Non-conformance plan
Use this function to guide and schedule corrective or preventive actions against a reported non-conformity.
You can access this function from the Non-conformances menu or from the Action panel in a non-conformance.
You can only add (or amend) corrective or preventive actions to an action plan that has been generated from a non-conformance incident. You cannot use this function to generate a new action plan then link it with a non-conformance.
The key to implementing and executing a successful 'change' to a reported non-conformity to meet customer or regulatory requirements is in the planning. An Action plan conveys the objectives for delivering a product or a solution that is 'fit for purpose' within the context of a 'problem' or 'defect', or failure or potential failure in a design or production model, or in a service, or in a process, or in the system. An Action plan conveys the objectives of the 'corrective and preventive' process to stakeholders and to those actually involved in delivering a product or a solution.
This function supports the planning process. It brings together the components that must be met to successfully correct or prevent an incidence of non-conformance and provides a framework for adjusting the current system or operations currently in use. For example, if the corrective actions should be applied to the manufacturing process in your company this function can help plan how this will be done.
This function offers dual purpose:
- Used as a planning tool it facilitates in the consideration and identification of the components required to deliver a specific 'change'. The Planner (project manager) builds these components into an action plan that will deliver the corrective or preventive actions to address the non-conformity.
An Action plan comprises a set of 'global actions'. The Global actions outline the approach to be taken to deliver the requirements for the 'change'. Essentially they describe the 'what', 'who' and 'when' objectives from the approved scope.
The Global actions also provide the detail or specifics for delivering the approved requirements. They meet the 'how' objectives from the approved scope by providing a breakdown of all work to be completed by transaction type.
- Used as a communications tool it provides the outline and guide for making decisions.
Stakeholders can use an action plan to consider the components proposed by the project manager, and for confirming or developing the scope of the requirements.
By providing this functionality from a single location the Non-conformance plan function becomes a critical tool for managing your end to end 'corrective and preventive' processes. It categorizes the sequencing of activities and simplifies time estimations to avoid delays and potential cost overruns.
As an additional feature, this function can safeguard the delivery of an approved scope. An Action plan directly impacts the progress of a non-conformance incident through the remaining stages of the corrective or preventive cycle. A non-conformance incident, therefore, can only progress to status 'Completed' once all individual tasks (actions) on the Action plan have been accomplished. This empowers the QA manager to hold a non-conformance at status 'Being implemented' until the requirements have been delivered in full and have been approved. Once the product is corrected and approved as 'fit for purpose' the non-conformance can then be advanced to the final status of 'Closed'.
The Action plan is automatically deleted if the status of a non-conformance is reverted from status 'In planning' to status 'In review'.
For an overview of how to use this function in your particular role click on the appropriate link in the following list:
- Planner (Project manager)
- Actioner
- Stakeholder
Planners (Project managers)
At this stage in the corrective or preventive cycle of a non-conformance, the non-conformance incident has been reviewed and progressed to status 'In planning'. As the Planner (Project manager) assigned to that non-conformance the QA manager has effectively handed over control of it to you. You are now responsible for planning a successful delivery of those requirements.
Your task is to build a set of 'global actions' to eliminate the problem. Your Action plan should outline the approach to be taken to meet the approved requirements. You will use it to control or manage the corrective or preventive actions through to the conclusion or delivery of a product that is 'fit for purpose'.
To build the Global actions use the information provided on the Non-conformance as your guide. The Non-conformance is both the details of the non-conformity or problem and the requirements document. You should list the main transaction types required for the 'change' with the main tasks or actions to be accomplished, and appropriate timeframes. You can adapt the level of detail you provide to the size of the requirements, changing actions where required whilst the action is at status 'pending' and deleting actions that have not been started.
A complete Action plan should cover the key deliverables, the completion date and all components required to deliver the corrective or preventive actions, and therefore to eliminate the cause of the non-conformity or problem.
The timeframes, milestones and dates you define will provide you with an effective control mechanism in the successful delivery of the 'change'. You could baseline the change from them. One comment field per line is available to you which you could use to communicate with the assigned actioner and the stakeholders. You can also add extra information per line using a free-format text entry facility. You could use the comment and text feature, for example, to state assumptions or list constraints that might limit or affect progress or completion of that task.
