Quality checklist for opening a second location

mgoodman08

Starting to get Involved
#1
Hi everyone,

Was wondering if anyone had any type of quality checklist for opening a second location? A little background - We are ISO 13485 Medical Device company and we are opening a second manufacturing location. Basically just moving all our current Milling equipment to the second location.
Thanks!
 
Elsmar Forum Sponsor

JoshuaFroud

Involved In Discussions
#3
I unfortunatly dont have a checklist I can share however, the hivemind here may well be able to make some useful suggetions of things to check/do/review to that ends a little more background may help,

Are you looking to open a second site and close the first or continue to run two locations?
Will both locations be doing the same thing?
What will be the physical seperation between the sites?
Do you plan on running the same QMS across both sites or will you be starting again?

Let us know and hopefully someone can help.
 

mgoodman08

Starting to get Involved
#4
We'll be running both locations and both locations will be doing the same things. One location in FL and one in CT. I plan on running the same QMS across both sites.
 

indubioush

Quite Involved in Discussions
#5
You should have a quality plan that outlines everything you will need to do to qualify the new facility. You should document the requirements for infrastructure, utilities, location of different manufacturing areas, and plan for process validation if you are duplicating processes that are already validated. Your plan should also state any changes needed to the quality system. As you execute your plan, you will have records that will become part of the facility qualification report. Hope that helps.
 

indubioush

Quite Involved in Discussions
#6
Also know that you will have to notify your customers that their products may be produced at a different location. Many of your customers will want to audit the new facility.
 
Thread starter Similar threads Forum Replies Date
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
M Layered Audit Checklist with focus on daily quality General Auditing Discussions 3
A Quality Assurance System Evaluation Checklist for AAR M-1003 Other ISO and International Standards and European Regulations 14
A Checklist for Auditing the Quality Dept. (I need your comments) Internal Auditing 14
D Looking for an example quality checklist for a footwear manufacturing site Document Control Systems, Procedures, Forms and Templates 1
M GM's QSB (Quality System Basics) - Checklist for Control Plan Audit development. FMEA and Control Plans 4
A Is an Internal Quality Audit Checklist necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P Printing Industry Quality Control Traveler / Checklist needed Manufacturing and Related Processes 2
P Printing Company - Internal Quality Checklist for each process Manufacturing and Related Processes 6
Ajit Basrur Quality Manual and Audit Checklist for ISO 17025 ISO 17025 related Discussions 1
K Quality Management System (QMS) audit checklist needed General Auditing Discussions 3
A ISO/TS16949 Quality Systems Assessment Checklist is being retired as of 1 June 2004 IATF 16949 - Automotive Quality Systems Standard 1
K ISO 17025 Quality Manual and 58 page Checklist - And how many procedures do I need? ISO 17025 related Discussions 5
N Guidance - Cost of Good Quality Misc. Quality Assurance and Business Systems Related Topics 2
D Quality plan for moving locations ISO 13485:2016 - Medical Device Quality Management Systems 3
was named killer Job Opportunity-Quality Engineer-Tampa Florida Job Openings, Consulting and Employment Opportunities 0
Marc Job Opportunity – Quality Assurance Specialist - Suspense 7 April 2021 Job Openings, Consulting and Employment Opportunities 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
normhowe "The Problem with Quality Management: Process orientation, controllability and zero-defect processes as modern myths" Book, Video, Blog and Web Site Reviews and Recommendations 2
J Quality Objective for QMS prior to Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J Quality Objectives and resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 2
A Quality Control Datasheets Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
T Quality auditor legal right to see Board meeting minutes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D Any recommendations on where to find experienced quality hires in Chicago area? Job Openings, Consulting and Employment Opportunities 3
C Budgetary cost to obtain ASME NQA-1 Quality Program Certification Quality Management System (QMS) Manuals 0
O Soft and technical skills for a VP of Quality Career and Occupation Discussions 1
P MedWatch Report from a hospital due to a quality issue US Food and Drug Administration (FDA) 5
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
M Unique Quality Management System for 2 sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Application to Chartered Quality Institute - MCQI ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
K Quality Agreement MDR - The manufacturer is outside of EU Other Medical Device Related Standards 4
Sidney Vianna Informational APQP4Wind - Advanced Product Quality Planning for the Wind Power Supply Chain APQP and PPAP 3
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Supplier protocol for the Quality Supplier Quality Assurance and other Supplier Issues 6
bruceian Software Quality Metrics Software Quality Assurance 11
Bev D Essential References for Practical Quality Engineering Misc. Quality Assurance and Business Systems Related Topics 0
optomist1 Automotive News The Cost of Inspecting In Quality IATF 16949 - Automotive Quality Systems Standard 7
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
John Broomfield CIOB - Code of Quality Management Misc. Quality Assurance and Business Systems Related Topics 1
S Quality Audit Training Activities Quality Manager and Management Related Issues 2
D Are Supplier Quality Agreements Quality Records ? Other Medical Device Regulations World-Wide 9
D Big companies suffer from quality management system? ISO 13485:2016 - Medical Device Quality Management Systems 1
K Looking for a job as Quality Engineer Career and Occupation Discussions 2
B Two excellent examples of process capability analysis from Quality Magazine Capability, Accuracy and Stability - Processes, Machines, etc. 5
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
NDesouza No Quality Professional vs Having a Quality Professional Benchmarking 24
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
R Monitor production quality - Internal KPIs Manufacturing and Related Processes 5

Similar threads

Top Bottom