Setting up a quality department in an Engineering Firm

#1
Hie everyone.
Could you please give me some advice and guidance? I have started a new position with a small engineering firm as quality assurance. The company has just been signed off for Iso 9001 and I’ve have been given the task to set up the quality department. The only things set up are the quality procedures. I have only just started allocating numbers to documents as a way of control. I am new to this and any help will be helpful. Thanks guys
 
Elsmar Forum Sponsor

dsanabria

Quite Involved in Discussions
#2
Hie everyone.
Could you please give me some advice and guidance? I have started a new position with a small engineering firm as quality assurance. The company has just been signed off for Iso 9001 and I’ve have been given the task to set up the quality department. The only things set up are the quality procedures. I have only just started allocating numbers to documents as a way of control. I am new to this and any help will be helpful. Thanks guys
First - learn the ISO processes - lot's of good stuff at the cove. Then sit with management and identify the customers and their needs or requirements, determine management vision and what they are looking for, finally, establish your processes and measure then for indication of effectiveness.

I just gave you six month of information - take one byte at a time...
 
#3
First - learn the ISO processes - lot's of good stuff at the cove. Then sit with management and identify the customers and their needs or requirements, determine management vision and what they are looking for, finally, establish your processes and measure then for indication of effectiveness.

I just gave you six month of information - take one byte at a time...
thank you dsanabria,much appreciated .
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Hie everyone.
Could you please give me some advice and guidance? I have started a new position with a small engineering firm as quality assurance. The company has just been signed off for Iso 9001 and I’ve have been given the task to set up the quality department.
Sorry, but you are about to make a very common mistake: you don’t need a quality department; you need a Quality function. Quality has to be seamlessly embedded in the organization business processes. Quality has to be a shared responsibility and creating a quality department is the beginning of an archaic path that brings more cons than pros. Rethink your strategy and consider implementing a Quality function without a quality department.

Good luck.
 

Golfman25

Trusted Information Resource
#6
Sorry, but you are about to make a very common mistake: you don’t need a quality department; you need a Quality function. Quality has to be seamlessly embedded in the organization business processes. Quality has to be a shared responsibility and creating a quality department is the beginning of an archaic path that brings more cons than pros. Rethink your strategy and consider implementing a Quality function without a quality department.

Good luck.
Words to live by.
 

Pancho

wikineer
Super Moderator
#7
Re: Setting up a quality department in an Engineering Firm.

As usual, Sidney's advice is it. You need to build quality into your processes. This is done with good documented information and continuous improvement.

The Quality function is not inspection. It is not approval. It is not corrections. It is not training (well, maybe a little of that). Once the initial system is in place, the most important task of the quality function (or whatever you call it) should be to make sure that the continuous improvement process works well. This will allow the organization to learn from experience, good or bad.

In your role, try to make sure that your company's personnel

  1. are empowered to improve the system (that means edit its documents)
  2. continuously capture their knowledge (new or old) into the qms
  3. understand the differences between corrections and improvement actions
  4. know how to log-in and work on corrective and other improvement actions. (The system must be easy to use and everyone should participate.)
  5. recognize that problems, 99% of the time, reveal weaknesses in the system, and not in the individuals doing the work.
 

qualprod

Trusted Information Resource
#8
Sidney
Dont you think that is necessary to explain two issues.
For one side, quality term and concept, ok ,it must exist everywhere, in all the people.
On the other hand, what normally companies do ,it is to have a process with people responsible to approve products to client (quality inspectors) they have knowledge to apply criteria to inspect products, also they know about measurement instruments also their control.
You say this practice, is not useful?
Please clear out this point.
 

Eredhel

Quality Manager
#9
Three are so many things that can fall under what you're asking, but here's one example. One of the old ways of thinking is wait until an order is done and then have quality check a random sampling. That unfortunately is trying to work quality into an already finished thing. In-process inspections instead help make adjustments along the way. But there are even shops where the machinist has more responsibility for acceptance along the way than an inspector, I know of a small (but successful) local shop that has no inspectors and no quality department at all.

A lot of it is going to depend on the context of your organization and how top management wants to get it done.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
On the other hand, what normally companies do ,it is to have a process with people responsible to approve products to client (quality inspectors) they have knowledge to apply criteria to inspect products, also they know about measurement instruments also their control.
You say this practice, is not useful?
Firstly, we need to pay attention to the fact that in the case of this specific discussion, the product in question is an engineering design, not the typical piece of hardware that is "inspected" and approved. So, the process of approving a design passes through layers of verification, validation, reviews, etc., which is integral to the actual process of developing a design.

