Documentation to WI (work instruction) or QAP (quality assurance plan)

W

woodsjo

#1
#1
Good Morning

I am trying to set up a QMS(9K2K) ( This is my first assignement an ISO Quality person and previously I was a Mfg Eng) and need some thought on how inspection forms should be incorporated in to the system. I am trying to fulfill the shalls, verifyies, documents, controls etc etc........

My question is the following;

Should I reference the inspection procedure in the Work Instruction or the Quality Assurance/Standard Operating procedure ?
If I reference the testing / inspection in the WI do I then reference the WI to the QAP/SOP?
I know I need to control the recording forms but do I also need to control the testing /inspection procedure ?

If this has been discussed please direct me to the location, Otherwise I thank you for your feedback.
 
Download Free White Paper
Elsmar Forum Sponsor
D

db

#2
#2
Welcome

woodsjo said:
Good Morning

I am trying to set up a QMS(9K2K) ( This is my first assignement an ISO Quality person and previously I was a Mfg Eng) and need some thought on how inspection forms should be incorporated in to the system. I am trying to fulfill the shalls, verifyies, documents, controls etc etc........

My question is the following;

Should I reference the inspection procedure in the Work Instruction or the Quality Assurance/Standard Operating procedure ?
If I reference the testing / inspection in the WI do I then reference the WI to the QAP/SOP?
I know I need to control the recording forms but do I also need to control the testing /inspection procedure ?

If this has been discussed please direct me to the location, Otherwise I thank you for your feedback.
Click to expand...
Frist of all, Welcome to the Cove!!! :bigwave:

To answer your question, first ask other questions. What is the difference between the QAP/SOP and the Inspection Procedure? How does each relate to the WI? Do you need to reference up (from a level III to a level II)?

The key is to make sure your operators/inspectors have all of the information they need. You might find that you need to refer to both documents, or perhaps neither.

As far as controlling the testing/inspection procedure, if they are used to do a job, I would control them.

Hope that helps
 
M

Mike S.

Happy to be Alive
Trusted Information Resource
#3
#3
woodsjo said:
I know I need to control the recording forms but do I also need to control the testing /inspection procedure?
Click to expand...
Welcome to the Cove. As usual I think db gave good advice. Do what works for you and your employees and what makes sense. Involve the users of the documents.

As to needing to control the recording forms, that depends on what you mean by that, IMO. The completed forms/data needs to be kept as a quality record based on what you say you will do to comply with 4.2.4, however, the blank forms themselves do not need to be controlled unless they contain instructions. If the blank form is just an organized place to write data it does not require formal control IMO. I would definitely control testing /inspection procedures.

Hope this helps.
 
D

db

#4
#4
Mike S. said:
...however, the blank forms themselves do not need to be controlled unless they contain instructions. If the blank form is just an organized place to write data it does not require formal control IMO. I would definitely control testing /inspection procedures.

Hope this helps.
Click to expand...
I would agree with that statement.
 
W

woodsjo

#5
#5
db said:
Frist of all, Welcome to the Cove!!! :bigwave:

To answer your question, first ask other questions. What is the difference between the QAP/SOP and the Inspection Procedure? How does each relate to the WI? Do you need to reference up (from a level III to a level II)?

The key is to make sure your operators/inspectors have all of the information they need. You might find that you need to refer to both documents, or perhaps neither.

As far as controlling the testing/inspection procedure, if they are used to do a job, I would control them.

Hope that helps
Click to expand...
Dave

I think what I am trying to accomplish is to relate the WI's to the QAP. I then think that I am trying to relate the test/inspection procedure to the WI. I am then trying to relate what form I need to use to record the data after my inspection/test procedure has been completed and document the required information(this would complete my QMS pyramid). Does this approach make sense ? How do I control the test / inspection procedure if it is a std industry test ? Is there a different way I should be reviewing ?

Thanks for your reply

John
 
W

woodsjo

#6
#6
woodsjo said:
I know I need to control the recording forms but do I also need to control the testing /inspection procedure?
Click to expand...
Mike S. said:
Welcome to the Cove. As usual I think db gave good advice. Do what works for you and your employees and what makes sense. Involve the users of the documents.

As to needing to control the recording forms, that depends on what you mean by that, IMO. The completed forms/data needs to be kept as a quality record based on what you say you will do to comply with 4.2.4, however, the blank forms themselves do not need to be controlled unless they contain instructions. If the blank form is just an organized place to write data it does not require formal control IMO. I would definitely control testing /inspection procedures.

