Is there a difference between form control and document control ?

T

Tarek1985

#1
I have had third party audit last week and he has recorded NC for documents control stating that during the audit he has noted that the company provide issue status (issue No. and date) for the form which is not required by ISO 9001 and what is important on the other hand the issue status is required for the data/information inside form not the form design/template
for example
1- internal audit plan has issue status as a form but if there is change in the date/information like areas to be audited according to him the issue status shall be changed for this purpose not changing of the form design
2- job description form has issue No. and issue date for the form but what if i modify in the job description information. then according to him i shall change the issue status (Number and date) for the information which have been changed not the form

I am really confused .. Is the issue status for the form design/template or the information inside the form? please provide me with your experience in that...
 
Elsmar Forum Sponsor
#2
Re: HELP!! the difference between form control and document control

The issue number of the form should only change if you amend the information the form is designed to collect. The form (template) should not be up issued, every time it is completed with the information required.
 
#3
Re: HELP!! the difference between form control and document control

Your auditor doesn't understand what they are talking about. Reject the NC back to your CB and ask them not to send that auditor again. Frankly, you have nothing to fix. The auditor is from another planet...
 

dsanabria

Quite Involved in Discussions
#4
Re: HELP!! the difference between form control and document control

Your auditor doesn't understand what they are talking about. Reject the NC back to your CB and ask them not to send that auditor again. Frankly, you have nothing to fix. The auditor is from another planet...
Agree with AndyN - the document (template should not change unless it was modified. The information in the document does not change the document (Template). Appeal the NCR to your registrar and yes - dis-invite the auditor.
 

somashekar

Staff member
Super Moderator
#6
I am really confused .. Is the issue status for the form design/template or the information inside the form? please provide me with your experience in that...
Do you have a date field within the form design / template that denotes the date of the active information input into it ?

Have you kept the issue status (Number and date) of the form design / template outside of the form design / template and perhaps in small font at the left bottom of the sheet (.. for example)

Please give more details as Kronos says above ~~
 

Mark Meer

Trusted Information Resource
#7
We have a caveat in our documentation control procedure that basically states that unless a form is explicitly prescribed by procedure, work-instruction, etc., any medium of data collection is acceptable provided:
  • All required data is collected
  • The medium complies with general documentation control requirements (identification, legibility, retrieval, storage...etc.)
  • The data is subject to the same review & analysis as with all other data

In these cases (where forms are not explicitly prescribed), forms are exempt from control provided there is adequate oversight that the above criteria are continually met.
 

dsanabria

Quite Involved in Discussions
#8
We have a caveat in our documentation control procedure that basically states that unless a form is explicitly prescribed by procedure, work-instruction, etc., any medium of data collection is acceptable provided:
  • All required data is collected
  • The medium complies with general documentation control requirements (identification, legibility, retrieval, storage...etc.)
  • The data is subject to the same review & analysis as with all other data

In these cases (where forms are not explicitly prescribed), forms are exempt from control provided there is adequate oversight that the above criteria are continually met.

HHMM... 2 set of rules - nothing wrong with it but most people aim for simplicity and one set of rules for documents that meets all criteria.

I like the concept and if they work for you - :agree1::agree1::agree1:
 
T

Tarek1985

#9
J0anne: the problem is he consider that some of the forms we use it in our company are actually documents like for example (internal audit plan/job description/master lists) ..

Andyn / Dsnabria: unfortunatly i can't do this because i don't have authorization for that and furthermore My Manager (management representative) has singed audit report.

Kronos147: the NCR as stated by the auditor is as follows:
The client did not fully comply with the requirements of the clause in that evidence of poor document control was seen:.
OBJECTIVE EVIDENCE:
1) Job descriptions were seen for three separate managers. However, the same document number, HR/701/F/7 Issue 2, 23/09/14, was used on all. This referred only to the document template and not to the documented content. This was seen in several other cases, where a document template had been classified as a form and the documentary content had no issue control.
2) The blank audit plan form QA/1002/F/1 issue 3 does not include the names of the areas to be covered over the audit plan period. This is unlikely to change from plan to plan.

Somashekar: he checked internal audit plan and found that the column which includes the areas to be audited (process/procedure) has modified by adding another area (sales) and then he found on the header of the internal audit the issue status and then asked me is that the issue of the change of the areas to be audited i told him no it is the issue status of the form (design) itself.

thanks all for attempting to help me :) :) :thanks:
 

John Broomfield

Staff member
Super Moderator
#10
J0anne: the problem is he consider that some of the forms we use it in our company are actually documents like for example (internal audit plan/job description/master lists) ..

Andyn / Dsnabria: unfortunatly i can't do this because i don't have authorization for that and furthermore My Manager (management representative) has singed audit report.

Kronos147: the NCR as stated by the auditor is as follows:
The client did not fully comply with the requirements of the clause in that evidence of poor document control was seen:.
OBJECTIVE EVIDENCE:
1) Job descriptions were seen for three separate managers. However, the same document number, HR/701/F/7 Issue 2, 23/09/14, was used on all. This referred only to the document template and not to the documented content. This was seen in several other cases, where a document template had been classified as a form and the documentary content had no issue control.
2) The blank audit plan form QA/1002/F/1 issue 3 does not include the names of the areas to be covered over the audit plan period. This is unlikely to change from plan to plan.

Somashekar: he checked internal audit plan and found that the column which includes the areas to be audited (process/procedure) has modified by adding another area (sales) and then he found on the header of the internal audit the issue status and then asked me is that the issue of the change of the areas to be audited i told him no it is the issue status of the form (design) itself.

thanks all for attempting to help me :) :) :thanks:
Tarek,

Something or someone caused your auditor not to have confidence in your system's control of documented information.

Your template for job descriptions seems to have a unique identifier. But this does not uniquely identify the actual individual job descriptions. You could use the job title as the unique identifier for each job description instead.

With the second example of evidence your auditor is expressing his opinion. This is not evidence of a nonconformity. After all you may train and monitor your auditors well enough for them not to use a standardized form for every internal audit.

Your auditor may be thinking about the standardized form he has to use but he should realize that internal auditing is different.

Your documented procedure or form for internal auditing should say something along the lines of the auditor determines the audit sample sufficient to fulfill the audit objective and the auditor records the sample to be taken and actually taken on QA/1002/F/1.

Please bear in mind that records are controlled not by the document code but by a unique identifier for the record itself which in the case of document code QA/1002/F/1 would be the unique number you assign to each internal audit.

John
 
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