Tip: Use the My non-conformances to plan filter to locate your tasks quickly and easily.
When you have completed your Global actions click Implement. This sets the status of the Action plan to 'Being implemented'. This indicates to the actioners that they can start actioning the tasks on the plan to which they have been assigned.
An Action plan at status 'Being implemented' advances the status of the non-conformance to the next stage in the corrective or preventive cycle, status 'Being implemented'. This provides visibility to the stakeholders that the framework of the Action plan has been outlined and the solution is ready for, or being implemented.
You can continue to add tasks to the plan as necessary whilst the Action plan is at status 'Being implemented'.
An Action plan is not mandatory. If you are not defining corrective or preventive actions (Global actions) click Implement then click Complete. This advances the status of the non-conformance through the next stages in the corrective or preventive cycle to status 'Completed'.
Actioners can start the tasks to which they have been assigned before you click Implement if your company policy permits this. Transaction types and actions can then be added to the plan at a later stage. This can be particularly useful where a hierarchy of processes exist within your organization. The system will block a line (an action) from being set to 'In progress' until the Action plan is at status 'Being implemented', however the line can be set when the plan is ready. Just be aware that the Start date will not then reflect the true start date for the task.
Blocking transactions
A potential consequence of a 'change' can be that the processing of transaction lines associated with a specific non-conformance must be halted, or blocked. Should this be necessary you must manually block the transaction lines affected by the corrective or preventive actions.
Manual blocking is different for the different transaction types. Purchase order lines, for example, can be closed if the supplier has not shipped the goods. Sales order lines can either be closed or the stock deallocated. You must choose the most suitable blocking method for the type of transaction.
You are advised not to reactivate a blocked transaction until the product is corrected and approved as 'fit for purpose'. This will not be until the action plan has been implemented and the non-conformance is complete.
Actioners
As an actioner you are responsible for taking ownership of and delivering a line (a task or action) in the Action plan by the specified date.
At this point in the processing of a specific non-conformance, however, you are dependent upon the planner (project manager) signaling the 'go ahead'. They will do this by setting the Action plan to status 'Being implemented'. This confirms they have outlined the framework of the Action plan and the solution is ready to be implemented.
As soon as the Action plan is at status 'Being implemented' you can start actioning the tasks (actions) to which you have been assigned.
All tasks you have been assigned to deliver will initially display the status 'Pending'. Set the Status of the line when you begin the work and again when you complete it. The Start and End dates are linked to the line Status and populated automatically when you select a value. This not only provides visibility to all stakeholders of your particular progress to date, but also to the progress of the plan overall. Take note of any comments added by the project manager in the Comment field and free-format text fields. They can add a comment per line and could highlight assumptions they have made or constraints they are aware of. The Line text flag is selected if they have entered additional comments for a specific action. Conversely, you can use these fields to add notes for yourself or to form a two-way dialogue between yourself and the Planner.
Tip: Use the My actions to implement filter to locate your outstanding tasks quickly and easily.
You can start an assigned task before a plan is set to status 'Being implemented' if your company policy permits this. The system will block you from setting the line (an action) to 'In progress' until the Action plan is at status 'Being implemented', however you can set it when the plan status is changed. Just be aware that the Start date will not then reflect the true start date for the task.
Remember to update the Action plan. Keeping the Action plan up to date provides visibility to all stakeholders of its progress.
The status of your tasks directly affects the status of the whole Action plan and ultimately delivery of the requirements. Only when every line on every plan is at status 'Completed' can the non-conformance be advanced through the remaining stages of the corrective and preventive cycle. It is imperative, therefore, that you keep your tasks up to date.
Stakeholders
As a stakeholder or member of your company's 'change board' or steering committee, you can, at any time, access an action plan. An action plan shows you how the objectives for the design or production 'change' will be met. You can use it as a mechanism for referencing and managing business risk, and potentially costs.
Whilst the majority of communication would have taken place during your scheduled meetings you can obtain specific information, when you need it, from the plan. An action plan provides visibility of proposed changes. An action plan also provides visibility of progress against that plan.
