Auditing New Product Introduction Process

[Kloser43]

Hi all,

I have been given the task of auditing my company's New Product Initiation process. Key area to focus the audit is ISO 9001:2008 section 7, however in an environment of sub-contracting manufacturing I know that document control, monitoring and measuring, control of non-conformance are all very important as we are handing over manufacturing to sub contractors. Can someone point to the key factors/questions for the audit? It seems very vast right now...

Background: The company designs life jackets to be manufactured by sub-contractors abroad. Current method is unorganized, but essentially: Determine new product requirements / New project Quality Plan / Steps of product realization (design, testing verification validation, documentation, monitoring measuring etc)

 

[Chennaiite]

Re: Auditing New Product Initiation Process

PDCA approach is the great starting point. Some starters;

Plan
Are methodologies defined to obtain Customer requirements?
Are Customer requirements refined to indicate product requirements in objective terms?
Are Quality, Cost, Delivery measures available with operational definition?
Are targets fixed for QCD measures?
Is procedure defined for New Product initiation?
Are process deliverables defined?
Is time plan prepared based on procedure?
Are verification, validations planned as per procedure at appropriate intervals?
Are standard for Verification/Validation available and approved?
Are reviews planned at appropriate intervals?
Is the Project Organization defined, competitive and Cross functional in nature?

Do
Have all above been carried out as per plan?

Check
Are Verification/Validation results, Process deliverables, etc checked against planned acceptance criteria?
Are QCD results checked against planned target?
Are reviews carried out against set of criteria?

Act
Have all the gaps identified during 'Check' stage, followed up with Correction, Containment action, Corrective action, Preventive action whichever is deemed appropriate?
Are Lesson learned compiled and documented?
Are design changes planned and if so, appropriate 'Plan' points as above are adhered?

 

[AndyN]

Re: Auditing New Product Initiation Process

Hi all,

I have been given the task of auditing my company's New Product Initiation process. Key area to focus the audit is ISO 9001:2008 section 7, however in an environment of sub-contracting manufacturing I know that document control, monitoring and measuring, control of non-conformance are all very important as we are handing over manufacturing to sub contractors. Can someone point to the key factors/questions for the audit? It seems very vast right now...

Background: The company designs life jackets to be manufactured by sub-contractors abroad. Current method is unorganized, but essentially: Determine new product requirements / New project Quality Plan / Steps of product realization (design, testing verification validation, documentation, monitoring measuring etc)

What's the purpose of the audit? If this process is, as you say, unorganized, what is to be achieved by attempting to audit it - especially as it appears you haven't had experience.

 

[Kloser43]

Re: Auditing New Product Initiation Process

Hi Andy,

The purpose of the audit is to identify any gaps in the current process/procedure, which I suspect there will be. It's a learning curve for myself, and I will be working with a more experienced QA Manager. I just wanted some feedback from people outside of the company, who have knowledge of auditing NPI procedures.

 

[AndyN]

Re: Auditing New Product Initiation Process

Hi Andy,

The purpose of the audit is to identify any gaps in the current process/procedure, which I suspect there will be. It's a learning curve for myself, and I will be working with a more experienced QA Manager. I just wanted some feedback from people outside of the company, who have knowledge of auditing NPI procedures.

This now leaves me with more questions - for example, you say gaps, do you mean the design group doesn't have a defined process? You say there are gaps - this is a form of bias, which auditors should not have. Are you saying it's not organized because you KNOW they have a poorly defined process or is this hearsay?

Also, are you auditing with the QA mgr as a lead auditor? Has the QA mgr involved you in planning this audit?

You see, asking us is quite frankly, going to confuse you because, for example, I could lay out my knowledge of NPI which will blow you away because it was a very effective process and fairly complex, but then you don't develop state of the art business machines - so what I tell you has no relevance.

I'd suggest you ask the QA mgr what is going on, what your role is, then study the NPI process (if it is documented) or sit down the the NPI process owner and understand what they say happens, first.

 

[Kloser43]

Re: Auditing New Product Initiation Process

I'll try and answer one question at a time. Yes, they do not have a defined process. We know there are gaps in the NPI process due to a number of reasons. 1: NPI has not been previously audited. 2: All projects have suffered due to various issues such as a lack of planning/effective risk assessment etc etc resulting in delays, high costs, non-conformance's.....the list goes on.

Yes QA Manager is lead auditor. I however have been thrust into planning the audit due to unfortunate circumstances with said lead auditor being unavailable for parts of the working week.

