, sometimes dangerous, that I would never assume a record is always completed and that's it - That it never changes. Whether it is significant or not depends upon the specific scenario. In some companies, even telephone call records are considered important enough to keep.

Just my :2cents:
 

hogheavenfarm

Quite Involved in Discussions
#8
We do not 'redesignate' any form numbers, we just file them for traceability. My GIT-001 form (General Inspection and Test) is a calibration form for calipers. It has a number (GIT-001) and a revision date and level. Thats all it will ever have, even when filled out and retained as a record, it is just filed with the appropriate instrument number. Job records(forms) are filed in the job numbers, and so on. No need to over complicate it.
 

Kronos147

Trusted Information Resource
#9
As I re-write procedures for our AS9100 Rev. D transition, I added a statement to our "Control of Documented Information" procedure that it is the format, not the content, that we control.

Yes, and we retain the completed documented information as evidence of conformance.
 
T

Tyler C

#10
Excellent points Marc. I hadn't thought of that, but now I do realize that there are times records are changed. I guess I was living in an ideal world like you said.

I do like the strikethrough and initial process. We use this method as well for things like the time cards and it works sufficiently.

Thank you everyone for your input. I have buckled down and just included the control numbers for our records because that is what our record control procedure says. You have all given me great insight for the next revision though!
 
Thread starter Similar threads Forum Replies Date
M Document Identification and Control Numbers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Changing Document Names/Control Numbers and Obsoleting Document Control Systems, Procedures, Forms and Templates 5
S Do you control your policies with control numbers? Document Control Systems, Procedures, Forms and Templates 10
D Document Revision Numbers and Control of Documents Document Control Systems, Procedures, Forms and Templates 18
D Assigning numbers to control plans etc. FMEA and Control Plans 7
J Control Numbers - Do you have to give a control number to every form you use? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B PPAP Applicability - 10,000 Part Numbers - Control Plans for ALL part numbers? APQP and PPAP 18
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 7
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
B Control chart and sample time Statistical Analysis Tools, Techniques and SPC 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 5
J Control chart for huge sample size Statistical Analysis Tools, Techniques and SPC 9
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
L AS5553 Clause 3.1.7 e "Control packaging material ..................reused" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
T Attributes SPC study - Attributive control (Go gage) Statistical Analysis Tools, Techniques and SPC 5
K Process Mapping - Inputs/Outputs/Detail Activities/Control points/Measurement? Process Maps, Process Mapping and Turtle Diagrams 4
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
D Infrastructure: Equipment, Work Environment and Contamination Control ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Relabeler for patent expired product - design control responsibilities? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J How to make Quality Control plans Quality Tools, Improvement and Analysis 5
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
D Supplied Product on Control Plan - Lot ranging in 40,000 pcs per product FMEA and Control Plans 3
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2

Similar threads

Top Bottom