SBS - The Best Value in QMS software

Quality plans - How much detail is required? What is typically included?

D

Daryl MacNeil

#1
Quality plans

I'm sorry if this is too general for this list, but I have a question about Quality Plans.
The majority of Quality Plans I have seen have simply mirrored a company's Quality Manual and included high level information (Q Policy, Doc. Control, Corr. Action, etc.).
I believe Quality Plans should be more specific and just refernce the higher level stuff if neccessary. I would like to write a Quality Plan that is more detailed and indicates specific product inspections, how nonconfomances are handled (MRB approvals?), what information will be reported, etc.

What is the norm lately for writing quailty plans? What do organizations find most useful?

Thanks for any feedback,
Daryl
 
Elsmar Forum Sponsor
S

Spaceman Spiff

#2
I find using the AIAG Control Plan format extremely useful (one of only a few useful things from AIAG!)

------------------
 
#3
Consider what your goals are with writing this and any other document. What do you want to achieve ? Better process control ? Then the focus should be at identifying the critical process variables and how do you keep them in line. Improved understanding from the people ? then get away from extremely technical terms (for example instead of "frecuency" write "how often", etc.) Comply with customer requirements ? then ask them if they mandate or prefer a specific format but be careful to customize to your needs without loosing the essence.
A final warning - think twice if you want to over complicate this stuff - start easy and be very focused.

Regards

Gus Gutierrez
[email protected]
 
A

Alan Cotterell

#4
I suggest the basic form of a quality plan should be the 'process flowchart' which shows how a project passes through the organisation. Linking the procedure number to the flowchart gives a more extensive overview which may be used as the basis of second party audits. These audits, performed by the customer, relevant to his contract, are probably the prime reason for the existence of the quality plan.
 
C

Christian Lupo

#5
The most effective control plans I've seen and what I think you are looking for is the methodology used by the automotive industry. It begins with creating a flow diagram, from that creating a PFMEA, followed by a control plan. The AIAG manuals referenced ealier are excellent.
 

barb butrym

Quite Involved in Discussions
#7
A process flow, indicating control points (Critical to Quality...CTQ) and detailed criteria..pointing to process procedures and systems as required. Most people use a part specific router/traveler as the output of a quality plan, supported by the input that was used to create it.
 
A

Andy Bassett

#8
I cant offer much help, just maybe a bit of commiseration.

I also find that when i right-up the Quality Planning phase i am just simply repeating what i have said in my Corrective Action or Inspection or Process Control procedure.

It has always seemed to me to be a bit of a useless element.


------------------
Andy B
 
A

Alan Cotterell

#10
There is a simplified approach to quality planning used as an 'Inspection & Test Plan' (ITP) which is derived from the 'Project Task List' during contract review activities. The normal ITP form has provision for responses to Task, Relevant Document (Procedure or Drawing), Signatures for the operator and inspecting authorities.
ITP's are generally used for 'project based' activities rather than continuous production. I have only seen reference to ITP's in one Australian Standard (for the construction industry), but it's not a bad approach for a project based organisation undertaking 'jobbing' work.
 
Thread starter Similar threads Forum Replies Date
J How to make Quality Control plans Quality Tools, Improvement and Analysis 5
V What plans have been put in place to achieve quality objectives? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Moumen H Controls to ensure that Quality Plans are accurate APQP and PPAP 2
B Control Plans for Quality Management System Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Steps to Complete Quality Control Plans and Work Instruction Manufacturing and Related Processes 4
C Writing Quality Management Plans for a Tender Submission Quality Manager and Management Related Issues 4
A Recertification ISO 9001:2008 - 5 Different Divisions, so 5 Different Quality Plans ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K Internal Auditing of Project Quality Plans General Auditing Discussions 5
B Is anyone familar with ISO 10005 Guideline for Quality Plans? Other ISO and International Standards and European Regulations 2
A Management changes - Changing the apex manual of the company and Quality Plans Document Control Systems, Procedures, Forms and Templates 6
somashekar ISO 10005:2005 - Quality Management Systems - Guidelines for Quality Plans. Other ISO and International Standards and European Regulations 4
L ANSI/ISO/ASQ Q10005-2005: Quality management ? Guidelines for quality plans Other ISO and International Standards and European Regulations 2
J Quality Manuals and Quality Plans - Whats the difference? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
D Quality Planning Standard needed - ISO 10005:2005 - Guidelines for Quality Plans? Other ISO and International Standards and European Regulations 3
H Planning of Product Realization (Quality Plans) - Clause 7.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Supplier Quality Plans - Non-automotive company - Seeking examples Supplier Quality Assurance and other Supplier Issues 7
W ISO 10005 Guidelines for Quality Plans - Do we need an SOP? ISO 13485:2016 - Medical Device Quality Management Systems 1
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
A 4.2.3a "Preparation of Quality Plans" vs. 4.2.3.7 "Control Plan" - Differences? QS-9000 - American Automotive Manufacturers Standard 1
C Quality Plans - Does ISO 9001:2000 require the use of Quality plans? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Quality assurance area Manufacturing and Related Processes 2
C Quality Management System Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
K Quality Control/Assurance in the Metal Industry Quality Tools, Improvement and Analysis 10
C Quality Manager as part of Management - 13485 ISO 13485:2016 - Medical Device Quality Management Systems 9
Marc Quality Assurance Specialists Job Openings, Consulting and Employment Opportunities 0
B Quality Manager Retiring IATF 16949 - Automotive Quality Systems Standard 5
S Outsourced storage Quality Agreement ISO 13485:2016 - Medical Device Quality Management Systems 7
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
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 6
A Quality Control Datasheets Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
T Quality auditor legal right to see Board meeting minutes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D Any recommendations on where to find experienced quality hires in Chicago area? Job Openings, Consulting and Employment Opportunities 2
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

Similar threads

Top Bottom