ISO10005 Quality Plan Inputs

[Dazzur]

Good Morning Cove,

As a prior, if required please move this to the appropriate forum, I placed it here as my organisation is 9001 certified and these are the guidelines I'm working within.

To the question,

I've been tasked with producing a Quality Plan specific to a Product, The quality plan has been requested by the regulatory body before we're allowed to manufacture these, which I'm mostly fine with, ISO 10005:2018 gives plenty of guidance on this which is all well & good, however I'm currently a little confused around "6.3 Quality Plan Inputs", I'm also using "5.2 Inputs to the Quality Plan as guidance"

I'd like to document the inputs in some sort of workflow process chart but I'm not sure where to begin, I 'think' I have a rough idea but I'm not entirely sure, I can't seem to find any resources that explain in a way I can understand.

Is any body able to explain (Like I'm a 2 year old) or share/link resources to which would aid me in this?

I would be ever so grateful should anyone be of assistance, have a lovely day.

Thank you.

 

[John C. Abnet]

Good Morning Cove,

As a prior, if required please move this to the appropriate forum, I placed it here as my organisation is 9001 certified and these are the guidelines I'm working within.

To the question,

I've been tasked with producing a Quality Plan specific to a Product, The quality plan has been requested by the regulatory body before we're allowed to manufacture these, which I'm mostly fine with, ISO 10005:2018 gives plenty of guidance on this which is all well & good, however I'm currently a little confused around "6.3 Quality Plan Inputs", I'm also using "5.2 Inputs to the Quality Plan as guidance"

I'd like to document the inputs in some sort of workflow process chart but I'm not sure where to begin, I 'think' I have a rough idea but I'm not entirely sure, I can't seem to find any resources that explain in a way I can understand.

Is any body able to explain (Like I'm a 2 year old) or share/link resources to which would aid me in this?

I would be ever so grateful should anyone be of assistance, have a lovely day.

Thank you.

Good day @Dazzur ;
I understand that you have been tasked with "producing a quality plan specific to product". What would help me/us in order to best help you is if you can explain to us WHY you have been tasked with this. What is the goal? (I.e. what is the outcome your organization is seeking to achieve by ""producing a quality plan specific to product?"

Thank you in advance
Be well.

 

[Dazzur]

Good day @Dazzur ;
I understand that you have been tasked with "producing a quality plan specific to product". What would help me/us in order to best help you is if you can explain to us WHY you have been tasked with this. What is the goal? (I.e. what is the outcome your organization is seeking to achieve by ""producing a quality plan specific to product?"

Thank you in advance
Be well.

Hi John, thank you for your reply.
The reason I've been tasked with this is that we need to adhere to the requirements of 'BRE Global PN111 Factory Product Control' for the manufacture and provision of Security rated Fencing Grade: 1 (This is in the UK to clarify).

We were audited on the 16th & 17th of March by a BRE auditor, we admitted we were no where near ready (out of my control) but would use the opportunity as a GAP analysis of sorts, here is her finding regarding the Quality Plan:

"Clause 2: There is currently not a fully completed- Documented Quality Plan (that clearly cross refers to BREG certification, defining the products or service realisation for the approved products). Eg key process documentation, critical components list/details, technical files etc."

PN111 Clause 2 section C states:

"c) A documented Quality Plan (That clearly cross refers to BREG Certification) defining the product of service realisation process is established for each approved product. making references to key process documents, critical components lists/details, document register, technical file, inspection stages & supporting inspection plans & documents."

Whilst the auditor has only really repeated their findings as per the PN111 clause, it still stands.

We have 45 days to respond to the findings.

Thank you.

 

[John C. Abnet]

Hi John, thank you for your reply.
The reason I've been tasked with this is that we need to adhere to the requirements of 'BRE Global PN111 Factory Product Control' for the manufacture and provision of Security rated Fencing Grade: 1 (This is in the UK to clarify).

We were audited on the 16th & 17th of March by a BRE auditor, we admitted we were no where near ready (out of my control) but would use the opportunity as a GAP analysis of sorts, here is her finding regarding the Quality Plan:

"Clause 2: There is currently not a fully completed- Documented Quality Plan (that clearly cross refers to BREG certification, defining the products or service realisation for the approved products). Eg key process documentation, critical components list/details, technical files etc."

