Do we need to establish Quality Objectives per department?

Raffy

Quite Involved in Discussions
#1
Hi
I'm currently in the process of documenting some of requirements in ISO9001:2000, Are we going to have an individually Quality Objectives? Do we need to establish Quality Objectives per department? Does it differ with company quality objective? Or the summary of individual quality objective comprises the quality objective of the company? Where can I get a sample copy of a quality objective, in which I can pattern? Is there a site wherein I can surf to find out on this?
Any feedback would be appreciated.
Thanks in advance,
Raffy
 
Elsmar Forum Sponsor

Kevin Mader

One of THE Original Covers!
Leader
Admin
#2
Originally posted by Raffy:

Hi

1) Are we going to have an individually Quality Objectives?
On an associate level, I would suggest not. A System is not a sum of its parts.

2) Do we need to establish Quality Objectives per department?
I would say yes to this, but they should tie into the Quality Policy you have created for your organization.

3) Does it differ with company quality objective?
They are not the same thing, but they are interrelated.

4) Or the summary of individual quality objective comprises the quality objective of the company?
No.

5) Where can I get a sample copy of a quality objective, in which I can pattern?
For this I ask, what is in your Quality Policy? Does it connect (or the same) as the aim of your organization?

6) Is there a site wherein I can surf to find out on this?
You are already here. Many knowledgeable people here willing to contribute to your success.
7) Any feedback would be appreciated.- We hope to receive the same from you.
Regards,

Kevin
 

Raffy

Quite Involved in Discussions
#3
Hi Kevin,
Thanks for the immediate reply.

Quote: I would suggest not. A System is not a sum of its parts.
I thought its like adding each quality objectives, then by extracting some portion for each department and consolidate it into one.

Quote: I would say yes to this, but they should tie into the Quality Policy you have created for your organization.
When we say our quality objective, was it based from a point that it must be attainable?

Quote: For this I ask, what is in your Quality Policy? Does it connect (or the same) as the aim of your organization?
Our quality policy is basically the aim of our organization wherein its states that "is committed to the timely delivery of world-class services to our customers"...providing product of highest value and quality >>> with these do we need to expound it more comprehensive?

Quote: You are already here.
Many knowledgeable people here willing to contribute to your success. - And I thank everybody for contributing to my developments and success.

Thank you very much,
Raffy
[email protected]
 

Kevin Mader

One of THE Original Covers!
Leader
Admin
#4
Hello Raffy,

System components are interrelated. This means doing something to one component will have consequences (positive and negative) with other components. Having an objective of increased quality for the Quality Dept. and reduced piece price for Purchasing might be in conflict, or, harmonious. All objectives must be in harmony with each other as well as being in harmony with your Quality Policy. For a great example of System Thinking, please visit “dWizard’s Liar” established by one of the longtime contributors here at the Cove, Don Winton.

Objectives should be established within the System’s Capability. Statistical Process Control (run charts of processes for instance) can be used to determine the system/process limits. Setting objectives above the limits will undoubtedly cause system failures elsewhere with other components. Establishing Objectives is serious business and requires close attention and great understanding. They must be set within the process capability in order to drive improvement. Gains aren’t necessarily instantaneous. Many of them will take years to get to where you would like to be (i.e. world-class provider). Be patient.

Your Quality Policy looks o.k. to me. It must make sense to your organization as well as the other components in the system (which you also define). The word I like most is ‘value’. The AIM of any system is to create value or wealth for each component (i.e. profit is important to the organization where as it is not for the customer). Value statements included in a Quality Policy to me is imperative.

I hope this helps.

Regards,

Kevin
 

Raffy

Quite Involved in Discussions
#6
Hi Kevin,
Thank you for the information you've shared, it benefit me a lot.
Quote:
"Your Quality Policy looks o.k. to me. It must make sense to your organization as well as the other components in the system (which you also define). The word I like most is ‘value’. The AIM of any system is to create value or wealth for each component (i.e. profit is important to the organization where as it is not for the customer). Value statements included in a Quality Policy to me is imperative."
Thank you for this, I think all we have to do now is to enhance it.
Marc,
I would like to thank you, too for the site you have provided on this forum. It helps.
Again, thanks to both of you.
Best regards,
Raffy
[email protected]
 

Marc

Fully vaccinated are you?
Leader
#7
What the heck is the 'latest' on 'departmental quality' objectives?

This is almost fall of 2004 - What's 'high tech' with respect to department specific quality objectives requirements and expectations?
 