Hope this helps.
Click to expand...
Mike,

Thanks for the info. I thought I had to control the blank forms. If I reference the form to record the data/information to in my WI which I think will be related to my QAP, can I still not control the form ?

Another question, does the form become a controlled document after it has information/ data recorded on it ?

Thx

John
 
M

Mike S.

Happy to be Alive
Trusted Information Resource
#7
#7
woodsjo said:
Mike,

Thanks for the info. I thought I had to control the blank forms. If I reference the form to record the data/information to in my WI which I think will be related to my QAP, can I still not control the form ?

Another question, does the form become a controlled document after it has information/ data recorded on it ?

Thx

John
Click to expand...
John,

As to your first question, again, I do not feel you need to control ANY blank form unless you say somewhere that you are going to do it or unless it contains instructions (in which case it is not just a form but a WI as well). ISO does not say you must control blank forms. In my WI's where I reference a form I might say something like "...record the data on form XYZ or equivalent" or "...use of a preprinted form similar to Form XYZ is permitted for ease of data recording". This way, the user is reminded that a form exists, which may ease recording duties or make things look nicer, but if you run out of forms or want to change the form to add some lines or something there is no hassle associated. KISS principle.

After you record data on the form it is no longer a form, it is a quality record. YOU decide based on 4.2.4 which quality records you will keep, where you'll keep them, who will keep them, for how long, etc.

Hope this makes sense. If not write back.
 
G

Greg B

#8
#8
I'll have a stab at this

woodsjo said:
Dave

I think what I am trying to accomplish is to relate the WI's to the QAP. I then think that I am trying to relate the test/inspection procedure to the WI. I am then trying to relate what form I need to use to record the data after my inspection/test procedure has been completed and document the required information(this would complete my QMS pyramid). Does this approach make sense ? How do I control the test / inspection procedure if it is a std industry test ? Is there a different way I should be reviewing ?

Thanks for your reply

John
Click to expand...
John,

IMHO, I think the Overall Inpsection Procedure should be referenced in the QM (8.2.4 / 8.4 at least). I like to reference down rather than up ie: QM to QSP to WI to Form. In my Work Instructions I reference all of the forms that are required to complete the task. In my QSPs I list all of the Work Isntructions required to perform the Process. In my QM I have a list of all of the Procedures.
I don't include 'details' in my QMS that should be common knowledge or are part of a skills set etc. I don't tell chemists how to be chemists or electricians how to be electricians.

BTW, I have all of my forms registerd (150) in the QA system. I don't want someone forgetting to take down and record the correct details or changing the forms illegally so someone else forgets. If the data is required then it better be in the system (IMO). This is probably as clear as mud but I hope I helped. :p

Greg B
 
V

Valeri

#9
#9
woodsjo said:
Mike,

Thanks for the info. I thought I had to control the blank forms. If I reference the form to record the data/information to in my WI which I think will be related to my QAP, can I still not control the form ?

Another question, does the form become a controlled document after it has information/ data recorded on it ?

Thx

John
Click to expand...
I agree with Greg. I have been in Quality Systems for 10 years and have always controlled forms as long as they will be used as a quality record.

Let's take an example: you have a form being used to record the measurements of a part which makes it a quality record. Your customer is having a problem with dimension X and mandates (on a certain date) measurement of that dimension and the form is changed to reflect the mandate. However, the measurement is not being made because old copies of the old form are being used (these have been squirreled away to save steps to the copy machine). Not only is the measurement not being made, there is also no evidence to provide the customer that the change was made on the date it was requested.

The easiest way to control a form that will be used as a quality record is to put the implementation date in the footer. We control all forms electronically in a "shared" folder with read only access to all personnel - only the QS coordinator has the electronic authorization to make changes documents within that folder.
 
M

Mike S.

Happy to be Alive
Trusted Information Resource
#10
#10
Valeri said:
Let's take an example: you have a form being used to record the measurements of a part which makes it a quality record. Your customer is having a problem with dimension X and mandates (on a certain date) measurement of that dimension and the form is changed to reflect the mandate. However, the measurement is not being made because old copies of the old form are being used (these have been squirreled away to save steps to the copy machine). Not only is the measurement not being made, there is also no evidence to provide the customer that the change was made on the date it was requested.

The easiest way to control a form that will be used as a quality record is to put the implementation date in the footer. We control all forms electronically in a "shared" folder with read only access to all personnel - only the QS coordinator has the electronic authorization to make changes documents within that folder.
Click to expand...
If the customer mandated the measurement of a certain dimension, and the only place this mandate is reflected is the form, then IMO you SHOULD control the form because, as I mentioned in my earlier posts, the form is then acting as a WI. But if this customer mandate (spec.) was added to the WI (via a WI revision) the data could be recorded on a blank piece of paper instead of the form with no harm done, thus the form would not need to be controlled or needed at all.

