Which department should prepare the control plan? could you show me a standard regarding to this matter.

Download Free White Paper
Elsmar Forum Sponsor
J

Johnny Quality

Quite Involved in Discussions
#2
#2
Whoever's got the competent staff to prepare them. In my organization the control plans are prepared by the project engineer, then once approved it is managed by production quality engineers.
 
Jim Wynne

Jim Wynne

Leader
Admin
#3
#3
I agree with @Johnny Quality. Sometimes it's QA, sometimes Engineering, and other times, depending on the size of the company, it could be a person who's wearing several hats. There is no standard.
 
Miner

Miner

Forum Moderator
Leader
Admin
#5
#5
Howard Atkins said:
The standard requires a cross functional team
Click to expand...
By "The standard" do you mean the AIAG Advanced Product Quality Planning and Control Plan manual? If so, it doesn't word it as a requirement so much as a general practice. From page 35: "A multi-disciplined team is established to develop the control plan..." There is no "shall" or "should" wording.
 
W

Wayne Henry

Registered
#6
#6
At my current company (automotive stamping) quality department does the generation of : PFD, PFMEA & PCP (Competency as mentioned by Jonny)
My previous company (window regulator) the manufacturing is responsible for creating and maintaining (living document) of the PFD & PFMEA. While the quality engineer is responsible for using the PFD, PFMEA to create and maintain the Pre Launch & Production control plan.
 
Howard Atkins

Howard Atkins

Forum Administrator
Leader
Admin
#7
#7
IATF 16949
8.3.2.1 Design and development planning - supplemental
The organization shall ensure that design and development planning includes all affected stakeholders within the organization and, as appropriate, its supply chain. Examples of areas for using such a multidisciplinary approach include but are not limited to the following:
a) project management (for example, APQP or VDA-RGA);
b) product and manufacturing process design activities (for example, DFM and DFA), such as consideration of the use of alternative designs and manufacturing processes;
c) development and review of product design risk analysis (FMEAs), including actions to reduce potential risks;
d) development and review of manufacturing process risk analysis (for example, FMEAs, process flows, control plans, and standard work instructions).
 
S

sezgin

Registered
#8
#8
Actually I want to say that, which department responsible to prepare control plan sheets? I know this job requires multi-discipline. for example, the customer wants to engineering changes on the part. we have to revise FMEA and control plan, which department should make it to revise?
 
Howard Atkins

Howard Atkins

Forum Administrator
Leader
Admin
#9
#9
Any that you want.
The biggest problem is that the coordination is always insufficient. Changes do not get reflected.
Use your own judgement and organisation, no one can tell you how to define your own process.
 
S

sezgin

Registered
#10
#10
If quality department prepare control plan, which department will approve. quality prepare control plan and control whole process according to control plan (aaccording to her own control plan)
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
G Should the Quality Department originate a Request for Deviation to the Customer? Nonconformance and Corrective Action 3
L Supplier Approval Process – Should the Quality Department be Excluded? Misc. Quality Assurance and Business Systems Related Topics 7
M Should the Quality Department be independent of Operations Misc. Quality Assurance and Business Systems Related Topics 15
Sidney Vianna Can (and should) you do ISO 9001 in a single department/area? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 35
M Should QA (Quality Assurance) be its own independent Department? Quality Manager and Management Related Issues 33
D Should I put Warehouse under Manufacturing Department? Misc. Quality Assurance and Business Systems Related Topics 8
C Aftermarket Department - Should I add into the Management Procedure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L ISO 9001, 14001, 45001 Audit Questions for a Security & Corporate Affairs Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T QMS Compliance Department KPIs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
K Size of Quality Department ISO 13485:2016 - Medical Device Quality Management Systems 11
bobdoering Is your quality department having a "No Chili" day? Funny Stuff - Jokes and Humour 2
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Naming of newly merged department Miscellaneous Environmental Standards and EMS Related Discussions 4
A How to prepare QMS manual for purchasing department Quality Management System (QMS) Manuals 5
P Training department ideas and development for automotive supplier Training - Internal, External, Online and Distance Learning 6
H What ISO certification is for an IT department? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
BeaBea How do I incorporate the IT department Process Maps, Process Mapping and Turtle Diagrams 4
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Armen Conflict of Interest if I audit the QC department? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 10
S SOPs applicable for Regulatory Affairs department Other ISO and International Standards and European Regulations 1
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
Marc From the "I'm glad I'm retired" Department (Oct 2019) Career and Occupation Discussions 7
C Neglect or legitimate deferral? Is excessive workload or lack of resources in a department or a team a valid root cause for a non-conformance? Problem Solving, Root Cause Fault and Failure Analysis 15
T Legalizing ISO 13485 certification with an US state department of health ISO 13485:2016 - Medical Device Quality Management Systems 5
S Which department manages Establishment Registration, Device Listing and GUDID? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Outsourced processes how to interact with projects - We are an governmental department with 2 persons ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
E Department Plan for QA and HSE (profile, plans, structure, goals, etc.) Misc. Quality Assurance and Business Systems Related Topics 2
M Medical Device News Olympus Medical pleads guilty to failing to file events notice: Justice Department Medical Device and FDA Regulations and Standards News 0
J Implementation of Total Quality Management/Starting a Quality Department Reliability Analysis - Predictions, Testing and Standards 9
L How to manage a Metrology Department or Calibration Laboratory General Measurement Device and Calibration Topics 3
Q Risks and opportunities that could be associated with the purchasing department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B FDA Philippines has no check or balance outside the health department Supplier Quality Assurance and other Supplier Issues 3
S My department inherited a large number CAPAs ISO 13485:2016 - Medical Device Quality Management Systems 4
T Setting up a quality department in an Engineering Firm Quality Management System (QMS) Manuals 11
S Quality Department Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
E ISO 9001:2015 for Information Technology Department Human Factors and Ergonomics in Engineering 2
Q How do we document a department name change? Document Control Systems, Procedures, Forms and Templates 3
V Information Technology Dashboard - IT Department Performance Metrics IEC 27001 - Information Security Management Systems (ISMS) 2
P Re-Numbering Documents from the last Standard to Department and Title Document Control Systems, Procedures, Forms and Templates 11
L Ways to improve testing on our department - Project Kickoff Misc. Quality Assurance and Business Systems Related Topics 4
Q Department Expansion as a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Y TQM Implementation in Facilities Department Misc. Quality Assurance and Business Systems Related Topics 2
A How to boost morale of Inspection Department Quality Tools, Improvement and Analysis 10
A Quality Department - Operational Framework Service Industry Specific Topics 2
S Acquisitions and Joint Ventures (Business Development Department) and ISO 13485 EU Medical Device Regulations 3
A Operational Procedure for an IT Service Industry Quality Department Service Industry Specific Topics 1
T Internal Audit not done for Quality Department Internal Auditing 11

Similar threads

Top Bottom