Mixed Use of Corporate and Site Level Procedures and Forms in the Quality System

M

Med Devices

#1
Help! Has anyone else inherited a quality system where procedures and forms that are released at the "corporate" level were utilized, but not released at the site level?

To be very clear, these are two distinct sites, with different products, CE mark certs, and establishment registrations.

The practice of using forms and procedures for convenience / lack of corresponding site level procedure / whatever reason was started some years ago, and there are no site level approvals in the Doc Control system for their use.

Any suggestions on how to unravel this mess???
 
Elsmar Forum Sponsor

qusys

Trusted Information Resource
#2
Help! Has anyone else inherited a quality system where procedures and forms that are released at the "corporate" level were utilized, but not released at the site level?

To be very clear, these are two distinct sites, with different products, CE mark certs, and establishment registrations.

The practice of using forms and procedures for convenience / lack of corresponding site level procedure / whatever reason was started some years ago, and there are no site level approvals in the Doc Control system for their use.

Any suggestions on how to unravel this mess???
According to waht you said, it seems that the pyramid of Documentation control is not so effective. You can have site procedures but they shall be as addendum of Corporate ones or Corporate quality manual, otherwise we are in presence of a clear violation of 4.2.3 clause of ISO 9001.
Local procedures and related forms shall be approved as well and so they shall be controlled.:bigwave:
 
Thread starter Similar threads Forum Replies Date
GURU SDI Rust preventive oil mixed with kerosene Problem Solving, Root Cause Fault and Failure Analysis 2
H Taguchi mixed model DoE [L16 (4^3 2^6): factors interaction and ANOVA calculation Using Minitab Software 3
M Mixed Reality - What kind of possibilities can you imagine? Coffee Break and Water Cooler Discussions 1
G How to create a mixed OAs in Minitab Using Minitab Software 1
D What is your experience with FDA using "mixed load" i EO sterilization Other Medical Device Related Standards 1
C Flow Meter calibration for mixed gases Calibration and Metrology Software and Hardware 1
Q Mixed data collection (SPC) for different mold cavities Statistical Analysis Tools, Techniques and SPC 2
M AQL (Acceptable Quality Level) for Mixed Part Defect IATF 16949 - Automotive Quality Systems Standard 1
D Mixed Level Pull Simulation - Stock Evolution and Machine Load Lean in Manufacturing and Service Industries 3
S Batch Traceability for Bulk Materials which are mixed in the Storage Tank IATF 16949 - Automotive Quality Systems Standard 6
D Mixed Automotive and Non-Automotive Quality Systems IATF 16949 - Automotive Quality Systems Standard 22
J Any MMA (Mixed Martial Arts) fans here? Coffee Break and Water Cooler Discussions 33
K What to do when form numbers get mixed up on your documents.... Document Control Systems, Procedures, Forms and Templates 2
H Medical Devices and Mixed Lots Manufacturing and Related Processes 4
P Mixed Model Assembly Line Control Plans - Many different options that are available FMEA and Control Plans 2
D Mixed Product - Keeping one product from being mixed with similar product Misc. Quality Assurance and Business Systems Related Topics 12
G Use of Supplier's Corrective Action Form vs. Corporate Form Supplier Quality Assurance and other Supplier Issues 4
J Corporate Scheme (CF32) Interface Matrix and the Activity Codes definitions IATF 16949 - Automotive Quality Systems Standard 16
S Advantages and disadvantages on IATF corporate scheme IATF 16949 - Automotive Quality Systems Standard 6
L Have been purchased by a corporate company ISO 13485:2016 - Medical Device Quality Management Systems 7
Ajit Basrur Corporate management standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Advantages of a corporate certification scheme IATF 16949 - Automotive Quality Systems Standard 8
U IT Process is Taken From company and Added to Corporate Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N IATF 16949 - Mandatory Corporate Documents IATF 16949 - Automotive Quality Systems Standard 10
julsbear Corporate Services as Externally Provided Service IATF 16949 - Automotive Quality Systems Standard 1
J What does "Corporate stewardship" mean? IATF 16949 - Automotive Quality Systems Standard 6
S Corporate Quality Manager keeping me out of the Management Review Meeting Management Review Meetings and related Processes 28
sutie What is Ethics Escalation (“Whistle-Blowing”) Policy - Corporate Responsibility IATF 16949 - Automotive Quality Systems Standard 7
L Corporate Manual - Global Multi-Site ISO9001:2015 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Supplier is dictated to us by corporate Supplier Quality Assurance and other Supplier Issues 5
K Gage Calibration - Corporate Scheme IATF 16949 - Automotive Quality Systems Standard 3
RoxaneB Fighting Corporate Memory Loss Training - Internal, External, Online and Distance Learning 7
C ISO9001: Moving from site certification to corporate certification Quality Manager and Management Related Issues 9
G Setting up a corporate umbrella QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Internal Audits of QMS Corporate Basics at the Local Plant Level ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Steps to Preserve ISO 9001 Certification during Corporate Acquisition? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Question on Corporate Audit Scheme IATF 16949 - Automotive Quality Systems Standard 1
D How do I make the Corporate QMS work in the manufacturing setting? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
N Corporate direction - External Auditor Influenced by Corporate Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
J How to calculate Surveillance Audit Days in Corporate Audit Scheme IATF 16949 - Automotive Quality Systems Standard 4
C Audit of the Corporate Audit Program 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q TS 16949 Manufacturing Site uses ISO 9001 Corporate Laboratory IATF 16949 - Automotive Quality Systems Standard 2
Y Can't meet PEAR goals because of Corporate MGMT... Quality Manager and Management Related Issues 10
U Customer Audit Nonconformity on Internal Audit Program done by Corporate QA General Auditing Discussions 19
D Whither Corporate Social Responsibility Imported Legacy Blogs 2
Sidney Vianna Cleaning up the Global Compact: Dealing with Corporate Free Riders Sustainability, Green Initiatives and Ecology 2
Q Management Review Inputs - Production Site under a Corporate Certification Scheme Management Review Meetings and related Processes 9
M Corporate Procedures and their effects on Companies they Own Quality Manager and Management Related Issues 6
B Corporate Goal about ISO 9001 Registrar Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G Corporate Documents cover local facility - How many departments can I exempt? Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom