Internal Auditing: New Product Launch

Anerol C

Trusted Information Resource
#1
Hi!
I'm looking for advice on what looking for on an internal audit that has been scheduled; there is a prototype being built in our facility; the product is a "huge" assembly (just one assembly - almost finished); our plant is not designing;

I think that I should look for prototype project status; functional test records completed; pending action items to be completed for other departmens; this is not a production line, no control plan and pfmea available,:bonk: What else I can looking for to verify that the "process to introduce new products is working fine ?

:thanx:
AC
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Hi!
I'm looking for advice on what looking for on an internal audit that has been scheduled; there is a prototype being built in our facility; the product is a "huge" assembly (just one assembly - almost finished); our plant is not designing;

I think that I should look for prototype project status; functional test records completed; pending action items to be completed for other departments; this is not a production line, no control plan and pfmea available,:bonk: What else I can looking for to verify that the "process to introduce new products is working fine ?

:thanx:
AC
Hello Anerol,

Prototype? No prototype control plan required? No PFMEA (yet)?
I don't know Anerol, it does not look like a good start to me..

Well, here are some audit ideas (proceed with caution...)
  1. List all the requirements for this prototype. (Input)
  2. Were all requirements for the prototype met? (Output)
  3. If not, explore the controls used for this process.
  4. Verify all parts of this prototype process.
I'm sure you'll come up with additional discoveries that require further exploration.

In addition, look here for more (APQP) audit ideas.

Stijloor.
 
Last edited:

Miner

Forum Moderator
Staff member
Admin
#3
I recommend auditing the records associated with the original contract review for this prototype.
 

Anerol C

Trusted Information Resource
#4
Well the reason that there is not Control Plan/PFMEA is because this industry is not automotive, it is ideal to have it but as this is not a requirements they are not in place:(;
Should I look for APQP even when this is not a requirement?:confused: As far as I know just a Gantt chart in Microsoft Project to see the status of advance and we are not designing,
Thanks for your comments,
Anerol
 
J

Jeff Frost

#5
Have you though of just using the requirements from ISO 9001:2000 7.3 Customer-related processes, Clause 7.3, Design and Development, and 7.5, Production and service provision?

Also look at these requirements related to the product during audit:

- What are the contractual requirements imposed by the customer (customer requirements)?
- What are the Mexican Federal Government requirements for product being produced (regulator/statutory requirements)?
- What are the regulator/statutory requirements for receiving country of the product being produced and exported (if applicable?)
 

Stijloor

Staff member
Super Moderator
#6
Well the reason that there is not Control Plan/PFMEA is because this industry is not automotive, it is ideal to have it but as this is not a requirements they are not in place:(;
Should I look for APQP even when this is not a requirement?:confused: As far as I know just a Gantt chart in Microsoft Project to see the status of advance and we are not designing,
Thanks for your comments,
Anerol
Hello Anerol,

Even though your organization is not "automotive", you could benefit from APQP guidelines. But that's obviously your choice. Jeff Frost gives excellent suggestions to include the requirements of ISO 9001:2000, clauses 7.1, 7.2 and 7.3. The main question remains: What are the requirements? That's what you audit against.

Stijloor.
 

Anerol C

Trusted Information Resource
#7
Here are some of the finding;
Let me know your opinion.

1.-There is a procedure where a "release process sheet" is called but nobody is taking care of it, the leader of the project tells that is not his responsiblity is Area Engineer responsibility.

2.-There is a planning on Prototype built; with status and progress, also a list of open and closed items, which I think it is fine, but there is not a planning on how the Prototype will be integrated on the production line, no timing on when they will get the fixture neither on lay out completion, engineers know what they need but not timing is established.

3.-The monitor and measurement records are not complete and there are some that are stating that some components are not to print, I need to look out if there is a deviation approved or an ECN.

I don't think we are performing very well.

Anerol:nopity:
 
J

Jeff Frost

#8
Looks like you have identified some of the issues with this process and at this point you should be linking them to the ISO 9001 standard requirements. If it don’t work or does not meet the Standard, or organizational procedures then the findings of nonconformity should recorded and a CAPA opened.

Some times organizations forget that they must first meet the requirements of the Standard and also their own documented procedures and work instructions. Internal auditors should write findings of nonconformity against the Standards requirements when they are observed.
 
#9
Here are some of the finding;
Let me know your opinion.

1.-There is a procedure where a "release process sheet" is called but nobody is taking care of it, the leader of the project tells that is not his responsiblity is Area Engineer responsibility.

2.-There is a planning on Prototype built; with status and progress, also a list of open and closed items, which I think it is fine, but there is not a planning on how the Prototype will be integrated on the production line, no timing on when they will get the fixture neither on lay out completion, engineers know what they need but not timing is established.

3.-The monitor and measurement records are not complete and there are some that are stating that some components are not to print, I need to look out if there is a deviation approved or an ECN.

I don't think we are performing very well.

Anerol:nopity:
Sounds to me like your process isn't well defined or documented. So, what happened? Perhaps doing an audit isn't worthwhile, since your management probably know that their prototype process is broken.

Anerol, is this the case? It's not really much use to do an audit if the process is not well defined, understood or implemented first. But you can use this opportunity to get your mgmt team to address it!
 

Jim Wynne

Staff member
Admin
#10
Looks like you have identified some of the issues with this process and at this point you should be linking them to the ISO 9001 standard requirements. If it don’t work or does not meet the Standard, or organizational procedures then the findings of nonconformity should recorded and a CAPA opened.

Some times organizations forget that they must first meet the requirements of the Standard and also their own documented procedures and work instructions. Internal auditors should write findings of nonconformity against the Standards requirements when they are observed.
The standard is not what must be met first. The requirements of the standard should be integrated into "the organization's" documentation such that direct reference to the standard is obviated.

Sounds to me like your process isn't well defined or documented. So, what happened? Perhaps doing an audit isn't worthwhile, since your management probably know that their prototype process is broken.

Anerol, is this the case? It's not really much use to do an audit if the process is not well defined, understood or implemented first. But you can use this opportunity to get your mgmt team to address it!
If the object of internal audit is to verify (or falsify) the working hypothesis that a functioning system is in place, I think that doing the audit in this case was useful, and served its purpose well. One compelling bit of evidence that there's a major problem in this case is this:
Anerol C said:
There is a procedure where a "release process sheet" is called but nobody is taking care of it, the leader of the project tells that is not his responsiblity is Area Engineer responsibility.
When a requirement hasn't been met because the responsibility and authority for fulfilling it hasn't been explicitly defined, you know something ain't right, and it's time to go back to the proverbial drawing board.
 
Thread starter Similar threads Forum Replies Date
S ISO 9001:2015 Internal Auditing Internal Auditing 8
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
S Risk based internal auditing Internal Auditing 6
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
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
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
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
N Online Internal Auditing Course for ISO 13485 - Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 8
U Internal auditing - Company employees or contract second party Internal Auditing 10
K Internal Auditing - Umbrella QMS and Multiple Standards Oil and Gas Industry Standards and Regulations 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
G AS9101 Rev F - Worksheets for internal auditing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S ISO 13485:2016 and MDSAP internal auditing ISO 13485:2016 - Medical Device Quality Management Systems 6
S ISO 9001:2015 - Internal Auditing - Audit to the Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R Internal Auditor auditing Internal Audit Procedure (AS9100) Internal Auditing 18
M Is Automated Internal Auditing Possible? Internal Auditing 13
C Internal Auditing Requirements (ISO 9001:2008) Internal Auditing 3
L Auditing Design and Development in ISO 9001 (Internal Audit) Internal Auditing 1
sswaim Auditing Internal Laboratory Personnel for Competence General Auditing Discussions 4
K Internal Auditing a previous Nonconformance? Internal Auditing 19
P Recommended books on ISO 27001:2013 Implementation and Internal Auditing IEC 27001 - Information Security Management Systems (ISMS) 4
M Are auditing checklists required for Internal Audits? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
B ISO/TS16949 Internal Auditing - How many auditors? Internal Auditing 4
B PFMEA, Internal Auditing, Corrective Action Training In Native Language (China) Training - Internal, External, Online and Distance Learning 1
Gman2 Internal Auditing Requirements before ISO 9001 Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Auditing TS 16949 Cl. 7.6.3.1 - Internal Calibration Laboratory Requirements IATF 16949 - Automotive Quality Systems Standard 8
T ISO 9001 Internal Auditing Auditor Training in Amsterdam Training - Internal, External, Online and Distance Learning 1
S In an internal auditing desert and I'm the only one here.... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
G Internal Auditing in a Multi-Site Environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
B Internal Auditing of MDD and CMDR Requirements Other Medical Device Related Standards 5
O Internal Auditing in small Engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T Looking for a webinar on Internal Auditing General Auditing Discussions 3
R On Auditing Internal Audit Process - How Independence can be Established Internal Auditing 4
D Auditing Abroad - Internal Audits of our European Sister Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
R Auditing a process outside the realm of the formal Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
G New to Internal Auditing - Best questions to ask? Internal Auditing 17
M Auditing the Internal Audit Process - 8.2.2 General Auditing Discussions 2
J Auditing the Internal Auditing Process - Audit Nonconformance General Auditing Discussions 3
S Internal Auditing related to RISK Internal Auditing 9
W Internal Auditing - Observational Checklist for a Behavior Based System Internal Auditing 3
R Internal Auditing Checklist - Major NCR because the Checklist was not Completed Internal Auditing 17
V Depth of Internal Auditing and Training aspects in Research & Development (R & D) Internal Auditing 4
N Good Internal Auditing Training Courses Training - Internal, External, Online and Distance Learning 13
L Internal Auditing Reports / Documents - Design and Content Document Control Systems, Procedures, Forms and Templates 1
N Recommend internal auditing training 101 please (Tucson or Phoenix, AZ) Training - Internal, External, Online and Distance Learning 1
L Internal Auditing - How can I audit my QMS independently? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Internal Auditing - How to make it useful? Internal Auditing 36

Similar threads

Top Bottom