On a broader perspective, product inspection is something that you want to minimize, over time, via robustization of the actual realization processes. You might believe it, or not, but there are progressive organizations that are working very hard to eliminate product inspections from their lines, at the same time they are significantly increasing product performance, reliability and customer satisfaction. For the organizations of the future, inspection will be a thing of the past. :tg:
 
Thread starter Similar threads Forum Replies Date
I Business Plan for Setting Up a Quality Department Quality Manager and Management Related Issues 4
Ashok sunder What are the criteria for setting a target KPI value against a quality objective? Benchmarking 7
K Setting Quality Objectives (for the first time) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
G Setting Up a Basic Quality Lab for a small manufacturing company General Measurement Device and Calibration Topics 2
Q Setting Quality Objectives with a Timeframe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Setting Acceptance Quality Limits (AQL) for New Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
T Guidance - Setting up an integrated quality & environmental management system Career and Occupation Discussions 12
T Setting Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Setting Quality Objectives for Service, Repair and Sales ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Quality Goals and Improvements in a Bioanalytical Laboratory Setting Quality Tools, Improvement and Analysis 1
B Where do policies fit in the setting up of a Quality Management System (QMS)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G Setting up realistic Quality Objectives - Bulk Material Handling Quality Manager and Management Related Issues 4
M Setting Up a Quality Measurement System - Part of a strategic goal to improve quality Document Control Systems, Procedures, Forms and Templates 4
S Criteria for setting a target value against a quality objective/KPI? Benchmarking 6
B Quality Objectives Vs. Quality Policy - Setting Quality Objectives and Goals AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
L Any tips on setting up a Quality Management System for a Commercial Printer? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C What is the right method to set quality goal? Goal Setting 10X (68% improvement) Quality Tools, Improvement and Analysis 0
Q Setting up a Quality system - No medical device experience - Where to start ISO 13485:2016 - Medical Device Quality Management Systems 6
D Top Management Quality Objectives - Setting objectives and Measurable goals ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
I Quality R&D - How to apply quality principles/plans to a strict design R&D setting? Design and Development of Products and Processes 2
N Defining and Setting Quality Objectives for Each Organization Function and Level ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Icy Mountain Quality Objectives Redux - Setting Actual Numbers (Measureables) IATF 16949 - Automotive Quality Systems Standard 15
N Setting AQL (Acceptable Quality Level) on C=Zero inspections AQL - Acceptable Quality Level 16
A Planning of Realization Processes - Setting Quality Objectives - ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S Heat Sealers Upper and lower limit setting during OQ for Heat Sealer Qualification and Validation (including 21 CFR Part 11) 0
Ed Panek GDPR in Urgent Healthcare Setting Other ISO and International Standards and European Regulations 1
M Setting deadlines (ex. 45 days) for Document Registration & Review Cycle Document Control Systems, Procedures, Forms and Templates 3
R ISO 11137 Gamma sterilization validation, dose setting, dose audit Other Medical Device Related Standards 1
M Best Practice for setting tolerances on a Drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
B Software for setting up New Warehouse Manufacturing and Related Processes 0
S Setting up the process - First piece inspections Statistical Analysis Tools, Techniques and SPC 3
A Add-On software for VMC to calculate setting time, Idle Time, OEE etc.. Manufacturing and Related Processes 2
A Setting up an LLC as a Consultant Paid Consulting, Training and Services 27
A Setting initial Expiry Date of an IVD per BS EN 23640:2015 Other Medical Device Related Standards 12
Proud Liberal Setting up Prolink's QC-Gage to a Keyence IM-6225 Vision System Statistical Analysis Tools, Techniques and SPC 2
Hami812 Cpk Setting Tolerance - Cart before the Horse? (Wifi Routers) Capability, Accuracy and Stability - Processes, Machines, etc. 3
K Bioburden 0 cfu for Dose Setting using the VDmax25 Other Medical Device Related Standards 9
A New company, no employees, Setting up a QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F Setting up a new sterilization unit in a new facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C ISO 14001 Recertification without setting Targets ISO 14001:2015 Specific Discussions 3
M Setting up a M1003 QA Program for the AAR Various Other Specifications, Standards, and related Requirements 2
A Setting up a Medical Device Distributor in Malaysia Other Medical Device Regulations World-Wide 16
R Irradiation Sterilization Dose Setting and Dose Audit Flow Charts ISO 13485:2016 - Medical Device Quality Management Systems 0
J Setting Up New QMS - New US Location ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Setting air gauging outside of a part tolerance Capability, Accuracy and Stability - Processes, Machines, etc. 2
S Target Setting - Internal metric(s) to drive Internal Processes Six Sigma 1
S MSA Help or guidelines - Plastics - Setting up an MSA on a multi cavity fixture Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
G Setting up a corporate umbrella QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
W Setting up from scratch - Looking for help (ISO9001 / ISO13485) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F Setting up a New QMS for Certification when ISO 9001 is about to Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23

Similar threads

Top Bottom