Posts Tagged ‘registrar’

Too much time to document corrective actions? Consider the long term benefit!

Sunday, May 23rd, 2010

Reason # 4 in our Top Ten Countdown of quality system mistakes-

#4 – Corrective actions aren’t documented!

When conducting internal audits, we often see third party registrar reports that contain a nonconformance finding for not documenting corrective actions as stated in the company’s written procedures. The usual response is that there just isn’t enough time to document issues when they can be solved (or perceived as solved) within a short period of time. Although this may seem true on the surface, after a little investigative auditing, we often find that some of those issues that were “fixed” on the fly are coming back repeatedly either in the same area or in other areas of the business.

Although it is easy to rationalize the behavior of making simple quick process corrections without going through the formal documentation route, the end result is almost always the same. Since the issue was not documented and many other areas of the company were not aware of the problem, not to mention the solution (which may or may not be long term), the problem keeps raising its ugly head.

There is tremendous value when a corrective action is properly documented, true root cause is determined and long term solutions are communicated to all functions of the organization. These “extra steps” that can, on the surface, seem troublesome and time consuming but can actually save both time and money by reducing or eliminating repeat nonconforming issues. Please keep in mind we are not suggesting the documentation of every little operational issue that requires simple adjustment during the course of doing business. We are talking about those issues that can affect the customer and/or have an effect on internal processes.

For information on how to effectively document corrective actions, contact the experts at G3 Solutions.

Stage 1 and Stage 2 registrar audits – How does this affect your ISO 9001 plans?

Monday, June 1st, 2009

Quite often companies in the implementation phase of ISO 9001 will ask about the two stage process for registration audits. Sometimes the planning strategy for an organization will not take into account the length of time intended for this process.

The practical reason for having a period in between the stage 1 & 2 registration audits is to provide an organization with the time to make final adjustments and resolve potential nonconformances before their stage two audit.

ISO/IEC 17021:2006, 9.2.3.1.3, which provides registrars with rules and guidelines for conducting audits, states: “In determining the interval between stage 1 and stage 2 audits, consideration shall be given to the needs of the client to resolve areas of concern identified during the stage 1 audit. The certification body may also need to revise its arrangements for stage 2.”

This does not, however, negate the possibility of having back to back audits. This can be arranged with the 3rd party certification body (also referred to as a registrar) but this should be the exception and not common practice.

Management Review – Are you meeting just for ISO reasons?

Monday, April 6th, 2009

The scenario is common in many companies. Quality planning meetings are held by top management on a regular basis, usually once a month or more, with discussions of key metrics, process performance, corrective actions, along with a host of other items. Notes are taken, actions are assigned and items are followed up on during the next meeting. So the question must be asked – why do we need a separate “Management Review” meeting? Just to fulfill an ISO requirement?

This is a good question. Having an official “Management Review” meeting (sometimes done by companies only once per year) just to make sure the 3rd party registrar auditor is happy can be quite an exercise in wasting time and reinforcing some unconstructive, even negative views of having a quality system in place. Employees (many of them in the ranks of top management) begin to question the value of the process.

Don’t let this happen to your organization!

Most quality standards such as ISO 9001, ISO/TS 16949, AS9100, ISO 13485, ISO 17025 and others have the requirement of management reviewing their quality system at defined intervals to ensure it is working as a catalyst for process effectiveness and/or improvement. A perfect opportunity to fulfill this requirement can be made during those normal meetings when top management is discussing various quality issues such as production scheduling or account reviews.

One method to efficiently maximize meeting time is to break down those ISO 9001-based requirements found in clauses 5.6.2 and 5.6.3 and review those topics during different meetings. Some topics such as quality metrics and measurables should be reviewed frequently while others such as the review of the quality policy can be looked once per year or as needed. Over the span of a year, all topics can be reviewed as part of the normal planning process. Providing you have the notes and objective evidence to show that all required items were part of the meetings, you have covered the management review requirement.

Remember, the whole point of having a review of the quality management system is to effectively facilitate continual improvement – not to just to fulfill a requirement.

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