Let’s get straight into it; Your company applies suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product.
There are many ‘key’ words in the above; suitable, where applicable, as appropriate, planned and the biggy, ‘quality management system processes’. Not machinery, not inventory management, not anything other than identified, within scope quality management systems activities.
Like, internal audits, like trend analyses, like planned maintenance scheduling, like, well you get the picture. Some monitoring processes are a requirement of licence conditions, so you had best be monitoring them. Others are defined KPIs or objectives through your quality policy.
No need to go big here. No need to re-invent or develop tricky stuff. Make sure you close loop such monitoring back to your own corrective action procedures. Make sure that normal monitoring have fail-safes, hold points and the ability to concession. And if you have adequately described this in your Control of Nonconforming Product Procedure and your Corrective Action Procedure and your Preventive Action Procedure, then all you need do is ‘road-map’ it and you’re done.
Monday, 24 September 2012
Tuesday, 18 September 2012
Internal Audits
Just to set the mood. This is the most important part of the standard. May I repeat. This is the most important part of the standard. And her are the requirements.
Your company conducts internal audits at planned intervals to determine whether the quality management system; a) conforms to the planned arrangements, to the requirements of the International Standard and to the quality management system requirements established by Company Name, and b) is effectively implemented and maintained.
And it continues. An audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined. Selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process. Auditors do not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are defined in a documented procedure.
And continues. The management responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected non-conformance and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results.
Yep, a very big clause. The most important clause for any quality management system. Why? When done properly, it the communication catalyst for review, for change, for improvement. And isn’t that what quality is all about?
The key points are; planning, independence, defined criteria, there is a documented procedure, defined responsibilities, effective records, management commitment, follow up. You can do what you please with the procedure, just make sure you cover all requirements.
I recommend external training of your audit manager and your auditors. Yes, it is that important. But before you go off and get too many auditors trained, read the following pitfalls / common mistakes.
• Audits are not reviews, or management reviews, or desktop views, or stocktakes, quality assurance, etc.
• Improvement auditing before compliance auditing
• Lack of independence
• Too many auditors
• Not knowing the difference between process auditing, procedural auditing
• Complex audit plans, complex reporting, complex or unique corrective actions
• Not having a documented procedure
• Lumping, batching audits into major events
Write a procedure. Develop a plan. Train two auditors. Keep audits to less than 30 minutes. Draft simple reports. Agree on corrective actions with the right people. Record (the verb), record, record.
Your company conducts internal audits at planned intervals to determine whether the quality management system; a) conforms to the planned arrangements, to the requirements of the International Standard and to the quality management system requirements established by Company Name, and b) is effectively implemented and maintained.
And it continues. An audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined. Selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process. Auditors do not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are defined in a documented procedure.
And continues. The management responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected non-conformance and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results.
Yep, a very big clause. The most important clause for any quality management system. Why? When done properly, it the communication catalyst for review, for change, for improvement. And isn’t that what quality is all about?
The key points are; planning, independence, defined criteria, there is a documented procedure, defined responsibilities, effective records, management commitment, follow up. You can do what you please with the procedure, just make sure you cover all requirements.
I recommend external training of your audit manager and your auditors. Yes, it is that important. But before you go off and get too many auditors trained, read the following pitfalls / common mistakes.
• Audits are not reviews, or management reviews, or desktop views, or stocktakes, quality assurance, etc.
• Improvement auditing before compliance auditing
• Lack of independence
• Too many auditors
• Not knowing the difference between process auditing, procedural auditing
• Complex audit plans, complex reporting, complex or unique corrective actions
• Not having a documented procedure
• Lumping, batching audits into major events
Write a procedure. Develop a plan. Train two auditors. Keep audits to less than 30 minutes. Draft simple reports. Agree on corrective actions with the right people. Record (the verb), record, record.
Monday, 17 September 2012
Economies of Scale
About two thirds of all three standards (ISO9001, 14001 and AS4801) are practically identical. Sure there are words that differ from clause to clause, but the intent are identical. And sure some of these do have nuances (not bad for a Monday) that would like to impose a certain importance to a sub clause because ‘we at the safety fraternity need this to be highlighted!’, but they are the same.
There is a great handbook from Standards Australia (HB139:2003) that demonstrate the sameness and the differences, almost word for word. This book is so good, that they haven’t needed to republish it since the 2008 version of ISO 9001.
Now having said all this, why can’t our certification service providers pass on these economies of scale to the client? Ask them and they will blame JAS-ANZ. If they do, ask them to show you the JAS-ANZ ruling or even their own published documentation that stipulates what they can or cannot economise. Unfortunately, they are not willing to share such commercially sensitive information and mostly because it is very difficult for them to find it within their own systems.
It is far easier just to throw auditor resources at the situation, to gouge the client by double dipping, even triple dipping into the audit duration, auditor days and reporting. It is far easier to account for billing time and way to easy just to keeping piling up expenses in a very cheap and nasty exercise of squeezing out the last minutia of fees.
This is exacerbated by the huge disconnect between the auditors, the skill sets, the risk profile and the sales process. Add in the lack of incentive for auditors to suggest economies of scale and it all becomes easier for them. Expensive for you. Expensive in auditor days, fees and complexity.
The real trick is to get a skilled auditor in both technical expertise of the standards and commercial acumen. And as these people are difficult to find, your friendly certification provider will default to their easy, expensive route.
There is a great handbook from Standards Australia (HB139:2003) that demonstrate the sameness and the differences, almost word for word. This book is so good, that they haven’t needed to republish it since the 2008 version of ISO 9001.
