Procedure management is extremely important in any business. Procedures help direct employees on the how and why of task completion. In addition, they can provide evidence that an organization is compliant with legal regulations and contractual requirements. For this reason, having a proper procedure management system is a must for all businesses.
When it comes to procedures, there are a few things that auditors will look for first. For example, auditors will verify that a procedure was put through the proper approval process. Also, auditors will look to see if a system is in place to objectively review the procedure. In order for businesses to answer these questions, proper documentation must be gathered.
One of the most difficult things about procedure management is keeping track of documentation. Since there are many ways that employees correspond with one another, there are many documents that may surface in the process of developing and maintaining a procedure.
For example, while email correspondence may be available for one procedure, physical or paper documents may be available for another. Because of this, many companies choose to rely on QMS software to keep track of all the documents related to the procedure management process. The use of an integrated document management system streamlines the corresponding auditing process.
Web-based software applications have the added benefit of providing the ability and store procedures in a convenient location. This streamlines the audit process and ensures that procedures are accessible to team members during operations.
To learn more about Accupoint Software’s comprehensive procedures management solution, please contact us to arrange a platform demonstration.
Last week we continued our discussion on more aspects of a great management of change program. In Part 1 & 2 of our overview, we explored the actions that precipitate making the change. Today, we will discuss the implementation of the change, as well as required follow-up actions.
First, we will want to execute any pre-implementation changes and corresponding mitigation efforts that were identified. Subsequent to the implementation we will want to perform any post-implementation tasks that are required. Example would include updating procedures or modifying training materials to address the change.
Next, we need to confirm the effectiveness of the change. Once the change has been implemented it is important to make sure that the change does what it was intended to do. Sometimes organizations experience undesirable results. When this happens, we must determine if the system should be restored to the old model, or develop a new MOC to address the unintended results.
Finally, we need to follow-up and confirm the success of our mitigation efforts. This ensures that the new system will not produce any unseen difficulties for the organization. Also, we need to verify that the change is going to leave the system running smoothly and safely. Once all of these steps have been completed in their entirety, then the change can be closed.
After closure, we still have one final but critical step remaining. We must perform surveillance audits to confirm the changes were carried out consistently and the system is being used as intended. Comprehensive process audits are a great way to determine implementation results. Randomly selecting a few processes related to the change and auditing them is a good way to achieve this. It is important to remember that audits should be performed at periodic intervals. The frequency of audits depends on several factors, but should be scheduled in a manner that guarantees the sustainability of the change.
For more information on how Accupoint Software can help streamline your MOC program, contact us today.
Last week we talked about three crucial aspects of a great Management of Change (MOC) program. Those areas were the specificity and detail in the change requests, followed by risk and reward analysis, and the proper selection of a MOC evaluation team. This week we’re going to touch base on a few more important parts to a fully functional MOC program.
The API Spec Q2 requirements take a risk-based approach to quality management. When making changes, risks must be identified and measured by level of acceptability. Risks that are deemed unacceptable must be paired with mitigation plans. These plans are then designated to be carried out before, during, or after the implementation process. The purpose of the mitigation plans is to help bring the risk down to an acceptable level.
The next area we will address deals with the approval aspect of MOC. Many organizations get into trouble in this area, confusing the need for approval with the need to inform. It’s important to note that every change doesn’t have to have the same approver. A great MOC program should have an approval matrix describing who needs to approve which type of decisions, as well as a list of people who “must be informed”. If your organization gets these steps right, the approval process will be quick and painless.
This leads us to the communication section nicely. As stated before, there are those who need to “approve” and those who “must be informed”. We need to track our communication efforts with respect to the MOC. In other words, any message and corresponding response must be documented. The person responsible for sending the message is also responsible for getting a confirmation from the recipient. This means after the change is communicated, a receipt confirmation should be requested. Also, it is important to make it clear to your organization that an email response should be expected from the recipient. Simply flagging it as “Request a Read Receipt” isn’t going to get the job done. Once the recipient has responded, stating that they have received the message and understand the information, then the responsibility shifts to them to carry out the appropriate action.
Be sure to check back next week for part 3 of our overview of Management of Change. For more information on how Accupoint Software can help streamline your MOC program, contact us today.
It has come to our attention that many organizations continue to struggle with the implementation of an effective management of change (MOC) program. To that end, we are presenting a three-part overview outlining the fundamentals of a best in class MOC program.
The first aspect of MOC is the actual change request. What change needs to be made? What are the individual specs for the materials needed? What plans and documents need to be included in the change request to fully communicate what is needed? If you can’t clearly communicate what it is that needs to be changed, then the change can’t be implemented properly.
The next aspect of MOC that needs addressed is the reward of the change. Why am I even making this change? Each change should be fully connected to satisfying a business objective. Again, specificity is important in addressing these concerns. The reward needs to clearly satisfy a business goal. If it does not, why even bother taking the risk?
Possibly the most important foundation of the MOC program is the evaluation team. The MOC evaluation team is responsible for the objective evaluation of the requests. Members should represent different areas of expertise throughout the organization, with different experiences under their belt. There shouldn’t be any aspect of a request that the team can’t properly address and evaluate. Team members should be respected among their peers, and confident enough to speak up when they have concerns. If these criteria are used, your organization will select a MOC evaluation team that can handle any challenge put in front of them.
Check back next week, for part 2 of our overview on Management of Change. In the meantime, please contact us for more information on how Accupoint Software can help streamline your MOC program, today.
Many service supply organizations are using internal audits as a method to improve operations and impact their bottom line. In addition to being required by API Spec Q2, an effective audit program will highlight potential problems areas, identify failure points, and determine the effectiveness of controls.
Internal auditing provides the mechanism that organizations use to examine business processes and evaluate compliance with both internal and external requirements. Successful auditing incorporates best practices and other tools to provide maximum impact. To that end, we have outlined five useful tips to help advance your next internal quality audit.
1. Strong Attention to Detail
It is important for internal auditors to note and document evidence throughout the auditing process. These notes are used later to analyze events and reconstruct specific situations. This does not mean that auditors should focus on tiny, unimportant details through nit-picking, but rather components that are a part of a bigger issue that can be addressed.
2. Friendly Attitude
Stress levels are already high when employees are dealing with an audit. If an internal auditor is aggressive, hostile, or difficult to deal with, employers often minimally engage and will not share as much. If an internal auditor presents with a friendly attitude and is open, they will be more likely to get feedback. The last thing an auditor wants to do is put an employee on the defensive or make them feel ill at ease.
3. Reporting Supported by Checklists
Internal auditors use checklists to balance reporting and should ensure that they are clean and support numerical values and ratings. These checklists enable companies to report on growth as well as challenges that exist across various departments. These reports are essential and allow businesses to assess whether their improvement efforts are working, and what training is needed to reach their goals.
4. Generation of Auditing Teams
Internal auditing teams can be very successful, especially with all the documentation that goes into completing an audit the right way. While a single auditor would be responsible for actively listening while documenting their findings, a team can allocate responsibilities to various areas such as recording, listening, and documenting. This way, all team members can collaborate to ensure no information is overlooked.
5. Looking at the Whole Picture
When an internal audit is taking place, the auditor or team should be able to look at the picture as a whole, incorporating current situations as well as past audit results. Focus should take place on past issues to determine whether they have been corrected and closed before reassessments take place in the same area. This is a delicate balance that will prove most effective and time efficient.
For more information on how Accupoint Software can help streamline your internal auditing program, please contact us today.