Last century and in a previous version of the standard, this topic was a whole sub clause. Very structured, very prescriptive, but oddly useful.
Now you get one paragraph. However, it is one of my favourite sub sub clauses as it demonstrates just how the standard can be useful and ‘guide-like’ without the boring, over complicated qualspeak bits. Unfortunately, it’s last sentence will trip some up or be seen to be a duplication but as always, remember, it is the intent that matters.
So here is the requirement. Your Company Name preserves the conformity of product during internal processing and delivery to the intended destination. This preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product.
Quite simple. No requirement for a procedure. No requirement for records. Just a requirement that processes are in place to meet your needs and those of your customer when it comes to making sure your product / service meet expectations concerning the right item, protection in transit, condition on arrival, readiness for use and shelf life.
It also makes you consider, which I think is a little obvious if you are doing the rest, that you have to apply the same controls to the product at all stages of receipt, processing and delivery and that the same applies to all materials and components of the final product / service as well.
When it comes to designing systems, make sure you are doing this stuff, record it as an internal quality audit and or split up the requirements into other documented procedures as needed and then make sure your ‘road map’ keeps a track of it.
Tuesday, 28 August 2012
Tuesday, 21 August 2012
Customer Property
So what is customer product? It could be perfume samples in a magazine, coil aluminium for painting, your favourite photo for framing, soil samples for analysis, etc.
The standard implies you wouldn’t know how to control such things if in fact you did control such things as part of your product / service offerings. It is a throwback to the manufacturing origins of the standard. However, it is very important if you in fact do manage materials, products, records, etc on behalf of your customer, especially if they are to be incorporated into the final product / service.
My thinking is that if you do (and I would say almost a whole 1% of you might!), that you in fact you would already be doing what the standard requires.
So let me get down off my soap box and look at these requirements. Your company exercises care with customer property while it is under your control or being used by you. Your company identifies, verifies, protects and safeguards customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, it is reported to the customer and records maintained.
Just break it down into the components and describe them. Yes, I would draft a procedure or at least a work instruction to manage these. Make sure such processes are married to your control of nonconformance processes and as a best practice, treat all such items as you would any other inventory / bill of material item to ensure the integrity of the controls.
The standard implies you wouldn’t know how to control such things if in fact you did control such things as part of your product / service offerings. It is a throwback to the manufacturing origins of the standard. However, it is very important if you in fact do manage materials, products, records, etc on behalf of your customer, especially if they are to be incorporated into the final product / service.
My thinking is that if you do (and I would say almost a whole 1% of you might!), that you in fact you would already be doing what the standard requires.
So let me get down off my soap box and look at these requirements. Your company exercises care with customer property while it is under your control or being used by you. Your company identifies, verifies, protects and safeguards customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, it is reported to the customer and records maintained.
Just break it down into the components and describe them. Yes, I would draft a procedure or at least a work instruction to manage these. Make sure such processes are married to your control of nonconformance processes and as a best practice, treat all such items as you would any other inventory / bill of material item to ensure the integrity of the controls.
Monday, 20 August 2012
Use Your Consultant
What is the role your consultant can play in the certification process? The answer is very situational and highly dependent on your resource needs.
In the ‘before’ stage, ask for help in the selection process. Determine how many you should approach, who to target, are there industry specialists, price expectations, FTEs, are there any CB specific quirks and so on. A good consultant will also have a fee comparison tool to help with the process. Get them involved with the planning, document review and stage 1 reviews of the certification process. At least one of the major certifiers has an exhaustive precertification process that your consultant can complete on your behalf.
In the ‘during’ stage, their involvement will be dependent on their scope of work. Make sure you have agreed what that scop is and to what extent they will be visible to the certification provider. Once that is done, let the provider know. Your consultant will advise you on timing, reporting, corrective actions requirements of the specific certifier. They should also know the proposed auditor and advise accordingly. If they don’t, they should have the resources to ensure you are getting the most appropriate person for your needs. The visibility of your consultant during the audits will depend on whether they are contracted to do any of the actual work. If they are not, they really should only be present as an observer or a resource as needed. They should never get involved in the face to face process or the determination of findings unless asked to. They should be present at the entry and exit meetings, again to observe and participate as requested.
After the event, your consultant can help with the planning and structure of the remedial actions needed for any findings. They will advise on the format of the correspondence and reporting needed. And if within their scope of work, provide the documentation for you.
Just remember, let you certifier know you have a consultant in support and as needed, let them know to what extent. It is far better they know well in advance e then to be surprised on the day.
In the ‘before’ stage, ask for help in the selection process. Determine how many you should approach, who to target, are there industry specialists, price expectations, FTEs, are there any CB specific quirks and so on. A good consultant will also have a fee comparison tool to help with the process. Get them involved with the planning, document review and stage 1 reviews of the certification process. At least one of the major certifiers has an exhaustive precertification process that your consultant can complete on your behalf.
In the ‘during’ stage, their involvement will be dependent on their scope of work. Make sure you have agreed what that scop is and to what extent they will be visible to the certification provider. Once that is done, let the provider know. Your consultant will advise you on timing, reporting, corrective actions requirements of the specific certifier. They should also know the proposed auditor and advise accordingly. If they don’t, they should have the resources to ensure you are getting the most appropriate person for your needs. The visibility of your consultant during the audits will depend on whether they are contracted to do any of the actual work. If they are not, they really should only be present as an observer or a resource as needed. They should never get involved in the face to face process or the determination of findings unless asked to. They should be present at the entry and exit meetings, again to observe and participate as requested.
After the event, your consultant can help with the planning and structure of the remedial actions needed for any findings. They will advise on the format of the correspondence and reporting needed. And if within their scope of work, provide the documentation for you.