Now having said all this, why can’t our certification service providers pass on these economies of scale to the client? Ask them and they will blame JAS-ANZ. If they do, ask them to show you the JAS-ANZ ruling or even their own published documentation that stipulates what they can or cannot economise. Unfortunately, they are not willing to share such commercially sensitive information and mostly because it is very difficult for them to find it within their own systems.
It is far easier just to throw auditor resources at the situation, to gouge the client by double dipping, even triple dipping into the audit duration, auditor days and reporting. It is far easier to account for billing time and way to easy just to keeping piling up expenses in a very cheap and nasty exercise of squeezing out the last minutia of fees.
This is exacerbated by the huge disconnect between the auditors, the skill sets, the risk profile and the sales process. Add in the lack of incentive for auditors to suggest economies of scale and it all becomes easier for them. Expensive for you. Expensive in auditor days, fees and complexity.
The real trick is to get a skilled auditor in both technical expertise of the standards and commercial acumen. And as these people are difficult to find, your friendly certification provider will default to their easy, expensive route.
Tuesday, 11 September 2012
Customer Satisfaction
Finally. So far in the standard we have typed about customer focus, customer feedback, even customer owned property. Now, just 8 clauses in, we are dealing with satisfied customers. Woohoo.
It is quite often the butt of jokes when talking about quality management systems, and in particular about certification of quality management systems, that you can be a quality company, even if your ‘quality’ is crap. Just do it consistently and certification is yours.
Well, no it can’t. Not since 2008 when the standard finally talks about the satisfication (A word?? Meant as a verb) of customers.
And so the standard says; as one of the measurements of the performance of the quality management system, Your Company monitors information relating to customer perception as to whether Your Company has met customer requirements. The methods for obtaining and using this information has been determined.
Simple really. But, not just actual satisfaction but perceived satisfaction. Did you notice there was no prescription in the above paragraphs. No mention of surveys, CRMs, etc.
Just determine the methodology and have records available to demonstrate effectiveness. For the quality management systems we design, this is always a quality objective, customer satisfaction that is. Which means targets are set, programs to achieve them are developed, resources are assigned and the results reviewed to determine effectiveness. A great PDCA cycle. Then it is up to the organisational culture of the client as to what methodologies you would use to gather the data.
Yes, surveys are a good tool. Yes, exit interviews, experience interviews, contract reviews, scheduled review meetings, social media, and so many more. Pick one. See if it fits. If not, pick another. But never stop. May I repeat this? Never stop seeking the opinions of your wonderful clients, because if they won’t tell you who will? Your competition?
It is quite often the butt of jokes when talking about quality management systems, and in particular about certification of quality management systems, that you can be a quality company, even if your ‘quality’ is crap. Just do it consistently and certification is yours.
Well, no it can’t. Not since 2008 when the standard finally talks about the satisfication (A word?? Meant as a verb) of customers.
And so the standard says; as one of the measurements of the performance of the quality management system, Your Company monitors information relating to customer perception as to whether Your Company has met customer requirements. The methods for obtaining and using this information has been determined.
Simple really. But, not just actual satisfaction but perceived satisfaction. Did you notice there was no prescription in the above paragraphs. No mention of surveys, CRMs, etc.
Just determine the methodology and have records available to demonstrate effectiveness. For the quality management systems we design, this is always a quality objective, customer satisfaction that is. Which means targets are set, programs to achieve them are developed, resources are assigned and the results reviewed to determine effectiveness. A great PDCA cycle. Then it is up to the organisational culture of the client as to what methodologies you would use to gather the data.
Yes, surveys are a good tool. Yes, exit interviews, experience interviews, contract reviews, scheduled review meetings, social media, and so many more. Pick one. See if it fits. If not, pick another. But never stop. May I repeat this? Never stop seeking the opinions of your wonderful clients, because if they won’t tell you who will? Your competition?
Monday, 3 September 2012
Quality Manuals in General
When considering the structure of your quality management system, you need to be aware of the platforms and the environments within which the resultant documentation will be presented to the end user to read (and that is a whole host of blogs in itself). From there, you get to choose whether to structure the system into manuals, discreet files, departmental portals, etc, etc. I have blogged before about manuals and what the definition of them are. But now is the time to decide on what is the best fit for you.
Is it on an intranet, internet, dare I say cloud, a protected drive or directory on a LAN? Is it in hard copy and yes, there are still cases for quality management systems to be in hard copy, And so the questions of structure goes on.
It comes down to organisational, cultural, personal choices for both the end user and the administrator as to what structure is best suited for readability, control management, version management, navigation, etc.
Do you have single documents, as single electronic files or do you aggregate all documents, including forms into a single file, structured as a manual. And yes, you guessed it, it doesn't matter.
Each choice or option comes with its own pros and cons. Each requires subtle differences in document controls, version controls and the physically of making sure hard copies are updated and available.
Just remember, that a consistent approach is more advantageous (but not mandatory) and that if there are exceptions to your rules, define them, document them.
Is it on an intranet, internet, dare I say cloud, a protected drive or directory on a LAN? Is it in hard copy and yes, there are still cases for quality management systems to be in hard copy, And so the questions of structure goes on.
It comes down to organisational, cultural, personal choices for both the end user and the administrator as to what structure is best suited for readability, control management, version management, navigation, etc.
Do you have single documents, as single electronic files or do you aggregate all documents, including forms into a single file, structured as a manual. And yes, you guessed it, it doesn't matter.
Each choice or option comes with its own pros and cons. Each requires subtle differences in document controls, version controls and the physically of making sure hard copies are updated and available.
Just remember, that a consistent approach is more advantageous (but not mandatory) and that if there are exceptions to your rules, define them, document them.
Subscribe to:
Posts (Atom)