Apologies for not writing for a while. Holidays, traveling, and such kept me from focusing on writing.
There is an appropriate push for simplification of standard operating procedures (SOPs). As well there should be. Simplification is quality. Operations love it as they should since it reduces a training burden and time to 'effectiveness'. They love it until they don't. While this post is about simplification it is also about opportunism, hypocrisy, and when it get's down to it, cooking the metrics.
I want a simplified procedure. Every effective CAPA should have an element of review of the procedure but it does not mean the expansion of the procedure. That way we do not bulk up and rely on words that frankly are not going to be read or executed each time.
I am fine with adding items to training but that is not an effective CAPA. Operations hates this as they want to move on from their mistake. Why? They hate what they consider 'wasted effort'. If they are not making product they see it as a waste of time, burden and overhead.
These are talented people with a focused mindset as we are in Quality. But their intent for product and efficiency does not take into account that compliance is part of their product.
I have preached to my people about how working on the right things is key. However, where operations tends to loose the plot is that they feel they are the final word on what is compliance. That is where the hypocrisy comes in.
They want a simple procedure, yet when something that is clearly non-compliant and in the spirit of the procedures intent, logic, or just plain regulatory requirement they hide behind "well it's not in the procedure."
I think these people are hacks. They are spineless to their superiors, but have no problem telling quality what to do because they feel ambivalent with their mission. Whatever that mission is. I am calling into question their integrity.
To my quality colleagues, you are the final word on compliance. If you are not supported by your managers, then don't work for them. Yes we are in business to make product, but not to fall over.
A couple of motivating factors for this behavior:
- Reduction of deviations or cooking the metrics
- Do not want to put time into something they feel is not value added
- Do not take ownership for their actions - 'they got caught'
- Resistance to change in the power dynamic
- They do not want limitations beyond how the procedure is written
Oh and yes, every once in a while there is a logic trap or contradiction in the procedure. During those issues, fix them. But and it's a big but (giggle), you have to read the most logical intent into the procedure. If they come at you from a literalistic sense then they can rightly F' off.
When using a procedure you need to use the frontal cortex of your brain. You cannot willfully read something that you know better about.
People that cook the numbers on metrics are falsifying data. Pure and simple.
I rather open the instance and then close it based on the rationale so it is documented. They need to own the instance. If QA F'd up, then write it down. If operations messed up then investigate it.
Simple.
This then gets us to management speaking out of both sides of their mouth. We want to reduce deviations but we don't want to stop production or invest the time.
There is then no hierarchy of control capable capable in this example system. There is willful ignorance or a straight push to not give a shit about compliance.
Your resources, training and feedback based on risk need to be practical and feedback. Otherwise you are not using risk management, you are taking all of the benefit and none of the management responsibility.
If you are using risk to NOT open deviations, you are wrong. Every issue is entered into the system and opened and then appropriately adjudicated in the QMS.
Oh yeah. To the executives that get mad at deviations that impact the bottom line. They are your fault, maybe not directly but yeah.... You own that. You have set the organization and the culture to not address things properly. Your quality culture is in question as is your leadership.
No deviation investigator should have more than 5 investigations at a time. The people investigating need to be in the department that owns the process. Metrics should be around prevention not totals of deviations (event though it shows the effectiveness). Each CAPA should be graded on a scale of the hierarchy of control. Technical writers can be used to deal with a bolus. If your system is too burdened with deviations, STOP production to catch up. Have the conversation.
Quality must own the deviation system and investigations. Investigators, as I stated previously should reside in the departments and then Quality Engineering or similar disciplines have oversight along with Quality Systems personnel.
For those who disagree the one thing I challenge is for you to explain to me the purpose of deviations and investigations and how it fits in with the regulations and guidance you are supposed to uphold.
Don't talk about wasted time, talk about your failures to develop the right culture, procedures, training and level of resources. Talk about how you value production over compliance. Then, we can have an honest conversation.