So let’s get down to it. The three topics in this blog will be; Design and development planning; Design and development inputs; Design and development outputs.
Design and development planning; you must plan and control the design and development of product through staging, review, verification and validation of each stage, assign responsibilities, manage the interface between responsibilities and groups, with any resultant design plan being updated as needed concerning the process. I have seen one page plans, 200 page plans. Simple Gantt charts and very complex MS Project type one. Just remember the above elements and have a plan.
Design and development inputs; inputs will include functional and performance requirements, applicable statutory and regulatory requirements, where applicable, information derived from previous similar designs, and other requirements essential for design and development. Yes, the ‘other’ requirements. Now here is the easy bit. These inputs are to be reviewed for adequacy, will be complete, unambiguous and not in conflict with each other. So easy. Just keep the above in mind when developing your plan.
And finally, design and development outputs are to be provided in a form that enables verification against the design and development input and approved prior to release. These outputs should meet the input requirements for design and development, provide appropriate information for purchasing, production and for service provision, contain or reference product acceptance criteria, and specify the characteristics of the product that are essential for its safe and proper use.
My head hurts. Just keep these as components of your plan and all should be good. Part 3 next fortnight.
Monday, 28 May 2012
Monday, 21 May 2012
Avoid the hangover and the hump
It’s been three months since you were certified. Do you still have that inner glow from a ‘job well done’? You should. But now you need to avoid any hangover and you definitely need to avoid the ‘hump’.
Some companies think that certification is a race. You cross the finish line and dine on the success forever. But the certification isn’t the end. It is only the beginning and if you are not careful, that wonderful hangover of success can be quickly replaced with the threat of your certification being suspended. What? Can they do that? Sure can. Your certification body (CB) will be back within 6 months of your certification and they will be looking for a number of things. Did you record the findings from the audit in your own corrective action system or management review? Have you fixed them? Have you met your frequencies for internal audits, management reviews, corrective actions, calibrations, etc, etc.? Have new employees been made aware of their impact on the system and so on and so on. Yikes, that seems a tonne of work. Yes it is. So to ensure you aren’t faced with suspension threats, keep the project rolling.
BUT (yes, capitals) do not leave it to the last minute. Don’t create that ‘hump’ of work / activity as you ready for the next audit. Spread it out. Take your time. Review your frequencies and so on. Companies who create hump days or in fact hump weeks just to ‘pass’ audits are not doing themselves or their company any favour. And once your astute CB gets wind of the humping, the more clever of them (some say, the more caring of them), will find ways to show management that hump quality is not good quality.
Some companies think that certification is a race. You cross the finish line and dine on the success forever. But the certification isn’t the end. It is only the beginning and if you are not careful, that wonderful hangover of success can be quickly replaced with the threat of your certification being suspended. What? Can they do that? Sure can. Your certification body (CB) will be back within 6 months of your certification and they will be looking for a number of things. Did you record the findings from the audit in your own corrective action system or management review? Have you fixed them? Have you met your frequencies for internal audits, management reviews, corrective actions, calibrations, etc, etc.? Have new employees been made aware of their impact on the system and so on and so on. Yikes, that seems a tonne of work. Yes it is. So to ensure you aren’t faced with suspension threats, keep the project rolling.
BUT (yes, capitals) do not leave it to the last minute. Don’t create that ‘hump’ of work / activity as you ready for the next audit. Spread it out. Take your time. Review your frequencies and so on. Companies who create hump days or in fact hump weeks just to ‘pass’ audits are not doing themselves or their company any favour. And once your astute CB gets wind of the humping, the more clever of them (some say, the more caring of them), will find ways to show management that hump quality is not good quality.
Monday, 14 May 2012
Design and development – Part 1 of 4
Yes. One of four for this stupidly complex clause of the standard. Why there are so many requirements and so much baggage is beyond me. Don’t get me wrong. Design is one of THE most very important aspects of products and service. But it is left up to experts, qualified persons, deep thinking propeller hatted academics that need to be meticulous to keep people and property safe and functioning for the planned duration. So why have so much prescription in the standard? There are just so many important things to business, to customer focus, to continuous improvement that are glibly single sentenced in the standard. Why not this one? Oh well, my rant is nearly done.
The good news you can get an exclusion. The bad news if you do design, you can’t get an exclusion. So the proof is in the core business activities and what you are contracted to do. Nine out of ten times, you are doing ‘development’. And I say development, I mean modifying known models within know parameters to suit an application. If you are doing this, then I would recommend an exclusion. Anything more, then it is the full bottle and the next few weeks will either enthral or you bore you. Let’s find out together.
