SBS - The best value in QMS software

How many Quality Manuals does your company have?

MichelleD

Involved In Discussions
#21
Only one documented Quality Management System should exist. Multiple manuals by department will fail to improve the business. Those that placed this task before should respect you when you tell them that only one documented QMS will work. If you receive continued resistance, a strong internal audit of the system that uncovers problems with compliance to the standard should help others see your point of view.

Pat Ryan
Thanks...I'm actually working on that right now. I'm in the process of retraining our internal ISO Agents. Before I came on board, they had a trainer/consultant come in to do training but all of them say they would be uncomfortable out on their own performing an audit to a standard they don't understand. Lucky for me, they all are eager to learn what a really effective audit can offer the departments and the company.
 
Elsmar Forum Sponsor
O

osospat

#22
We have only one documented Quailty System. It it accessible through an electronic master found on our internal server which is networked throughout the facility. We maintain the maintain the master copy electronically on this server. We recently transitioned from paper copies located throughout the facility to the current arrangement. It is easier for us to update and maintain, but there is a learning curve of getting people in the habit of accessing them on a computer instead of reaching for a dusty old paper copy version.
 
R

Roto_Manic

#23
We actually have (2) Quality Manuals here. We have one from Corporate Headquarters and then one for the plant itself. What really gets me is, we are not an actual plant unto ourselves, but rather a department of a plant that is 50 minutes away. Although we both use the same "plant QM", we start seperating QSP's. The main plant uses QSP's for each department, and those QSP's are mainted by the department, while our QSP's are mainted by QA. At times, as seen recently :frust:, this can be a headache during an audit, whether external or internal. The best scenario, IMHO, would be to have one Quality Manual and one set of QSP's maintained by DC.
 

MichelleD

Involved In Discussions
#24
We actually have (2) Quality Manuals here. We have one from Corporate Headquarters and then one for the plant itself. What really gets me is, we are not an actual plant unto ourselves, but rather a department of a plant that is 50 minutes away. Although we both use the same "plant QM", we start seperating QSP's. The main plant uses QSP's for each department, and those QSP's are mainted by the department, while our QSP's are mainted by QA. At times, as seen recently :frust:, this can be a headache during an audit, whether external or internal. The best scenario, IMHO, would be to have one Quality Manual and one set of QSP's maintained by DC.

Our procedures are also kept by each department. The problem is that no one seems to keep them in the same formate and it is extremely confusing when the operators try to find their procedures. I've read over the last few audit reports and this was mentioned in every one of them. I'm definitely going with one Quality Manual. We also have different internal auditor, corrective action and management review procedures for each department which I will be changing shortly. :)
 

CHRSCLLNGS

Involved In Discussions
#25
Hi Michelle,
the company that I worked at before this one sounds very similar, when I started, there was 24 copies of the Quality Manual and Quality Procedures (separate folders) scattered around the office and shopfloor. Every department had it's own copy. I had 3 copies on my desk! (one was a Master, one was the Quality copy and one was the Auditir copy?!?!) I spoke to our auditor and asked if there was any reason why we had so many copies. He wasn't sure either - so I spent a day getting rather close to the shredder. Kept it at 3 copies (Me, MD and OM)
Having lots of copies was ok untill I came to change something, which meant that I had to collect 24 box files, un-bind them (comb bound) change 2 or 3 pages, re-bind them and distribute them, making sure everyone knew what had changed. It was a serious pain in the a$$
Chris
 

gard2372

Quite Involved in Discussions
#26
Ah, It's so nice to hear the same questions coming from someone else that I've been asking around here. And maybe "the masses" was the wrong phrase. I hear "grumble grumble" which is about what it amounts to. Not enough time, waste of time, etc. You name it - I've heard it. "We are not going to keep our certification, what does it matter?" :mad:

Luckily (or maybe unlucky) I've been given the authority to lead the effort to overhaul of the system. The major problem is that every department has their own mini system set up and managers/supervisors do not want anyone to mess with it. But if you talk to the operators of those same areas, they are drowning and are ready for someone to throw out a life preserver.

