SBS - The best value in QMS software

Existing Toolroom Process Validation - Need to identify clauses addressed.

X

XIO549

#1
Hi.

In your toolrooms, do you have machine operatives 'Sign-off' on a drawing(s) or record to show that they have completed a work instruction to the requirements (Work Instruction) issued?

What clause is this satisfying?

-----------------
I have an old QMS system that was here before I started, and our current model of operators signing on the provided area on a drawing is just not working, and possibly because the way the Drawing shows where their signature goes, is not universal to each type of machine operation, and in a lot of ways doesn't make total sense to All of the operators.

I would like to revise the process, but need to be sure that I am not eliminating a compliance anywhere to the standard.

I was thinking of just having a signature on each drawing issued, and the signature would simply mean " Completed to spec" as opposed to a list of standard meaningless obvious questions.

However, I first need to identify the Clauses that our current process addresses, so I can revise the Quality Manual in compliance. I really need to be sure that I have all angles covered before I propose this change for document revision.

Any help appreciated.

Xio
 
Elsmar Forum Sponsor

qusys

Trusted Information Resource
#2
Re: Existing Toolroom Process Validation / Need to identify clauses addressed.

Hi.

In your toolrooms, do you have machine operatives 'Sign-off' on a drawing(s) or record to show that they have completed a work instruction to the requirements (Work Instruction) issued?

What clause is this satisfying?

-----------------
I have an old QMS system that was here before I started, and our current model of operators signing on the provided area on a drawing is just not working, and possibly because the way the Drawing shows where their signature goes, is not universal to each type of machine operation, and in a lot of ways doesn't make total sense to All of the operators.

I would like to revise the process, but need to be sure that I am not eliminating a compliance anywhere to the standard.

I was thinking of just having a signature on each drawing issued, and the signature would simply mean " Completed to spec" as opposed to a list of standard meaningless obvious questions.

However, I first need to identify the Clauses that our current process addresses, so I can revise the Quality Manual in compliance. I really need to be sure that I have all angles covered before I propose this change for document revision.

Any help appreciated.

Xio
Hi,
It could fall under 7.5.1 or 7.5.2 of ISO 9001, but the standard does not mention any signature. It is up top the organization to set criteria to meet requirements.
Probably a more detailed framework could be useful to better understanding of the issue.
However, I have seen the there is automation to solve the issue you are mentioning by mean of electronic traveller or database for equipment maintanance.
 
X

XIO549

#3
Re: Existing Toolroom Process Validation / Need to identify clauses addressed.

Hi qusys

Thanks for the reply.

Ya, that's part of the question really; I don't see where our Procedure could possibly interpret that an operator should 'Sign-off' on their works.

In 7.5.2, I understand this to govern only "where the resulting output cannot be verified by subsequent monitoring", (ie: like a rocket can only be proved as working when its in Space).... am I wrong?

And, yes, I am in the process of determining a clear framework for what's required. (a) interpretation of what ISO 9001 is asking of us for this process, (b) how the last quality personnel here interpreted it (and created a procedure & record form, and (c) to understand a way of how we can more effectively comply, perhaps adding value and removing stigma of 'Box Ticking' exercises where practical.

Thanks for the reply - hope to hear back soon.

Xio
 
X

XIO549

#4
Hi

New thought on the matter, (remembering that I am evaluating an old procedure in place here, with a view to making things simpler, and adding value to the process).

Looking at 8.2.4, I think that this is the clause that
determined our process for In-process Inspection.

That said,. the requirement is that we shall "Monitor & Measure" the product as being checked "at appropriate stages of the product
realization process" (aka/manufacture). And that said, this clause does
not show a requirement for maintaining a record of this check, just to make sure that its done. The evidence that we provide to show that this is done is surely contained in the Final Inspection Record, no? :eek: (What do you think?)

So, regardless of the number of steps that we take to end up
with a finished product, so long as we
"indicate the person(s) authorising release of product for delivery to the customer" then we are compliant.

If I'm reading this right, we never needed an
In-process Inspection Procedure before at all, but only a
Final Inspection Procedure that ensures that all steps of
the manufacture taken so far are "Monitored & Measured".

I dread to think what I am missing/ not seeing at this moment, ; I Need to step back and take a global view of it, and perhaps address the clauses of the standard again with this in mind, but interested to see what comments are made on this. :eek:

Thanks again.

