Auditing 5.4.2 Quality System Planning

J

Jamie

#1
#1
A dumb question if you will.....I'm working on my Audit Checklist for my "first" internal audit on our system since the changes. One particular item in this audit covers 5.4.2. My question.....if you were auditing this what would be some of the things you'd look for? Just curious.

Jamie
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
R

Russ Kochis

#2
#2
Jamie,
I feel that the evidence of quality planning is obtained from the audit results of all other elements. 5.4.2 references 4.1 which is essentially a brief summary of the overall ISO 9001 requirements. It also refers to maintaining integrity during change and meeting quality objectives.

The evidence of effective planning is the demonstration of a system that operates effectively in your organizations environment. You indicated that your organization recently underwent change, is there evidence that the change was controlled? Where customer requirements consistently met during the change? Was senior management briefed on the progress and impact of the change? Where system or process failures noted during the change?

Management review is an important record of quality planning. Are the quality objectives reviewed/revised as needed? Are the needs for and results of system change reviewed? Is the overall effectiveness of QMS monitored, measured and reviewed?

What type of planning occurs for corrective and preventive actions and how are they documented? How does your organization plan for new equipment, processes, products, etc?

Are internal audit results reviewed to determine if project or program planning were casual contributors to nonconformances?

This is the method that is used at my organization and it has worked well. I hope this this has helped you a little.

Russ Kochis
 
M

M Greenaway

#3
#3
Try looking at how new processes or new products are introduced. This can be difficult for some companies that have a well established process and undertake no product design.
 
B

barb butrym

Quite Involved in Discussions
#4
#4
points to look at:

look at how "critical to quality points" are identified and handled

look at how customer requirements from contract review are communicated to the factory and included in the plan (router/ traveler?)

how do you plan for/provide resources to support new processes/materials. how do you identify training needs?

how is a design released to the factory?
 
R

rak

#5
#5
I would look into issues such as Customer complaints, late deliveries, product non-conformities, Cost of Quality, Project delays, essentially, all issues which would indicate lack of effective planning.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Auditing ISO9001/AS9100 7.3 Design and Development Quality System Effectiveness Manufacturing and Related Processes 12
B Process Approach to Auditing Quality Management System Internal Auditing 12
S Quality Auditing System - Audit Plan per guidance from ISO 19011 Internal Auditing 8
C Does auditing improve a Quality or Business System? Internal Auditing 7
M Auditing IT department quality General Auditing Discussions 2
K Internal Auditing of Project Quality Plans General Auditing Discussions 5
M Auditing Test Management Software such as HP Quality Center (HPQC) Test Tool Internal Auditing 1
B I have a question for people working in quality management auditing Career and Occupation Discussions 17
H Quality Management Best Practices for Internal Auditing Internal Auditing 6
V Outsourcing Internal Quality Auditing functions Internal Auditing 26
A Auditing sufficiency of documented quality objectives vs the real process Internal Auditing 14
A Checklist for Auditing the Quality Dept. (I need your comments) Internal Auditing 14
V Internal Quality Audit - Themes for auditing the company QMS Internal Auditing 1
V How to do the IQA (Internal Quality Auditing)? Internal Auditing 4
J Quantify Quality Objectives? Auditing company's documented interpretation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Crusader Internal Auditing for ISO/TS-16949 - Quality Digest article May 2006 General Auditing Discussions 1
A Internal Auditor training - Recommendations regarding a video on quality auditing Training - Internal, External, Online and Distance Learning 2
S Quality Audit Skills - Working on the development of an Auditing Skills training tool Training - Internal, External, Online and Distance Learning 4
S What is APA/BPA auditing? DaimlerChrysler quality auditor - China General Auditing Discussions 9
J Guidelines for auditing Quality Systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Auditing COT's Suppliers / First Post Supplier Quality Assurance and other Supplier Issues 2
K ISO 9001 Auditing in a Healthcare setting Process Audits and Layered Process Audits 15
S ISO 9001:2015 Internal Auditing Internal Auditing 8
H Auditing Santa's workshop General Auditing Discussions 0
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
J Auditing of Support Function IATF 16949 - Automotive Quality Systems Standard 9
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S Risk based internal auditing Internal Auditing 6
Randy Remote auditing (for disaster, disease, disturbance etc...) during the Neo Coronavirus Pandemic and Social Distancing Registrars and Notified Bodies 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 1
F AS9100D Internal auditing requirements Internal Auditing 11
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
tony s What is the automotive process approach for auditing? IATF 16949 - Automotive Quality Systems Standard 2
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
R I've been auditing for a CB for 18 years General Auditing Discussions 10
P Consultant Auditing Qualifications Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 149
M We still have not received our certificate due to a 'backlog' with our auditing body Registrars and Notified Bodies 25
N Online Internal Auditing Course for ISO 13485 - Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 8
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
U Internal auditing - Company employees or contract second party Internal Auditing 10
J Recomended Values - Auditing process in a supplier IATF 16949 - Automotive Quality Systems Standard 18

Similar threads

Top Bottom