Greg says "I don't want someone forgetting to take down and record the correct details or changing the forms illegally so someone else forgets." Again, if the form is required to tell someone what to do it is more than a form and should be controlled. But if the WI covers what to record (in total) then the data can be recorded on a form or a blank piece of paper. I make some measurements for which I have uncontrolled forms. The WI tells me all that needs to be recorded, and of course I've done it so often I know the WI by heart anyway. If I run out of forms I can record the data on a blank piece of paper if I want (and I have). If I decide I want to change the form a bit to, say, give me more room to write, or allow me to record more data on one piece of paper, etc. I can revise it at will and do not need to do any formal revision tracking, etc.

I'm NOT saying that controlling forms is necessarily WRONG, just that it is NOT REQUIRED by ISO 9K2K or ISO 9K-1994. Do what works best for you, but, as Marc says, one size does not fit all.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T One Work Instruction instead of Many - Reducing Documentation Document Control Systems, Procedures, Forms and Templates 7
J Is there any Work Instruction documentation template that I can refer? Document Control Systems, Procedures, Forms and Templates 1
D Swiss Documentation Requirements for Class 1 Medical Device Other Medical Device Related Standards 0
M Should DoC be updated every time Technical Documentation is revised? EU Medical Device Regulations 2
P Controls over Systems Documentation in 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 1
D Does the DoC require a technical documentation version? ISO 13485:2016 - Medical Device Quality Management Systems 1
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
P AS9100D clause 8.6 - Documentation required to show evidence of conformity AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
E Discussion: How do you split up your Technical Documentation? EU Medical Device Regulations 4
B Technical Documentation for a medical device accessory Medical Device and FDA Regulations and Standards News 6
I Request for information regarding remote medical monitoring software (its technical documentation and the IUD system) IEC 62304 - Medical Device Software Life Cycle Processes 2
G Technical documentation for UKCA UK Medical Device Regulations 4
xfngrs Multi-lingual documentation IATF 16949 - Automotive Quality Systems Standard 6
R Configuration Management - Identifying Documentation IEC 62304 - Medical Device Software Life Cycle Processes 3
A Technical Documentation => Responsibilities when signing documents ISO 13485:2016 - Medical Device Quality Management Systems 7
A Update of Technical Documentation EU Medical Device Regulations 3
C FDA 510k documentation requirements US Food and Drug Administration (FDA) 1
M Documentation accompanying an aerospace part AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
G Seeking reference guides/ documentation /tips on verification best practices Other Medical Device Related Standards 6
P MDR documentation submissions EU Medical Device Regulations 4
dubrizo Good Documentation Practice (GDP) as it Applies to External Contractors or Vendors Document Control Systems, Procedures, Forms and Templates 4
A Updating Technical Documentation regularly => Leaner Release Advice EU Medical Device Regulations 2
P Updates to Technical Documentation EU Medical Device Regulations 7
R Good Documentation practices SOP US Food and Drug Administration (FDA) 2
S Documents belonging to Technical documentation to be stored in one file or spread in the QM system? EU Medical Device Regulations 9
O MDD 93/42 and making documentation available EU Medical Device Regulations 1
J Advice on documentation for project I am working on... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
H Characteristics related to safety - format of documentation ISO 14971 - Medical Device Risk Management 3
H Do you repeat information throughout your documentation submission? EU Medical Device Regulations 4
J How many hours for a NB to review Technical Documentation? EU Medical Device Regulations 6
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
A Technical documentation ce marking pippete tips CE Marking (Conformité Européene) / CB Scheme 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
I "Usability" for technical documentation EU Medical Device Regulations 1
Azaarus Help with CAPA for an IATF finding regarding inspection documentation IATF 16949 - Automotive Quality Systems Standard 10
E Technical documentation for IVDD General/ other CE Marking (Conformité Européene) / CB Scheme 3
B ISO13485 Standard Documentation Packages ISO 13485:2016 - Medical Device Quality Management Systems 2
C Requirement for Revision of Standard in all Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Z Data sheet from McMasterCarr enough for RoHS/REACH documentation? REACH and RoHS Conversations 4
K Addressing Missing Documentation Document Control Systems, Procedures, Forms and Templates 7
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
NDesouza COTS Items CoC for FAI Documentation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 2
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
C Documentation hold during submissions? ISO 13485:2016 - Medical Device Quality Management Systems 0

Similar threads

Top Bottom