Procedures
The absolute minimum number of documented procedures required by the standard is only 6, covering the following elements; 4.2.3 - control of documents, 4.2.4 - control of records, 8.2.2 - internal audits, 8.3 - nonconforming product, 8.5.2 - corrective action; and 8.5.3 - preventive action.
All other elements while they do not require documented procedures will require established processes and have records that can demonstrate effective controls.
Records
The minimum records required by the standard are; 4.2.3 - control of documents, 5.6.1 - management review, 6.2.2 - training, 7.1 - planning of product realisation, 7.2.2 - review of requirements related to product, 7.3 - design and development, 7.4.1 - purchasing process, 7.5.2 - validation of processes for production and service provision, 7.5.3 - identification and traceability, 7.5.4 - customer property, 7.6 - control of monitoring and measuring devices, 8.2.2 - internal audits, 8.3 - nonconforming product,
8.5.2 - corrective action; and 8.5.3 - preventive action.
So keep an open mind when designing your system and only document what your business needs to ensure customer focus and profitability.
For all things John Mason in plain English. Plain text will give you insights into quality assurance, certification, consulting and business philosophy.
Friday, 23 March 2012
Tuesday, 20 March 2012
Get the Price Right
I was taught when it comes down to selecting a product or service, base your decision on price, quality, service. Then remember that you can only ever have two of these three of these attributes. So today, let’s focus on price. No two certification providers supply their schedule of fees in the same format. Much the same way as no two consultants will provide you with a proposal in the same format.
However, a certification services provider really only has a finite number of components to their costing and therefore should be able to have a direct comparison made. Here are some of the ‘words’ used when quoting fees; application fee, administration fee, annual licence fee, additional certificate fee, gap analysis fee, stage 1 fee, stage 2 fee, document review fee, certification audit/review fee, accreditation levy, post certification / surveillance fee, triennial audit / recertification audit fee, follow up audit / nonconformance audit fee, travel time fee, travel expenses, cost recovery fees, etc.
Nearly all providers charge on a fee for service basis which normally means the provider over services. At least one, structures around fix fee, paid in advance. Only one charges for intra-metro travel, some charge intrastate, most charge interstate and international. All will charge you extra for a nonconformance or follow up audits. Most will increase their fees by CPI each year. All will review their fees just before or after each 3-year certification cycle.
The best way to evaluate them is to set up a matrix that allows multiple variations in fees and terminology. Then add weighting factors for customer service, reporting, penalty clauses, etc and then it all be just up to just how damn good they can be with their customer service and their quality management processes.
However, a certification services provider really only has a finite number of components to their costing and therefore should be able to have a direct comparison made. Here are some of the ‘words’ used when quoting fees; application fee, administration fee, annual licence fee, additional certificate fee, gap analysis fee, stage 1 fee, stage 2 fee, document review fee, certification audit/review fee, accreditation levy, post certification / surveillance fee, triennial audit / recertification audit fee, follow up audit / nonconformance audit fee, travel time fee, travel expenses, cost recovery fees, etc.
Nearly all providers charge on a fee for service basis which normally means the provider over services. At least one, structures around fix fee, paid in advance. Only one charges for intra-metro travel, some charge intrastate, most charge interstate and international. All will charge you extra for a nonconformance or follow up audits. Most will increase their fees by CPI each year. All will review their fees just before or after each 3-year certification cycle.
The best way to evaluate them is to set up a matrix that allows multiple variations in fees and terminology. Then add weighting factors for customer service, reporting, penalty clauses, etc and then it all be just up to just how damn good they can be with their customer service and their quality management processes.
Friday, 9 March 2012
Infrastructure and Work Environment
I just don’t get these clauses. Well I get the clauses, but don’t really know why they are in the standard. Well I know why, but it begs the question why don’t we have the other one million company attributes in the standard that we need for product, service conformance or even that nasty little thing called customer service??
So here is the cut and paste from the standard;
6.3 Infrastructure. A company has determined, provided and will maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable;
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).
6.4 Work environment. A company has determined and will manage the work environment needed to achieve conformity to product requirements.
Do the words, ‘a big, fat, der’ come into your mind? Some of our auditing colleagues have grabbed on to the word ‘maintain’ in the first paragraph of 6.3 to mean maintenance programs, service records etc. But have you noticed there are no requirements for process, procedure or records? So let’s assume that every facet of a company will in some impact on the quality of your product and service and that during the planning and continuous cycles, any ‘weakness’ will be identified and rectified and preventively planned for in the future. For mine, a checklist item in management review for these two aspects should get the job done.
So here is the cut and paste from the standard;
6.3 Infrastructure. A company has determined, provided and will maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable;
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).
6.4 Work environment. A company has determined and will manage the work environment needed to achieve conformity to product requirements.
Do the words, ‘a big, fat, der’ come into your mind? Some of our auditing colleagues have grabbed on to the word ‘maintain’ in the first paragraph of 6.3 to mean maintenance programs, service records etc. But have you noticed there are no requirements for process, procedure or records? So let’s assume that every facet of a company will in some impact on the quality of your product and service and that during the planning and continuous cycles, any ‘weakness’ will be identified and rectified and preventively planned for in the future. For mine, a checklist item in management review for these two aspects should get the job done.
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