Wednesday, February 18, 2009

Stress free internal audits?

Here are some tips and tricks for stress free internal quality system audits:

Tip No: 1

It really comes down to the old Boy Scout motto "BE PREPARED".

Have you added the dates of all your proposed internal and external audits to a calendar / schedule? Having this ready for the auditors gives them confidence that you are maintaining your quality system.

Tip No: 2

Make sure that for each date scheduled you detail the scope of the audit.

  • Which processes are you planning to audit?
  • Are there associated work instructions, forms you would expect to review?
  • Have you identified the process owners or auditees you will need to contact?
Tip No: 3

Prepare your audit checklist well ahead of time. There are two methods I recommend:
  • Mark-up photocopies of each procedure being audited - add questions, highlight forms / records you would expect to witness
  • If you use a generic Audit Checklist then review it and ensure its continuing validity, add further questions and highlight forms / records you would expect to witness
Tip No: 4

Contact the auditee at least three working days before the scheduled dates and confirm availability / times.

Tip No: 5

Before undertaking your audit, check previous audit records for any outstanding audit findings - find out why these action items have not been "closed out".

Tip No: 6

Put the auditee at ease right from the start of the "opening meeting" - introduce yourself, explain that you are auditing the system not the personnel. Inform the auditee how any areas of non-compliance will be documented and raised in the system. Reinforce the message of continual improvement.

Tip No: 7

Make sure that you record details of all documents and records shown to you during the audit. Record dates, part numbers, order numbers, customer names - this "objective evidence" may need to be checked by your External Auditors. Make sure it is legible.

Tip No: 8

Prepare your Audit Report as soon as possible after completion of the audit. The longer you leave it the more detail gets lost / forgotten.

Follow the Customer Order to Quality

When implementing a new ISO9001 Quality Management System, it is sometimes difficult to know where to begin. A common question is 'which procedures do I need to document?". Here's a way to help you find out which procedures your company needs to control to ensure quality, and how much to document.

ISO 9001 has six mandatory procedures which you must document. Beyond those, you get to decide what other documents you need for effective planning, operation and control of your processes. You get to decide. But how?

The focus of ISO 9001:2000 is on satisfying the customer. For most successful businesses, this is the focus regardless of their position on ISO9001. When a customer has a satisfying customer experience, they will come back, and maybe even recommend you to someone else. The whole customer experience is important. It is not only the product they receive but also the service you provide.

Using a process approach to Quality Management is one of the eight quality management principles of ISO 9001:2000, so let's use that approach to find the procedures we need to control and possibly to document. The process we want to analyse first is the one that most directly affects the customer.

We'll follow a customer order from start to finish to reveal all the processes that impact on the quality of your product and customer service. On the way we'll see how all those processes fit together, which gives you a process map almost for free.

The most basic customer experience begins with placing an order and finishes on delivery. If the product has an after market service requirement, then the service you provide will include your returns and/or service procedures. A less obvious part of the customer experience happens before the order is placed - it is how they find out about your product.

Let's go through a simple example where a customer first finds out about ACME Pty Ltd's products and makes some enquiries before placing an order.

  • Initial enquiry (phone, email, visit to website) and follow up with a quote (what information is recorded / how is pricing formulated / what forms are used?).
  • Customer order received (phone, fax, email...)
  • Record the order - on a form, or in database or software package?
  • Review the order and compare to the original quote (if any). Resolve and document any ambiguities or differences you find with the customer, so that you are sure you understand what the customer really wants. You should also check that you have the resources (material and human) to fulfill the order within the customer's expected time frame. This may be as simple as checking inventory or as complex as conducting a planning meeting about the design and manufacturing requirements. Any meeting minutes will be an important record to keep.
  • Have you evaluated suppliers to check on their performance - do you measure on-time delivery, pricing, conformance to specifications etc:
  • Print out a sales order or a work order. Does someone need to sign off on the order? Perhaps only for large ones.
  • Is there a design process? (Separate procedure generally required.)
  • How do you control / plan your manufacturing or service delivery processes. Do you have Work Instructions / Test Plans? How do you schedule jobs?
  • How do you control measuring & test equipment - usually best to start with a list of assets, number and register them. If they need calibration, testing or tagging for electrical safety how are these processes controlled? Who is responsible?
  • Do you simply distribute goods? Picking and packing might be a separate procedure or included in this one. What happens to partial orders and back orders?
  • This part of the process leads us to procedures you might need related to acquiring and managing the goods in the warehouse - purchasing, receiving goods, evaluating and managing suppliers, inventory control and storage.
  • Despatch goods (any records? e.g. a packing slip, a tracking number)
  • Invoicing (at what stage do you invoice the customer?) Do you use an accounting software package?
  • How you you measure customer satisfaction?
  • No doubt there's some training going on so you'll have a training procedure that will include keeping training records.
That's most of the procedures you'll need. You have to evaluate your own processes to decide which ones are complex and need to be written down in a documented procedure, and which ones are simple and can be performed consistently by a competent person (i.e. sufficiently trained). You will need to periodically assess the processes to make sure that what you think is happening is really happening - that's the purpose of the internal audit process.

Why use a web-based quality system?

My observation is that small / medium companies across Australia struggle to maintain paper-based quality systems. Are web-based quality systems a viable option?

I recently visited a medium sized metal fabricator who had requested help to regain certification to ISO9001:2000. The organisation had originally been accredited to ISO9001: 1994 but had let their certificate lapse around eight years ago. After a change of ownership and an injection of new employees the company was now keen to explore the opportunities of building a better business using ISO9001 as a platform for continual improvement.

I asked them why their quality system lapsed. They offered two main reasons:

  1. The management representative had left the company
  2. There were too many forms to be filled out and filed ... "we just lost track of things"
My thoughts on this are........
  • Why was it only the management representative who maintained the quality system ... isn't quality assurance meant to be everyone's responsibility?
  • quality assurance was not a "core" process of the organisation and was inadequately resourced
When we developed Teams@Work we set out to address the above problem areas.

Our quality system modules address core elements of the ISO 9001 standard and require very little in the way of additional procedural documentation. Links to our own "knowledge-base" provide guides to the development of additional system procedures, reducing the need to seek out external assistance!

Built in "work-flow" options guide users and create quality records easily.

The Calendar module allows scheduling of events eg. training, calibrations, meetings - Teams@Work also allows this calendar to be synchronised with MS Outlook - so you never loose track of important schedules.

Because Teams@Work is a hosted quality system - there are no software installations and no need for expensive IT support.

So, are web-based quality systems a viable option? YES, indeed they are.......

PS. External Auditors like them too..........