15th Century E-mail
Submitted by ttact team on June 17, 2008 - 17:14.When people in organizations fail to carry out tasks to the same level of competency as others, why does that happen? The reasons can be complex, and can depend on an individual’s ability to learn.
One thing that we should consider, however, is whether we, as Management, have made correct assumptions about existing skill sets, and the degree to which they need to be enhanced to make full use of any new procedures or technologies that we introduce.
Here’s what might happen when we give a guy from the 15th Century a crash course in how to use e-mail, without considering what he’s used to doing with respect to effectively communicating, and without ensuring that he has a good understanding of its key characteristics and benefits in today’s environment.
Some Surprises Aren’t Nice
Submitted by ttact team on June 17, 2008 - 17:06.One of the key aims of an internal auditor is to ensure that any observations or recommendations that are written into the final report are agreed to by the parties that were audited. That’s not to say that you will always be able to achieve this, or that you should leave out any observation that is likely to be disputed, but we should recognise that there are different ways of documenting the same issue, and some of these ways will lead directly to creative actions to correct the situation, and others will lead to hours of debate around the validity of the observation itself.
We suggest that there are two critical points in the auditing process to ensure that you do all you can to achieve a positive response to your final report.
The first is that if you have identified a potential non-conformance, you should be clear about this with the person being audited. Explain why you think there may be an issue, and give them an opportunity to respond and give any further explanations. Also consider that other people in the company may be better placed to respond to your concerns because they have a better knowledge of the issue. If, having given every opportunity to explain, you are still of the opinion that a non-conformance exists, be precise about the nature of the issue and document all relevant details. Share what you have written with the person being audited and ask for assurance of the factual accuracy of your statement.
The second key stage is to share the information during any feedback sessions with Management. These can take place during daily ‘wrap up’ sessions, or at the closing meeting of the audit. Here, it is critical that you share with the group being audited the precise wording that you intend to use in the final report. This gives the opportunity for any factual errors to be resolved, and also for any requested wording changes to be considered.
Taking these steps will ensure that there are no surprises in the final report, and increase the likelihood that it will be accepted and worked on constructively.
Binoculars are Useful, Right?
Submitted by ttact team on May 14, 2008 - 14:42.Successful businesses continually look for ways to improve, and applying relevant tools can be beneficial. There are numerous tools that individuals and organizations may use at different levels and functions in the company, and for different purposes. These include, for example, the Balanced Scorecard, Failure Mode and Effect Analysis (FMEA), Porter’s Model of Competitive Rivalry and use of Statistical Techniques.
However, not all tools are appropriate for use in all organizations and all situations, and before deploying any tool an evaluation should be made to determine the likelihood that the use of it is likely to enhance the probability of achieving an improved outcome.
We should recognise that sometimes use of a tool that has been instrumental in bringing about a desired outcome in one situation, can be ineffective when applied in a different set of circumstances.
Here’s an example of where some enterprising guys have used a tool that’s designed to help us see things more clearly in a way that has had the opposite effect.
The Regulations Make Sense
Submitted by ttact team on May 14, 2008 - 11:14.Looking to improve your compliance profile? This is an obvious point, but sometimes the most obvious points are the ones that are most overlooked. Make sure that you understand and refer to the details of the relevant section of the regulations. Most regulations are there because they make sense.
For example, with respect to CAPA management, the FDA QSRs spell out the expectations, and when you think about it, they are very logical with respect to providing a route to achieving the intended outcome (effective corrective or preventive action).
Use the regulation to derive your own, detailed procedure, and then be able to show that you adhere to this procedure in practice.
There should be demonstrable linkages from the requirements of the Regulations to your Organization’s Procedure to the actual day to day practices in place. Not only will this improve your compliance profile- it will help you to be effective.