C

C Emmons

#8
We dont have documented indiviual objectives by department, but:

We have 19 facilities and a corporate office. Corporate has set 4 primary objectives for our system as a whole. Each facility is required to go beyond that and identify what is important to their specific operation and track as appropriate.
 
Thread starter Similar threads Forum Replies Date
F FAA Letter of Need to establish Continuing Need Federal Aviation Administration (FAA) Standards and Requirements 1
Q Does a gage used for a visual verification need to be calibrated? Manufacturing and Related Processes 7
B Hi , everyone i need a procedure for validation of design prototype api 6d (valve manufacturing) Oil and Gas Industry Standards and Regulations 1
J Do we need to raise concessions for every noted deviation under AS9100 Manufacturing and Related Processes 3
M Need to set up a "crisis management and business continuity plan" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
R Customer Returns / RMA's & the need for NCR's AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
T Need advice on what inspection equipment to buy. General Measurement Device and Calibration Topics 2
Sam.F Do heat treatment ovens need calibration? General Measurement Device and Calibration Topics 22
T Need 5 why’s help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
H Need guidance on importation of Custom-made devices into Japan Japan Medical Device Regulations 1
T Need help understanding AS6174 clause 3.1.5. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B Spare parts of medical device need CE mark? EU Medical Device Regulations 0
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 20
leftoverture REACH Folks - We Need Common Sense! RoHS, REACH, ELV, IMDS and Restricted Substances 23
B Whose waste carrier licence do I need? ISO 14001:2015 Specific Discussions 8
I I need some fun examples of teaching the 5 Whys Lean in Manufacturing and Service Industries 43
R First Time Managing Calibration and Measurement System. Need Help. General Measurement Device and Calibration Topics 19
M CE marked medical device - do they need UKAS certified calibration provider ISO 17025 related Discussions 4
C I need some clearing on requirements of Asuring the validity of results ISO 17025 related Discussions 2
C Need help in determining applicable clause for an audit finding (based on AS9120B) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Subcontractors Providing Services Under MDD or MDR need ISO 13485 from EU Notified Body? CE Marking (Conformité Européene) / CB Scheme 8
E Need some peer advice Quality Manager and Management Related Issues 18
S Need clarification on UKCA and "Approved Body" UK Medical Device Regulations 7
S What types of changes need to be notified to NBs? Registrars and Notified Bodies 1
B Do I need a Cleanroom to manufacture Medical Devices? ISO 13485:2016 - Medical Device Quality Management Systems 2
J CMO in Canada do they need MDSAP/13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Attempting to Poke Yoke a wire crimping process...need help Design and Development of Products and Processes 3
C I need your help to find the action plan for these quality objectives Misc. Quality Assurance and Business Systems Related Topics 23
ChrisM Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
Steve Prevette I need a template to solve world hunger, a world class Quality Program, and make lots of money Coffee Break and Water Cooler Discussions 5
C Need to understand difference between an actual Calibration vs. a Calibration check General Measurement Device and Calibration Topics 3
S How many tester quantity we need on the line based on the cycle time and peak volume Manufacturing and Related Processes 3
R Need help on calibration result analysis Measurement Uncertainty (MU) 17
M Do i need to have equipment validation if 100% testing is completed? Qualification and Validation (including 21 CFR Part 11) 6
G Need Help with Run @ Rate for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 0
F Need help in IMS management review Management Review Meetings and related Processes 3
S I need help in corrective action plan Nonconformance and Corrective Action 15
A Do clinical performance studies for IVDs need to be conducted in a member state? EU Medical Device Regulations 2
A Do clinical performance studies for IVDs need to be conducted in a member state? CE Marking (Conformité Européene) / CB Scheme 0
D Weird spec sheet - need help Measurement Uncertainty (MU) 3
E Do I need test reports for all standards mentioned in my 510k application? Other Medical Device Related Standards 8
J Japan registration need manual without temperature reading Japan Medical Device Regulations 0
Ashland78 Need IATF 16949 ISO Gap Analysis Excel File Internal Auditing 3
R Need for an Importer outside EU? EU Medical Device Regulations 0
T Do I need to add non-product related service providers to my ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
K Need Help With Auditing Suppliers Against ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 52
A Need career advice on QMS & HSE (No hands on experience) Career and Occupation Discussions 6
B Need assistance with documents CE Marking (Conformité Européene) / CB Scheme 2
R Lead auditor scenario (Need help) is this non conforming to ISO13485 Manufacturing and Related Processes 2

Similar threads

Top Bottom