If your actioners update their statuses on a 'real time' basis the Action plan keeps you informed. You can use it when determining the costing estimates, for budgeting and, if necessary, for replanning. It is central to your accountability as a stakeholder.
Prerequisites
Refer to documentation Implementation
Screen management
The Action plans functions contains a header information section and a link to the Global actions.
The Global actions block is the corrective and preventive Action plan. This plan defines the approach to be taken to deliver corrective or preventive actions to address the reported non-conformity.
Header
Presentation
The header information provides the current status of the Action plan and key information from the reported non-conformity.
A plan status can be one of the following: 'In planning', 'Being implemented' or 'Completed'.
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Fields
The following fields are present on this tab :
Plan
| This field displays the sequence number of the non-conformance incident associated with this plan. |
| This field indicates the current stage of this plan in the corrective and preventive cycle.
In planning Being implemented Completed |
| This field displays the code and name of the Enterprise Management user that last updated this Action plan. For example, the user that last changed the status of a line in the Global actions. |
| This field displays the date this Action plan was last updated. For example, it might reflect the last date the Planner added a line (task) to the Global actions or the date a task in the Global actions was last updated. |
Non-conformance
| This field indicates at which site (location) or sites the incidence of non-conformance occurred. A non-conformance incident applies to a single site if either of the following conditions apply:
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| This field displays the sequence number of the non-conformance incident associated with this plan. |
| This field identifies the product a 'problem' or 'defect', or failure or potential failure in design or production, or process was observed and reported against. Leave blank if the non-conformance applies to a system or non-stock item such as documentation, procedure or training.
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| This field indicates which version of this product applies. Major versions might be used where there have been increased or significant changes to the original or previous version, that is the "form, fit or function" has changed. This field is not populated if the product code defined in the Product field is not version managed. |
| This field indicates which minor version of this product applies. Minor versions might be used where there have been minor features or changes in functionality, or significant fixes applied to a specific major version. This field is not populated if the product code defined in the Product field is not version managed. |
| This field identifies the subject matter expert who has the authority to categorize, prioritize, approve or reject, and monitor corrections for the reported incidence of non-conformance. The QA manager defined in this field ultimately has full control over the non-conformance incident and the progress of it through the corrective and preventive cycle. They have administrative rights to advance or reverse the non-conformance through the stages of the corrective and preventive cycle as they deem necessary. |
| This field identifies the Planner (project manager) responsible for planning the set of 'global actions' that form this corrective and preventive Action plan. They are the person responsible for planning the approach to be taken to eliminate the problem. The Planner uses this Action plan to control or manage the corrective or preventive actions through to a successful correction and approval of a product that is 'fit for purpose'. |
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Tab Global actions
Presentation
This block is the corrective and preventive Action plan. This plan defines the approach to be taken to deliver corrective or preventive actions to address the reported non-conformity.
To append or amend a line in the Global actions:
- This plan must be at status 'In planning' or 'Being implemented';
- You must be logged in as the current Planner for this non-conformance incident.
Planners (Project managers)
To build your Action plan append the main transaction types to be addressed with the tasks or actions to be accomplished. Then assign appropriate timeframes and actioners. A complete action plan should cover the key deliverables, the completion date and all components required to deliver the corrective or preventive actions to eliminate the cause of the non-conformity or 'problem'.
The actions you can include in your plan are from a predefined set of values. These have been associated for use within your particular organization with specific types of transactions. For example, if predefined, you could select that Bills of materials (BOMs) (transaction type) are disassembled (action) and that Purchase orders (transaction type) are returned to the supplier (action).
You assign the key dates and personnel to oversee delivery of each individual 'action'. You can add one comment per task. You can also add extra information per line. You could use the comment and additional line text facility, for example, to state assumptions or list constraints that you are aware of.
You can broaden the scope of your plan by including actions for transaction types associated with your organization. For example, if predefined, you could select a recommendation that customers (transaction type) must be consulted (action). By including these in your planning your action plan will be complete.
Actioners
Set the status of the line when you begin the work for your assigned task (or action) and again when you complete it. This will populate the Startand End dates for the line and provide visibility to all stakeholders of your progress.
