Process Audit Checklist to document Internal Process Audit results

J

jim543

Can anyone share already developed Process Audit Checklists that are being used to document Internal Process Audit results?

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Jim543
 
D

donnammurphy

Any time you perform process audits, you need to look at the following elements along with 4.9 process control, document and data control, product id and traceability, control of nonconforming product, calibration, training, inspection and testing and inspection and test status. When I schedule a process audit, I will use, as a guide, the standard ISO checklist questions as used by my registrar. Hope this helps..

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E Wall

Just Me!
Trusted Information Resource
I'm in the middle of doing the process reviews for each department, this is what I'm using as a general format (add items where needed):

For each dept - ID the Key process then complete.

Header Includes: Department & Review Dates
Footer includes: Page #'s, Resources used, preparer name

I. Process: Process Type:
a. Inputs:
i. Processed Material:
ii. Services:
iii. Hardware/Equipment:
iv. Software:

b. Activities:

c. Outputs:
i. Processed Material:
ii. Services:
iii. Hardware/Equipment:
iv. Software:

d. Goals:

e. Objectives:

f. Metrics:

For each area, I'm also identifying what documentation is in place (Corporate Specs, Plant Work Instructions, Standard Operating Procedures, Forms (include 1st Piece, identification, Control/Spec charts...etc)

I have this file in word format if you want a copy, e-mail me and I'll reply with the attachment.
 

E Wall

Just Me!
Trusted Information Resource
Okay, realized I misread your question. I'm using the process review as a tool for the transition, not for Internal Auditing.
 
B

begum

the standard ISO checklist questions

donnammurphy said:
Any time you perform process audits, you need to look at the following elements along with 4.9 process control, document and data control, product id and traceability, control of nonconforming product, calibration, training, inspection and testing and inspection and test status. When I schedule a process audit, I will use, as a guide, the standard ISO checklist questions as used by my registrar. Hope this helps..

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Forgive me for asking this question, but what are "the standard ISO checklist questions "?

Begum
 
S

SULTANZUBAIRI

ISO 9000:2000 Audit Checklist
Compliance
Comment
No.
Requirement
N/A Satis Minor Major
Page 1 of 22 6/19/03
L.Benson
4 Quality management system 4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization shall a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyze these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this International Standard. NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.
 
S

SULTANZUBAIRI

Last edited by a moderator:
Q

qualityboi

PDCA Checklists

I have heard about PDCA auditing only in brief. Does anyone have information or checklists about PDCA auditing? Is it any different from any other audit :topic:
I am I getting confused between process audits and the process approach to auditing?
:tg:
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
qualityboi said:
I have heard about PDCA auditing only in brief. Does anyone have information or checklists about PDCA auditing? Is it any different from any other audit :topic:
I am I getting confused between process audits and the process approach to auditing?
:tg:

PDCA auditing is process auditing in my view. A process can be formalized (and documented) in a PDCA format - we are in the process of converting ours into such a format. We highlight the planning/initial steps to process, what steps are the "Do", how we check, and any actions that may be taken.

To audit the process is to audit the PDCA of the process.
 
Q

qualityboi

PDCA auditing

RCBeyette said:
PDCA auditing is process auditing in my view. A process can be formalized (and documented) in a PDCA format - we are in the process of converting ours into such a format. We highlight the planning/initial steps to process, what steps are the "Do", how we check, and any actions that may be taken.

To audit the process is to audit the PDCA of the process.

I guess I was under the impression that it was more of a technique or tool rather than standard use. The ASQ Quality Audit Handbook doesn't mention it as a technique or tool however, ASQ is selling a book that just deals in PDCA auditing as if were different from and more beneficial than say the "traditional" technique, (whatever that is).

Thanks,

James
 
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