Xio.
 

qusys

Trusted Information Resource
#5
Hi

New thought on the matter, (remembering that I am evaluating an old procedure in place here, with a view to making things simpler, and adding value to the process).

Looking at 8.2.4, I think that this is the clause that
determined our process for In-process Inspection.

That said,. the requirement is that we shall "Monitor & Measure" the product as being checked "at appropriate stages of the product
realization process" (aka/manufacture). And that said, this clause does
not show a requirement for maintaining a record of this check, just to make sure that its done. The evidence that we provide to show that this is done is surely contained in the Final Inspection Record, no? :eek: (What do you think?)

So, regardless of the number of steps that we take to end up
with a finished product, so long as we
"indicate the person(s) authorising release of product for delivery to the customer" then we are compliant.

If I'm reading this right, we never needed an
In-process Inspection Procedure before at all, but only a
Final Inspection Procedure that ensures that all steps of
the manufacture taken so far are "Monitored & Measured".

I dread to think what I am missing/ not seeing at this moment, ; I Need to step back and take a global view of it, and perhaps address the clauses of the standard again with this in mind, but interested to see what comments are made on this. :eek:

Thanks again.

Xio.
The requirement 8.2.4 states that the evidence of the conformity to the acceptance criteria shall be maintained. So , you can mantain it in whatver shape of record ( electronic, paper etc...):bigwave:
 
A

albridgeuk

#6
Hi Xio

the procedures you list would not be acceptable with the regulators in the pharmaceutical/medical device/biotechnical and aviation industries.
However the cost of conformance in these industries is understood and costed in.
I can't really help you without knowing exactly what standards you are required to comply with. However if you are required to operate in our industry, let me know and I will send you a free issue document that briefly and very practically takes you through the process.

Alex
Validation Online.
 
X

XIO549

#7
Hi Alex.

Thanks for the reply. We are not in medical device manu, more in Product Design, R&D and building prototype tooling for R&D. So no need for 13485. just 9001,

The question is that I am trying to identify where the existing 'Procedure' of having individual machine operators sign off on each small stage of the machining on components, addresses the standard.

When I can confidently identify this in its totality, I would hope to look at stream lining the QMS Procedure for this, without loosing managements monitoring value, and hopefully to gain better moral for staff complying with the standard going forward.

Thanks again.

Xio
 
R

Randy Lefferts

#8
In your toolrooms, do you have machine operatives 'Sign-off' on a drawing(s) or record to show that they have completed a work instruction to the requirements (Work Instruction) issued?

What clause is this satisfying?
Xio
Agree with qusys that it is most likely 7.5.1.
I don't see where our Procedure could possibly interpret that an operator should 'Sign-off' on their works.
Not everything you do is done to satisfy ISO9001. This is most likely just an internal requirement. They may have felt that having someone sign off when a job was completed would result in fewer jobs having missed steps. Just a business practice, not an ISO requirement.

Looking at 8.2.4, I think that this is the clause that
determined our process for In-process Inspection.
Most likely.

That said,. the requirement is that we shall "Monitor & Measure" the product as being checked "at appropriate stages of the product
realization process" (aka/manufacture).
As qusys pointed out, we do need to maintain evidence.

"Evidence of conformity with the acceptance criteria shall be maintained."



It sounds like your
'Sign-off' on a drawing(s) or record to show that they have completed a work instruction to the requirements (Work Instruction) issued
was just an internal requirement that was deemed necessary in order to ensure that the job instructions were completed.
Simply signing off that a job step was completed doesn't necessarily equal meeting ISO requirements. Are you sure this "signature" was your company's method of in process inspection?

I was employed at an aerospace company for a bit and each part produced had a job ticket / traveller that accompanied each part as the part made it's way through the shop. As the part moved through the plant, the ticket was signed/initialed by each person performing the work for the appropriate stage that the product was in. A job may have had 15 different stages before it was complete. 15 sets of initials ultimately made it to the traveller. This was to confirm that the individual process was completed. Within those 15 different "job steps" there may have been 3-5 (or whatever) in process checks that were initialled. However, the traveller itself wasn't the record that was kept as proof of in process inspection, a different record (CMM result) was the proof of the check. The ticket/traveller was just a "check list" of steps to be completed.

All this said, it seems as if your signoff's are just a checklist of job completion, not a "record" of inspection.