Take note of any comments added by the project manager in the Comments and Line text fields. They could highlight assumptions the project manager has made or constraints they are aware of. The Line text flag is selected if they have entered additional comments for a specific action. Conversely, you can use these fields to add notes for yourself or to form a two-way dialogue between yourself and the Planner.
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Fields
The following fields are present on this tab :
Block number 1
| This field is selected if extra information exists for this line.
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| Use this field to identify a type of business transaction which is commonly carried out in your organization. For example, if your company returns faulty purchased goods to the supplier select the value 'Purchase orders'. To create the task you must now select an Action code that has matched, or linked the selected transaction type with a specific action (business process). For example, you could link the value 'Purchase orders' with a 'returns' action such as 'Return to supplier'. The resulting matched, or linked, business process plus transaction type is given the general term 'Action'. Each 'Action' (or task) should reflect a 'process' commonly carried out within your organization. The list of transaction types is defined in Miscellaneous table 807 - Transaction type. |
| Use this field to identify an 'Action'. 'Action' is the general term given to a business process that has been matched, or linked with a specific type of business transaction. |
| This field describes the assigned preventive or corrective 'change'. |
| Use this field to identify if this task is a corrective or preventive measure against the incidence of non-conformance. The list of action types is defined in Miscellaneous table 805 - Plan action type. |
| Use this field to define the date by which this task must be completed.
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| Use this field to identify the Enterprise Management user who must take ownership of the task or action assigned. This user will be responsible for delivering the assigned task in full by the required date. Type in or select from the Users table (table AUTILIS) the code of the Enterprise Management user who will be responsible for delivering the requirement. |
| Use this field to indicate the current stage of this planned deliverable.
Pending In progress Completed |
| Use this field to communicate information to others. Type in comments pertinent to the task (maximum 50 characters). For example, as a Planner you could use this field to highlight or warn the Actioner responsible for delivering the task of the following:
As an Actioner you could use this field to add notes for yourself or to form a two-way dialogue between yourself and the Planner.
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| This field displays the date this line (task) was started. It is set automatically when the actioner changes this task from status 'Pending' to 'In progress'. If this task is reverted from status 'In progress' to status 'Pending' the system will automatically delete the date.
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| This field displays the date this line (task) was completed. It is set automatically when the actioner changes this task from status 'In progress' (or 'Pending') to 'Completed'. If this task is reverted from status 'Completed' to status 'In progress' or 'Pending' the system will automatically delete the date.
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Action icon
Line text entry
Click Line text entry from the Actions icon to view or add extra information.
Planners (project managers): Use this facility to communicate information to others. Type in comments pertinent to the task. For example, you could use this facility to highlight or warn the actioner responsible for delivering the task of the following:
Actioners: Take note of any comments added by the Planner (project manager). They could highlight assumptions the project manager has made or constraints they are aware of. Conversely, you can use this action to add notes for yourself or to form a two-way dialogue between yourself and the Planner.
You could use this feature for two-way communication between the Planner and the actioner.
This action is available to the Planner for a line at status 'Pending' or 'In progress'; the line must be at status 'In progress' for an Actioner to use it.
Line text display
Click Line text display from the Actions icon to view information or comments pertinent to the task such as assumptions the project manager has made or constraints they are aware of.
This action is only available if the Line status flag is selected and the status of the line is set to 'Completed'.
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Specific actions
Click the Implement action when the framework of this Action plan (the Global actions) has been outlined and the solution is ready to be implemented. This will advance the status of this plan to status 'Being implemented'. This indicates to the actioners that they can start actioning the tasks on the plan to which they have been assigned and in turn provides visibility to stakeholders of the progress of the corrective and preventive Action plan.
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Error messages
In addition to the generic error messages, the following messages can appear during the entry :
Field error
The value you have entered in the field does not exist in the Miscellaneous table associated with the field. Either enter a different value or add the record you require to the Miscellaneous table (Miscellaneous table 805 - Plan action type, Miscellaneous table 806 - Actions or Miscellaneous table 807 - Transaction type).
Field error : The [xx/yy] combination is not correct
The value you have entered in the field has not been matched, or linked with the selected transaction type in the Actions (GESNCSA) function. An 'Action' is a general term for a matched, or linked business process plus transaction type.