PN111 Clause 2 section C states:

"c) A documented Quality Plan (That clearly cross refers to BREG Certification) defining the product of service realisation process is established for each approved product. making references to key process documents, critical components lists/details, document register, technical file, inspection stages & supporting inspection plans & documents."

Whilst the auditor has only really repeated their findings as per the PN111 clause, it still stands.

We have 45 days to respond to the findings.

Thank you.

Understood...thanks for the clarification. I am based in the US and have no competency regarding the PN111 standard you are referring to. I will say, however, that this sounds somewhat consistent with an automotive control plan, wherein the specifications of the PROCESS (speed, RPM, dwell, pressure, temperature, etc...) and the specifications of the PRODUCT (length +/-,, density +/-, weight +/-, diameter +/-, etc..etc...) and associated CONTROLS (digital monitor, work instruction, DC torque and angle install tool, etc..etc.., are stated for each step of the manufacturing process. Therefore, assuming you have no/cannot locate the understanding or template specific to PN111, you may wish to search on line for an "APQP---automotive control plan" as an assumed similar reference.

Hopefully someone here can jump in with information/knowledge specific to the PN111 you are working with.

Please allow me to provide some council in regard to the inference that the impetus for developing is "...we need to adhere to the requirements...". While I understand this may be the initial motivation, I would encourage you and your organization to develop the required system and control plan(s) selfishly and establish them to meet and benefit your ORGANIZATION"s need and not simply because of auditor and/or customer prescribed obligation.

Hope this helps.
Be well.

 

[Dazzur]

Hello again and thank you for the replies, I looked into APQP but I'm not sure it's something I have the knowledge to complete.
I've created my first Incomplete draft of my Quality Plan for the specific case.

I've used ISO 10005, 9000 & other sources quality plan examples around the internet to try and accomplish this.

I've attached it, if some one could possibly review it and give feedback I'd be grateful, as I'm not really sure what if what i'm doing is appropriate.

Thank you

 

[qualitymanagerTT]

...
I've been tasked with producing a Quality Plan specific to a Product, The quality plan has been requested by the regulatory body before we're allowed to manufacture these, which I'm mostly fine with, ISO 10005:2018 gives plenty of guidance on this which is all well & good, however I'm currently a little confused around "6.3 Quality Plan Inputs", I'm also using "5.2 Inputs to the Quality Plan as guidance"

...

I'm very happy to hear that ISO 10005:2018 gives plenty of guidance.

I've never heard of PN111 or LPN1177, but I was very familiar with ISO 10005 some years ago.

(1) I found that your Quality Plan, sect. 2.2 is light on the list of inputs. Have you considered each item in ISO 10005 clause 5.2 (a) to (i)? Could you provide a list with each of these items, and details (to the extent confidentiality allows) on what is applicable?

As an example, let's assume the Quality Plan is for making tuna sandwiches. Addressing clause 5.2 f) requirements for and availability of resources could be something like:
"The resources required for this Quality Plan are:
- 3 sandwich makers (people),
- ingredients as listed in document number SAN-TUN-003,
- food grade metal preparation tables, and other equipment as specified in document number SAN-EQP-001,
- Kitchens #1 to #3 in Building 7, with all utilities operating as in specified document number FSMS-UTL-006,
- Procedure SAN-TUN-001 (which includes the recipe)".

(2) Your Quality Plan, sect. 8.1 is also very light. I would like to think that the table (QMS ref. vs. Inspection Type) has been developed by extracting relevant information from the product standards you listed, but wherever you are referencing other documents in the Quality Plan, those other documents have to provide adequate information.

I suggest spending some time to ensure that each applicable item in ISO 10005 clause 6.16 (a) to (h) is adequately addressed in the documents referenced in your Quality Plan.

(3) After you've done those things, if you have time, I suggest you carefully examine ISO 10005 Annex B, Figure B.1 - understanding how the process approach shown is applied to designing, implementing, managing and improving Quality Plans will definitely help you the next time you need to do one.

Good luck, and feel free to message me if I don't reply in a timely manner.