Keep in mind that not all procedures are in place to satisfy ISO 9001. Your company has to determine what is appropriate and important for you to be successful. So you will have procedures in place that are meant to satisfy an internal requirement (which typically satisfies a given ISO requirement). Your job signoff list sounds like one of them.
 
Thread starter Similar threads Forum Replies Date
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
N New (Upgraded Technology) vs Existing Equipment - Measurements Shift Design and Development of Products and Processes 4
D Validation of existing equipment - Risk based approach example ISO 13485:2016 - Medical Device Quality Management Systems 3
D Validation of existing equipment - I have been asked to write a quality assessment for equipment ISO 13485:2016 - Medical Device Quality Management Systems 13
D How to create IQ, OQ, PQ protocol for existing equipment Other Medical Device Related Standards 2
shimonv Creating a new commercial product based on a modification to an existing product Other US Medical Device Regulations 4
K Change of Existing Medical Devices and 510(k) US Food and Drug Administration (FDA) 9
F Device Standards - Managing Changes to existing standards that apply to our devices Other Medical Device Related Standards 1
J Implementing EN 62304:2006 on existing and proven medical devices IEC 62304 - Medical Device Software Life Cycle Processes 6
H Classification of a device that uses an existing battery IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C ISO 14001 vs Existing Quality System - How to keep them separate? ISO 14001:2015 Specific Discussions 3
K Addition of a test reader to existing CE marked product. Other ISO and International Standards and European Regulations 2
D Introducing an existing product into automotive context - DFMEA needed? IATF 16949 - Automotive Quality Systems Standard 8
B NEED HSE-MS Gap Analysis between 2 existing Management Systems Occupational Health & Safety Management Standards 0
D How to add AS9145 requirements to my existing AS9100 QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
K 510k "Premarket" Submission for Existing Class II Software Medical Device US Food and Drug Administration (FDA) 3
A How do we implement a Process Approach ISO 13485:2016 - Existing GMP QMS Other ISO and International Standards and European Regulations 2
N Is a new 510K required for change of manufacturing location for an existing device? US Food and Drug Administration (FDA) 1
K APQP requirement when a new print or spec is received from a customer - Existing Part APQP and PPAP 3
V Procedure to change the Company name in existing TS16949-2009 certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Use of a "Priority existing chemical" in medical device in Australia Other Medical Device Regulations World-Wide 1
B Existing reports and altering such reports AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A How best to start revising an existing ISO 9001:2008 system in a company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I Is it acceptable it is to list new products under an existing 510(k)? Other US Medical Device Regulations 14
G New model for existing Class I Device Listing (510K exempt) US Food and Drug Administration (FDA) 8
S Evaluation of our existing Suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Digitising Existing Documents to ensure regulatory compliance Document Control Systems, Procedures, Forms and Templates 6
S Already Existing Customer Open-PO (Purchase Order) Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Temporary Facility Used For Production - Use of existing Third Party Logos ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
alonFAI Update an existing QMS manual or write a new one for AS9100C Certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Regulation Process for Add on Accessory to an Existing Medical Device Other US Medical Device Regulations 1
M QSR - Design Control on Existing Device not Designed following QSR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
H Medical Device Design Control Requirements (820.30) on Existing Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Anyone added I-m to an existing I-s CE Certificate? EU Medical Device Regulations 1
Q Combining existing 510(k)s into a new 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Integrating acquired existing product into Quality Management System Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D AS9100C - New requirements to existing standard? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Understanding adoption of a product to an existing Sterilization Cycle Other US Medical Device Regulations 1
V Improvement Plan for existing QUALITY TEAM Quality Manager and Management Related Issues 6
P Usability Plan for Existing Equipment IEC 62366 - Medical Device Usability Engineering 5
Q Implementing ISO 14001 into an existing ISO/TS 16949 Quality Management System IATF 16949 - Automotive Quality Systems Standard 6
M Reusing existing RUO Software for IVD Development 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
shimonv Deciding When to Submit a 510(k) for a Change to an Existing Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
I Acceptability of Existing Devices complying to IEC 60601-1 2nd Edition after Jun'2012 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
N Company Name Change - Existing Inventory with Old Company Name Other US Medical Device Regulations 9
M Adopting New Sites and Divisions into an existing ISO 9001 Scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A PPAP for carry over (from an existing to a new model) components APQP and PPAP 4

Similar threads

Top Bottom