Just remember, let you certifier know you have a consultant in support and as needed, let them know to what extent. It is far better they know well in advance e then to be surprised on the day.
Tuesday, 14 August 2012
Product Identification and Traceability
A really interesting sub clause. Finally I hear you read. Well it is super interesting if it is part of your contractual agreements. If not, it will be just another ho hum. The standard wants you to consider the following. And when I say consider, I mean have a response in a quality manual, have operational procedures if they are applicable or at least have a review point, say annually in management review or as part of planning for realisation reviews.
So here goes. 7.5.3 Identification and traceability; where appropriate, my company name identifies the product by suitable means throughout product realisation. My company name identifies the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, my company name controls and records the unique identification of the product.
I know, I know. Too easy. Well as always it is a bit ‘horses for courses’. Nowhere does it say you have to have a procedure. It doesn’t even need to have a process. It doesn’t even need to have records (unless of course you do require traceability)! So why is it even mentioned at all? I don’t know, but let’s have a crack.
Identification can be by name, number, location, colour, picture, barcode, any unique qualifier that stops inadvertent misidentification. The same rules apply for the status of a product or service. Can it be readily examined and determined if it pass, fail, hold, concession, reject, etc.
The only really tricky paragraph is that ‘when it is a requirement’, you need to keep records of components, testing, use-by, delivery and even recycling for life cycle requirements. If there is a need for this, there is much review, much operational controlling, much complexity which at the end of the day will be determined by your risk exposure of the product or services.
So here goes. 7.5.3 Identification and traceability; where appropriate, my company name identifies the product by suitable means throughout product realisation. My company name identifies the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, my company name controls and records the unique identification of the product.
I know, I know. Too easy. Well as always it is a bit ‘horses for courses’. Nowhere does it say you have to have a procedure. It doesn’t even need to have a process. It doesn’t even need to have records (unless of course you do require traceability)! So why is it even mentioned at all? I don’t know, but let’s have a crack.
Identification can be by name, number, location, colour, picture, barcode, any unique qualifier that stops inadvertent misidentification. The same rules apply for the status of a product or service. Can it be readily examined and determined if it pass, fail, hold, concession, reject, etc.
The only really tricky paragraph is that ‘when it is a requirement’, you need to keep records of components, testing, use-by, delivery and even recycling for life cycle requirements. If there is a need for this, there is much review, much operational controlling, much complexity which at the end of the day will be determined by your risk exposure of the product or services.
Tuesday, 7 August 2012
Validation of production and service provision
Last century, this was called ‘special processes’. How unscientific is that? Well good old ISO thought so too and now it has the fancy title. The standard says; 7.5.2 Validation of processes for production and service provision. Company Name validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation demonstrates the ability of these processes to achieve planned results. Company Name has established arrangements for these processes including, as applicable; a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records, and e) re-validation.
My head hurts. The intent is that If you make stuff and the only way of testing it or ensuring that it meets specification is to do destructive testing, then put in the above requirements. I don’t think I have ever typed this but ‘DER’ and I capitalised. I don’t mean to trivialise this. It is a fundamental set of criteria for any manufacturer or service delivery. In my twenty plus years of consulting, even when I have come across a potential client who doesn’t even know how to spell quality, have these measures in place. No really. There are not too many businesses in existence that want to make bad product or deliver bad service. So they don’t. They may not know the quality speak behind the above requirements but they sure know how and why.
So when you get to this part of your quality management system development, use the requirements as a guideline, identify how you already do these things, document them if it is of benefit, point to records that demonstrate your process and move on to the next clause.
OK, OK. I can hear the moans. Here is a simple example. Your company supplies two pieces of steel welded together in a bracket. No protective coating. Weld strength of 150 kpa. There are approximately 1,097, 123 ways of describing this process to ensure the specification is met. Here are just a few. Bill of Material, drawing, sample plan for destructive testing for weld failure, purchase orders, material specifications for metal and welding rods, non-destructive testing of all welds, prototype evaluations, test jigs for squareness, thickness, width, standard operating procedure for assembly and welding, welding ticket of operator, quarantine area, retesting procedures, concessions processes and so on.
Try a little risk management analysis. Try communication with your suppliers and customers. Have pride in your workmanship and get on with it.
My head hurts. The intent is that If you make stuff and the only way of testing it or ensuring that it meets specification is to do destructive testing, then put in the above requirements. I don’t think I have ever typed this but ‘DER’ and I capitalised. I don’t mean to trivialise this. It is a fundamental set of criteria for any manufacturer or service delivery. In my twenty plus years of consulting, even when I have come across a potential client who doesn’t even know how to spell quality, have these measures in place. No really. There are not too many businesses in existence that want to make bad product or deliver bad service. So they don’t. They may not know the quality speak behind the above requirements but they sure know how and why.
So when you get to this part of your quality management system development, use the requirements as a guideline, identify how you already do these things, document them if it is of benefit, point to records that demonstrate your process and move on to the next clause.
OK, OK. I can hear the moans. Here is a simple example. Your company supplies two pieces of steel welded together in a bracket. No protective coating. Weld strength of 150 kpa. There are approximately 1,097, 123 ways of describing this process to ensure the specification is met. Here are just a few. Bill of Material, drawing, sample plan for destructive testing for weld failure, purchase orders, material specifications for metal and welding rods, non-destructive testing of all welds, prototype evaluations, test jigs for squareness, thickness, width, standard operating procedure for assembly and welding, welding ticket of operator, quarantine area, retesting procedures, concessions processes and so on.
Try a little risk management analysis. Try communication with your suppliers and customers. Have pride in your workmanship and get on with it.
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