An Opportunity for Improvement (OFI) is a pretty neat idea! It allows your ASR auditor to share with you valuable ideas that may be helpful as your organization pushes its quality management system for continual improvement.
In fact, a well-thought out Opportunity for Improvement in many cases may be of more value than a well-implemented non-conformance.
What is the definition of an OFI as listed in ASR's auditing procedure?
Observations that cannot be directly referenced to either a non-fulfillment of either the requirements of the standard and/or a requirement in the organization's system, such as a documented procedure/work instruction/process chart, documented objective, etc.; shall remain observations.
An OFI or observation is presented as informational with no response required. This observation cannot be directly referenced to the non-fulfillment of a requirement.
OFI's generally address two types of incidents –
Negative situations which are visible to the auditor, but can not be related to a requirement in the standard or an organization's documentation or activities observed by the auditor during an audit that could, if reported, enhance an organization's operating efficiency.
An OFI is simply an "opportunity" to improve your business system. It is not necessarily an item that will lead to a future non-conformance if not addressed.
OFI's in some cases come from an auditor's experience in your industry. Each auditor brings a unique perspective on business systems and can offer ideas that might augment your business system. It is optional whether you decide to follow through with the OFI.
Let us take a look at several OFI examples:
Example 1:"It appears the organization has a number of data-bases independent of each other that could be connected to improve operating efficiency. With simple computer programming adjustments, data could become more readily available and provide information quickly to personnel who need it in order to make more timely decisions".
In this case, the auditor saw information that should have been communicated to other personnel, but was not being used effectively because existing databases were not linked. A little tweaking by the company's IT department could link the databases and improve internal communications and decision-making.
Opportunity for Improvement Example 2:"Might want to consider holding Management Review meetings more frequently." And a second observation by a different auditor on the same topic -- "Might want to consider developing a better method for keeping track of any assignments made during Management Review meetings."
In the early 1990's, organizations were holding annual Management Review meetings. In recent years, organizations conducted Management Reviews on a quarterly basis or maybe even parts of the Management Review on a monthly basis. Frequent management Reviews result in creating an action list or rolling action list for the entire year that is reviewed frequently in each meeting.
In other words, Management Reviews are being used as an "action" meeting rather than a historical review. This feeds right into ISO 9001's call for "management use of data."
Opportunity for Improvement Example 3:"Might want to try a different approach regarding customer satisfaction surveys – since response has been minimal using the current approach."
Historically, response to a customer satisfaction survey yields a 1 to 5% return rate. That is a lot of hard work for a small number of responses. Many organizations have turned to the use of phone logs collecting both negative and positive comments. Whenever an employee talks to a customer and the customer offers significant comments, this information is captured on the phone log. Some organizations maintain a "proof file" for letter and e/mail comments from clients.
One organization uses the contact reports from sales personnel to record positive and negative comments. These comments are summarized for use in regularly scheduled meetings. Negative responses generate a call from technical or customer service personnel.
Another organization summarizes the positive and negative comments and posts them on a display board for employees to review.
In the definition standard (ISO 9000, clause 3.1.4), organizations should recognize the importance of capturing positive comments. "Customer complaints are a common indicator of low customer satisfaction, but their absence does not necessarily indicate high customer satisfaction"
Opportunity for Improvement Example 4:"It may be value added to consider writing corrective action requests (CARs) when processes do not meet planned results during the Team review record meeting."
Several ASR clients are using this method to document action plans when metrics, either process measures or Quality Objectives, are not meeting goals. This is a good way to ensure follow-up because it requires team thinking to identify the root cause of the problem. Additionally, the CAR method creates a well-documented action plan, and ensures some follow-up on the implementation of the action plan.
Opportunity for Improvement Example 5:"It may be value added to file your vendor visit notes in the vendor files." ISO 9001:2008 requires vendor evaluations and re-evaluation. How this is to be accomplished is not defined. An example might be notes taken during a vendor visit to your facility be included in the vendor's file. If an employee makes an on-site vendor visit their notes are saved to the vendor's file. This could be a record of an evaluation or re-evaluation as required by ISO 9001.
ASR's objective is to aid clients in driving their quality management system for continual improvement and effective results.
To that end, an OFI is just a little icing on the cake!