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A key element of the control plan is the response plan. It tells the process operators what to do when the process begins to deviate from the parameters laid out in the control plan.
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Quick reference
Response Plan
A key element of the control plan is the response plan. It tells the process operators what to do when the process begins to deviate from the parameters laid out in the control plan.
When to use
The response plan is a portion of a control plan. When the control plan is prepared in the Control phase for release with the implementation of the new process, the response plan must be a part of it.
Instructions
The response plan is the third part of a control plan. The first two are the process documentation and the monitoring plan that explains what is to be measured, the target and limits, the responsibility for measurement, and the process for collecting the measurement information and recording the data. The response plan provides guidance to the operator on what to do when the data indicates that action is needed.
There are five types of responses. A typical response plan will contain a combination of these, using the appropriate response based upon the severity of the characteristic and the nature of the non-conformance. The five approaches are:
- Increased monitoring: This approach continues the process but with additional oversight. This is appropriate when alarm thresholds have been reached.
- Manual override: This approach is used for automated processes. The automation is stopped and the process is run manually in order to exert a little more caution.
- Stop, correct, and resume: This approach is used when the process failure is clearly identified and understood – such as maintenance and calibration failures. The operator follows the corrective action procedure and restarts the process.
- Follow special instructions: When out of control parameters have been identified, follow instructions that were put in place for that condition.
- Stop and escalate: When out of control parameters have been identified and there are no special instructions, stop the process and escalate it to the experts.
Hints & tips
- Create a response for every measure and out of control condition. You don’t want the operators to guess what to do. Either they will do nothing or will start to tamper with the process and possibly make things worse.
- If using the “escalate” option, the subject matter experts need to respond quickly or the process management will likely override and ignore the control plan.
- 00:05 Hi, I'm Ray Sheen, I've saved one aspect of the control plan for it's own special
- 00:09 module, and that's because it is so important to the success of the project.
- 00:13 That's the Response Plan.
- 00:17 And just to be clear this is a subset of the overall process control plan.
- 00:21 So this is what to do when something unusual, abnormal, or
- 00:25 just playing wrong happens.
- 00:27 For starters the response plan let's the process operators know which input and
- 00:32 outputs are critical and which are not.
- 00:34 Based upon the type of response and the nature of the response.
- 00:37 The operators will have a sense of what is most important.
- 00:41 When a defect is detected and that could be an output defect or an input defect,
- 00:45 the response plan tells the operators and managers what to do.
- 00:49 First, what to do with respect to notifying the customer of the process, and
- 00:54 second, what is to be done within the process both are important.
- 00:58 In some cases, the Response Plan will prescribe a response
- 01:02 even though a defect has not occurred yet.
- 01:04 This normally happens when a process is starting to degrade.
- 01:08 For instance, a run chart on an input may indicate the presence of a special cause
- 01:13 variation with the shift in the input value.
- 01:16 The magnitude of the shift may not be enough to create a defect of output, but
- 01:20 the fact that a special cause variation has been detected is an indication that
- 01:24 the process is degrading and the response plan will likely give direction
- 01:29 to the operator as to what they should do.
- 01:31 Sometimes, that process is directed to do something that is not part of the standard
- 01:35 procedure.
- 01:36 There is a custom order or there is a special case that must be run.
- 01:41 Response plan provides directions to the operator as to how they should respond to
- 01:45 the special request or unusual situation.
- 01:47 It isn't that this is necessarily a bad problem it's just different from
- 01:51 the normal process and therefore requires special attention.
- 01:55 So let's review the different types of responses.
- 01:58 There're a number of factors that should be considered when determining what
- 02:01 are the appropriate response should be.
- 02:04 These factors include the characteristics to the process, the process parameters
- 02:08 the magnitude of the out of control or unusual situation, and the breadth and
- 02:13 depth of information that is needed to be able to respond to the situation.
- 02:17 One type of response is to increase monitoring of the parameter in question.
- 02:22 In this case, the process is continued, but with extra oversight.
- 02:27 There maybe increased testing or increased frequency of sampling.
- 02:30 This is often done if alarm limits are reached on a parameter.
- 02:34 The output is not yet out of specification but is getting close.
- 02:39 Another response is the manual override.
- 02:41 This is often used with automated equipment that has identified a possible
- 02:46 defector error. An operator or inspector or manager reviews the defect and
- 02:50 determines if it is a valid defect or if the item can be continued in the process.
- 02:55 I often find this approach used when a process has to handle custom orders or
- 02:59 custom items.
- 03:00 There's no way for an automation to know all the possible options of a custom job.
- 03:05 So, the automation flags it as a possible error and someone must respond to it and
- 03:09 make a determination.
- 03:11 The third one is probably the easiest to understand: stop, correct and resume.
- 03:16 This is often the response used for set-up error or a manual assembly error.
- 03:20 This is also the approach normally used for
- 03:22 items discussed in the troubleshooting guide for the operator.
- 03:25 When they have a specific type of problem they should stop,
- 03:28 take a specific corrective action, and then they can resume the process.
- 03:32 It's a great approach, but it requires the process designers to have
- 03:36 already identify that as a possible defect.
- 03:39 It doesn't work well for brand new problems.
- 03:42 The fourth response is almost a variation on the third response.
- 03:46 Again, the operator stops work but
- 03:48 now they begin to follow some special procedures.
- 03:51 This is normally used if the problem or
- 03:53 error is not a quick fix that can be easily corrected and the process resumed.
- 03:58 This is often used with items that are very expensive or
- 04:02 that are very sensitive to external stakeholders.
- 04:05 In these cases, we normally don't wanna throw something away and start over, so
- 04:09 there are special instructions for what to do in this special situation.
- 04:14 The fifth response approach is a fallback approach when
- 04:16 you've not been able to prepare one of the other four.
- 04:19 The operator's response is to stop and ask for help.
- 04:22 Bring it to the experts, and let them determine what is happening.
- 04:26 And I recommend this response for new process introductions or
- 04:29 critical process parameters until the process can become stable.
- 04:34 When there is a problem,
- 04:35 I want the subject matter experts to be leading the investigation.
- 04:39 Now, most response plans are a combination of these approaches,
- 04:42 and I usually provide the response plan with the monitoring information so
- 04:46 the operators don't need to be referencing multiple procedures or documents.
- 04:52 A clear response plan will make it much easier for the process manager and
- 04:56 the operators to deal with the inevitable problems that will come up,
- 05:00 don't neglect this.
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