S
SubSeaQC
Greetings!
Many thanks to all in advance as I've been using this site for some excellent reference material.
Brief History:
Small oil and gas industry design/manufacturing firm with ~30 employees that is growing exponetially (+20% year 1-2, +300% year 2-3, forecast is +400% for 3-4 with us refusing work). I was brought on board in July of last year to compose and implement a quality program. After reviewing the business processes, I composed a "cookie cutter" ISO 9001:2008 program to have "something". I then began work on a detailed process based program. In Nov of 2011, we underwent a comprehensive audit by a potential client during which we committed to ISO certification (the previous goal was to be "compliant, yet not undergo the formal auditing".
Question 1: During the process based QMS program composition, I discovered many shortcomings as there was no process in place. Should I document these as corrective actions to present to the ISO registrar?
We did receive positive feedback from our customer audit team which provided the additional "enforcement" that I needed to get this program completed and implemented. There really isn't resistence at all to the processes as the department leads are fully integrated into the process definitions. Once the processes were complete, I held a formal "introduction to QMS" meeting with each process group. I am currently finishing up our first "formal internal audit".
Audit Results:
Control of records/documents - we are not 100% there as the electronic document control software is being integrated. Are the QMS documents controlled? Absolutely.
NCR's- Once explained, we are now starting to document our issues rather than simply fixing them and moving forward.
CAR/PAR- Processes are defined, few records at the moment.
We have identified our registrar of choice based on industry recognition. They are most certainly going to take their sweet time. I've opted for a pre-audit gap analysis in efforts to gain some additional insight in the event that I've greatly missed anything or interpreted the ISO specification incorrectly.
Question 2: Audit schedule. Is this simply a chart which shows which portions of the QMS are to be audited and when?
Question 3: What is the formal name to the document created to audit against? (I.e. the list of questions)
Process overview:
Contract Review
Design/Engineering
Purchasing
Manufacturing (we do not manufacture anything in house)
Receiving/Assembly/Test (we do however assemble and perform factory acceptance testing/certification of all equipment in house)
Quality/Continuous Improvement
I have created process flowcharts for the above showing the workflow and document flow. The meat and potatoes of the QMS manual describes the contents of these diagrams.
Question 4: Is this redundency? My thoughts were that both were needed to show the tie between the flowcharts and the ISO specification sections.
Management Review:
A meeting agenda is prepared to address Quality issues which is presented/discussed weekly at our management meeting. Currently this is to provide an updated to the QMS program implementation status. In addition, a project quality summary report is also presented and discussed in the weekly production meeting. Meeting attendees are nearly the same. Agendas/notes/sign in sheets are stored securely on the shared server. The formal audit report shall command a seperate meeting to allow for documentation of it's occurrence.
What am I missing?
I have a process and applicable forms created with revision #'s and dates, all of which are available as read/print only to all employees. Our design drawings are secured. Our engineering reports are secured. Special processes are defined (welding, coating, forging, etc.) and monitored with submittals, ITPs, internal and external inspectors. All design/engineering "product realization" files are maintained by the lead designer in a "project binder" which is an evergreen document which fulfills our interpretation of the ISO requirements.
I'm either on the boat or ears deep in sharks!
Many thanks in advance!
Robert
Many thanks to all in advance as I've been using this site for some excellent reference material.
Brief History:
Small oil and gas industry design/manufacturing firm with ~30 employees that is growing exponetially (+20% year 1-2, +300% year 2-3, forecast is +400% for 3-4 with us refusing work). I was brought on board in July of last year to compose and implement a quality program. After reviewing the business processes, I composed a "cookie cutter" ISO 9001:2008 program to have "something". I then began work on a detailed process based program. In Nov of 2011, we underwent a comprehensive audit by a potential client during which we committed to ISO certification (the previous goal was to be "compliant, yet not undergo the formal auditing".
Question 1: During the process based QMS program composition, I discovered many shortcomings as there was no process in place. Should I document these as corrective actions to present to the ISO registrar?
We did receive positive feedback from our customer audit team which provided the additional "enforcement" that I needed to get this program completed and implemented. There really isn't resistence at all to the processes as the department leads are fully integrated into the process definitions. Once the processes were complete, I held a formal "introduction to QMS" meeting with each process group. I am currently finishing up our first "formal internal audit".
Audit Results:
Control of records/documents - we are not 100% there as the electronic document control software is being integrated. Are the QMS documents controlled? Absolutely.
NCR's- Once explained, we are now starting to document our issues rather than simply fixing them and moving forward.
CAR/PAR- Processes are defined, few records at the moment.
We have identified our registrar of choice based on industry recognition. They are most certainly going to take their sweet time. I've opted for a pre-audit gap analysis in efforts to gain some additional insight in the event that I've greatly missed anything or interpreted the ISO specification incorrectly.
Question 2: Audit schedule. Is this simply a chart which shows which portions of the QMS are to be audited and when?
Question 3: What is the formal name to the document created to audit against? (I.e. the list of questions)
Process overview:
Contract Review
Design/Engineering
Purchasing
Manufacturing (we do not manufacture anything in house)
Receiving/Assembly/Test (we do however assemble and perform factory acceptance testing/certification of all equipment in house)
Quality/Continuous Improvement
I have created process flowcharts for the above showing the workflow and document flow. The meat and potatoes of the QMS manual describes the contents of these diagrams.
Question 4: Is this redundency? My thoughts were that both were needed to show the tie between the flowcharts and the ISO specification sections.
Management Review:
A meeting agenda is prepared to address Quality issues which is presented/discussed weekly at our management meeting. Currently this is to provide an updated to the QMS program implementation status. In addition, a project quality summary report is also presented and discussed in the weekly production meeting. Meeting attendees are nearly the same. Agendas/notes/sign in sheets are stored securely on the shared server. The formal audit report shall command a seperate meeting to allow for documentation of it's occurrence.
What am I missing?
I have a process and applicable forms created with revision #'s and dates, all of which are available as read/print only to all employees. Our design drawings are secured. Our engineering reports are secured. Special processes are defined (welding, coating, forging, etc.) and monitored with submittals, ITPs, internal and external inspectors. All design/engineering "product realization" files are maintained by the lead designer in a "project binder" which is an evergreen document which fulfills our interpretation of the ISO requirements.
I'm either on the boat or ears deep in sharks!
Many thanks in advance!
Robert