The seven topics we will cover in the three remaining blogs are;
Design and development planning; Design and development inputs; Design and development outputs; Design and development verification; Design and development validation; and Control of design and development changes.
And on reflection, this stuff should really only apply to 5% of all companies seeking certification. So for the rest of you, hold on tight.
The good news you can get an exclusion. The bad news if you do design, you can’t get an exclusion. So the proof is in the core business activities and what you are contracted to do. Nine out of ten times, you are doing ‘development’. And I say development, I mean modifying known models within know parameters to suit an application. If you are doing this, then I would recommend an exclusion. Anything more, then it is the full bottle and the next few weeks will either enthral or you bore you. Let’s find out together.
The seven topics we will cover in the three remaining blogs are;
Design and development planning; Design and development inputs; Design and development outputs; Design and development verification; Design and development validation; and Control of design and development changes.
And on reflection, this stuff should really only apply to 5% of all companies seeking certification. So for the rest of you, hold on tight.
Tuesday, 8 May 2012
Who is Branding Who
OK, so now you are certified. Woohoo. The band has left, the nibbles have been nibbled and the whole boardroom is festooned with your chosen certification body’s logo. Some of these logos / brands are very popular and well recognised, some are not.
So unless you are selling your product / service based solely on the recognition factor of your certification service provider (and I hope you are not), then why bother promoting them without the commensurate royalty or advertising fees. In retail, cataloguing and shelf space is a very expensive exercise, so why aren’t you charging for their right to use your space to promote their business? A little bit cynical I know, but worth pondering.
Of course it is good to use as PR and your own brand recognition to be seen as a committed quality provider. But even the most popular of the CB brands is also just a little bit misleading. Is it quality management system endorsement or is it product certification? Who knows, unless you look at the small print. Don’t trade on misconception.
Promote your certification and your CB heavily to those who need to know it most. Where possible, keep it electronic. There is nothing more expensive than having to repaint your warehouse or your 1000 strong truck fleet (Sorry 1st Fleet, your CB wasn’t the cause I hope) with a new logo because your relationship with your current provider has soured. Or even worse, because of such expenses, you are forced to remain with one that adds no value to your company.
So unless you are selling your product / service based solely on the recognition factor of your certification service provider (and I hope you are not), then why bother promoting them without the commensurate royalty or advertising fees. In retail, cataloguing and shelf space is a very expensive exercise, so why aren’t you charging for their right to use your space to promote their business? A little bit cynical I know, but worth pondering.
Of course it is good to use as PR and your own brand recognition to be seen as a committed quality provider. But even the most popular of the CB brands is also just a little bit misleading. Is it quality management system endorsement or is it product certification? Who knows, unless you look at the small print. Don’t trade on misconception.
Promote your certification and your CB heavily to those who need to know it most. Where possible, keep it electronic. There is nothing more expensive than having to repaint your warehouse or your 1000 strong truck fleet (Sorry 1st Fleet, your CB wasn’t the cause I hope) with a new logo because your relationship with your current provider has soured. Or even worse, because of such expenses, you are forced to remain with one that adds no value to your company.
Tuesday, 1 May 2012
Customer Related Processes - Part II
Second instalment. Here is the cut and paste (it is long, so persevere);
7.2.2 Review of requirements related to the product. The Company will review the requirements related to the product. This review is conducted prior to commitment to supply a product to the customer (eg. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensures that a) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, and c) the Company has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained. Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the Company before acceptance. Where product requirements are changed, the Company shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
7.2.3 Customer communication. The Company has determined and will implement effective arrangements for communicating with customers in relation to a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer complaints.
And on reflection the above is very prescriptive and self-evident. A nice simple procedure should suffice addressing each of the above elements. You don’t need a documented procedure but I would rather have one, especially around authority limits for go / no go tenders, quotes and proposals, and very much in particular concerning communications, escalations, feedback and complaints. If you intend not to use a procedure, just make sure there are ample records to demonstrate your processes are robust and of course meet the requirements of the clauses above.
7.2.2 Review of requirements related to the product. The Company will review the requirements related to the product. This review is conducted prior to commitment to supply a product to the customer (eg. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensures that a) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, and c) the Company has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained. Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the Company before acceptance. Where product requirements are changed, the Company shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
7.2.3 Customer communication. The Company has determined and will implement effective arrangements for communicating with customers in relation to a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer complaints.
And on reflection the above is very prescriptive and self-evident. A nice simple procedure should suffice addressing each of the above elements. You don’t need a documented procedure but I would rather have one, especially around authority limits for go / no go tenders, quotes and proposals, and very much in particular concerning communications, escalations, feedback and complaints. If you intend not to use a procedure, just make sure there are ample records to demonstrate your processes are robust and of course meet the requirements of the clauses above.
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