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

[woodsjo]

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.

 

[db]

Welcome

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.

Frist of all, Welcome to the Cove!!!

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

 

[Mike S.]

I know I need to control the recording forms but do I also need to control the testing /inspection procedure?

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.

 

[db]

...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.

I would agree with that statement.

 

[woodsjo]

Frist of all, Welcome to the Cove!!!

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

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

 

[woodsjo]

I know I need to control the recording forms but do I also need to control the testing /inspection procedure?

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.

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

 

[Mike S.]

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

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.

 

[Greg B]

I'll have a stab at this

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

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.

Greg B

 

[Valeri]

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

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.

 

[Mike S.]

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.

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.