I am trying to get the point across to them that whether we are ISO certified or not we still must have a good business management system in place. The feeling here is to replace ISO with Six Sigma. They don't understand that these are two completely different systems that do different things for the business. And I know I'm rambling but talking this out is helping me make sense of it so I appreciate everyone listening.:thanx:


Michelle,

Is your management team insane? They, the "proverbial they" are thinking about being after reading your posts IMHO Not nearly compliant to ISO and instead are thinking about 6S? If they can't invest in the small amout of manily time (yours) and personnel resources to bring the QMS up to par then why would they want to bring in consultatns or spend thousands of dollars training and trying to implement the flavor of the month? :bonk:

I think you're on the right track in the direction you're taking but it seems to me management is looking at the attractiveness of usings 6 sigma as a cost savings tool and enterprise improvement. This does have underlying showings that top management does at some level within their being want quality improvement so you have some clay to model a masterpiece with there.

Now if they'll only provide you with the tools and environment? :magic:
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#27
Thanks....This is exactly the way I want to head and how I've set my other systems up in the past. I was just curious as to if anyone has had this work for them. I've only been here three weeks and still try to get a good handle on the "whys". I think I saw a quote on here the other day about "how do you eat an elephant" and the answer is one bite at a time. I have a feeling my biggest hurdle will be top management buy-in.
fortunately in my case senior management realized the need to straighten this out - it's why they hired me.

How did I do it?
in a nutshell:
1) Wrote new document control procedure
2) Formed a Document Control Team to help transition
3) All new documents went into this new system as of a cut off date
4) Started converting old procedures to the new system and taking them out of the old "quality manuals"
5) Document Control Team became ISO9001 Implementation Team
6) Once the old quality manuals were down to bare bones I wrote the new quality manual and had it approved.
7) obsoleted the old quality manual.

Sprinkle in liberal amounts of company wide training and communication via charts and graphs on the employee bulletin board across all steps.

hmmm... I wonder if I can turn this into a 12 step program for QMS reform....
;)
 
A

arin_23

#28
Hi All,

I've just started with a new company and I have found out that all the departments have their own Quality Manual. I've worked at several companies but all have had just one Quality Manual that governed the ISO system.

Please let me know if you've seen this work other places or is one Quality Manual all you should have. I'm leaning toward only one but getting some resistance from the masses. :frust:

Thanks for any help you might offer. :)

Michelle
Hi Michelle,

Is your organization having multiple sites having muliple type of functionalities? In my organization we have got rid off the hard copies of manual.

We have created an apex manual and six mandatory procedures, we have also created a common server space where the apex manual and the mandatory procedures are kept along with the quality policy, mission-vision statements, organizational chart and responsibility& authority matrix. The Acess privilage (read only) is given to all of the departments.

However there are separate process manuals, departmental objectives , documents and records for individual departments. These documents and records are individually manitained by the departments.

we have also clearely defined the clause exclusions department wise in the apex manual so as to enable the auditors understand the departmental activities in detail.

To promote the quality policy, it is requested to all the departments to put the quality policy statement as their desktop background and it really worked well.

Cheers:cool:

Arindam
 

MichelleD

Involved In Discussions
#29
Hi Michelle,

Is your organization having multiple sites having muliple type of functionalities? In my organization we have got rid off the hard copies of manual.


Arindam

No, we are at one site. We are the corporate customer service/repair center for the company. Each department (at the same site) has their own Quality Manual. And it's not working very well. Like I was saying in an earlier post, the more I dig I realize they all have their own mini ISO systems set up. Very odd. :confused: I'm working on a system to get rid of all the hard copies. As of right now, I am the documentation department, too. All the original copies are in three binders all over my desk. This will have to be changed. We have the technology...we're just not using it (yet).
 
A

asdf12345

#30
Hi All,

I've just started with a new company and I have found out that all the departments have their own Quality Manual. I've worked at several companies but all have had just one Quality Manual that governed the ISO system.

Please let me know if you've seen this work other places or is one Quality Manual all you should have. I'm leaning toward only one but getting some resistance from the masses. :frust:

Thanks for any help you might offer. :)

Michelle
I think your problem led by bad combination. I meet similar situation. Our company is a manufactory of an international company. We have many divisions, and these divisions come from different countrys. They own different culture and system. So the combination is very very important and difficult.
 