Please understand that I am only asking for advise on say; ISO sections of most importance, key focus points....not a template of Audit questions (as you say, all companies are different). I am of course consulting the QA manager, however time and resource is currently against us.

Many thanks

 

[AndyN]

Re: Auditing New Product Initiation Process

I'll try and answer one question at a time. Yes, they do not have a defined process. We know there are gaps in the NPI process due to a number of reasons. 1: NPI has not been previously audited. 2: All projects have suffered due to various issues such as a lack of planning/effective risk assessment etc etc resulting in delays, high costs, non-conformance's.....the list goes on.

Yes QA Manager is lead auditor. I however have been thrust into planning the audit due to unfortunate circumstances with said lead auditor being unavailable for parts of the working week.

Please understand that I am only asking for advise on say; ISO sections of most importance, key focus points....not a template of Audit questions (as you say, all companies are different). I am of course consulting the QA manager, however time and resource is currently against us.

Many thanks

Ok - so here's my concern: auditing a process which hasn't been formally defined and/or documented is politically dangerous! Most of the issues you describe can be fixed if the process were defined. Auditing will be perceived as piling on the criticism/a witch hunt. If the QA manager doesn't understand this, I'd personally be very worried.

Why do I know this? It's exactly how I got into auditing! My reputation with some people was ruined as long as they or I worked at the company.

Unless you are doing a gap analysis - with managements' approval, to determine how the process compares to ISO 9001 - and it doesn't sound like it is - there will be some collateral damage. Someone needs to know this.

 

[Sidney Vianna]

Re: Auditing New Product Initiation Process

Background: The company designs life jackets to be manufactured by sub-contractors abroad. Current method is unorganized, but essentially: Determine new product requirements / New project Quality Plan / Steps of product realization (design, testing verification validation, documentation, monitoring measuring etc)

Kloser, one aspect that the audit MUST take into account with a LOT of attention is how your system ensure compliance with REGULATORY REQUIREMENTS for the products.

OBVIOUSLY, life jackets are a very critical product and, in the USA, they have to comply with CFR 46, Part 160 PART 160 — LIFESAVING EQUIPMENT [ 46 CFR 160 ].

When you outsource production of a regulated product such as this one, it is EXTREMELY important to understand how the design of the product is assured to comply with the requirements and how your suppliers will do their share to ensure that the product is in full conformity with the approved design.

In the past, people trying to demean ISO 9001 used to say that you could make life jackets out of concrete and still be ISO 9001 certified. A myth I debunked many years ago.


Good luck.

 

[pldey42]

I agree with Andy and Sidney. This is not an area to over-simplify.

My limited experience of this area (an audit of a manufacturer of body armour) is that it relies critically upon experienced designers, so the design process may well appear unorganized - creativity always is.

Two questions:

Why audit? Are you going for ISO 9001 certification? Already have it?

What does "we are handing over manufacturing to sub contractors" mean? If it means that previously you did manufacturing yourselves, and now plan to subcontract, bearing in mind Sidney's regulatory requirements, not to mention the costs in terms of damage and distress to accident victims, there are serious issues to address.

The idea of key focus points is surely misguided. A management system is just that, a system. It all has to be there if it is to work properly. In my experience of auditing software organizations and their design processes, such are complex and critically reliant upon skill, for they are always doing something new - that's why they're designing: if they were not doing something new, an existing design would suffice. So the very nature of design is that it cannot be fully organized. It's more like jazz, a mixture of structure and improvisation.

As Andy said, before auditing, I would strongly counsel mapping the design processes with those who do them, to determine what can be "organized" and what relies purely upon skill, before attempting to audit. People, designers especially, do not like being audited against requirements that are not specific, and won't tolerate being audited by people who do not understand design. Worst case, with inappropriate audits, their morale will go down and there is a risk of losing key people.

Hope this helps
Pat

 

[Kloser43]

Re: Auditing New Product Initiation Process

Hi Andy, I think I have failed somewhat to make this clearer. We have a documented NPI procedure, however it is not defined enough, hence the audit. I assure you the purpose of the audit has not only been agreed by Management, but QA & Design management. I have been in meetings with the MD, Design Manager, QA Manger and discussed the urgent need for an internal audit of the NPI process because of the failures of previous NPI projects. This is not purely a QA power-trip exercise, as you say, this would only ruffle feathers. This is a requirement agreed across departments. This audit will go some way to identify current gaps in the processes/procedures.