Thread starter Similar threads Forum Replies Date
S How many times do you have the term 'Requirements' in your Quality Manual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
V How many times the quality agreement has been invoked? ISO 13485:2016 - Medical Device Quality Management Systems 3
A How many processes for an FDA Quality System (QSR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
J How many Quality Objectives should a company have ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Colin How many Quality Objectives do you have? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
T Cost of Quality - How many variations are there in calculating the Cost of Quality? Misc. Quality Assurance and Business Systems Related Topics 4
C Why Are There So Many Quality Standards? Misc. Quality Assurance and Business Systems Related Topics 17
P How many people are involved in Quality in the Water and Wastewater Sector Career and Occupation Discussions 3
Q How many sentences does your Quality Policy statement contain? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 119
T Number of Quality Personnel - How many quality personnel does your company employ? Misc. Quality Assurance and Business Systems Related Topics 18
E Need an ISO 9001/14001/13485 Quality Manual - Many suppliers - Pharma and Med Devices Quality Management System (QMS) Manuals 7
R 'Quality Month' - Why is November chosen in many countries? Any significance? Philosophy, Gurus, Innovation and Evolution 11
G Inspectors in a furniture manufacturer - How many quality assurance auditors Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
A How many words can be made out of "QUALITY CONTROL"? Coffee Break and Water Cooler Discussions 8
S How many Cost of Quality addressed in ISO 9004? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K ISO 17025 Quality Manual and 58 page Checklist - And how many procedures do I need? ISO 17025 related Discussions 5
B How many nonconformances have you received on average during IATF audits? General Auditing Discussions 24
G Too many customer complaints Customer Complaints 16
I How many gauges in a Go/No Go Gauge? General Measurement Device and Calibration Topics 7
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
Watchcat How Many Notified Bodies are "Enough" Already? EU Medical Device Regulations 23
S How many mandays required for the below mentioned standards IEC 27001 - Information Security Management Systems (ISMS) 3
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
F How many signatures do we need on calibration certificates? ISO 17025 related Discussions 8
M Informational From RAPS – Operating System Vulnerabilities in Many Medical Devices, Germany’s BfArM and Device Firms Warn Medical Device and FDA Regulations and Standards News 0
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
K How Many Samples to send for Chemistry Testing Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
N MDSAP Participants 2019 - How many companies are participating YTD? ISO 13485:2016 - Medical Device Quality Management Systems 20
S How many of you are using Robotic process automation for calibration lab management? ISO 17025 related Discussions 0
G Measuring customer parts on a CMM - How many decimals to report to the customer? ISO 17025 related Discussions 28
J Supplier choice limitation - Many of them dont have PSCR, VDA or even ISO 9001 VDA Standards - Germany's Automotive Standards 0
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
G How many samples you require to test during PQ for validation of a equipment? ISO 13485:2016 - Medical Device Quality Management Systems 1
D IATF 16949: Do we have too many processes? Are they all the same? Registrars and Notified Bodies 7
D QMS Performance Based on how many NCRs were generated month to month Nonconformance and Corrective Action 8
S How many QMS processes and procedures? ISO 13485:2016 - Medical Device Quality Management Systems 2
L How many of you are Certified to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 12
G How many Uncertainty Measurements for Micrometers and Calipers? Measurement Uncertainty (MU) 3
R How many Corrective Action Request can be Issued by DCMA for a single issue? Nonconformance and Corrective Action 2
A Training Program Help - Old docs, new docs, so many docs... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M How many Pieces to Test - Sterility Testing USP EU Medical Device Regulations 2
P Are we an outlier for so many variations of Change Management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M SPC with many data points from one dimension Statistical Analysis Tools, Techniques and SPC 16
L How many working hours to required to implement ISO 14001 ? ISO 14001:2015 Specific Discussions 6
B ISO/TS16949 Internal Auditing - How many auditors? Internal Auditing 4
R Training Production Employees When We Have SOOO Many SOPs Training - Internal, External, Online and Distance Learning 9
P Scope Extension Audit - How many days? Do I audit all AS9100 requirements? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J How can I manage Occurence Rates in FMEA efficiently when I have many processes? FMEA and Control Plans 9
C How to document many document control systems with one Document Control Procedure? Document Control Systems, Procedures, Forms and Templates 6
A How many laboratories are accredited to ISO 17025 in the USA? ISO 17025 related Discussions 5

Similar threads

Top Bottom