I have identified 40 procedures required by 21 CFR 820: the Quality System Regulation
- § 820.22 for quality audits…
- § 820.25(b) for identifying training needs…
- § 820.30(a)(1) to control the design of the device in order to ensure that specified design requirements are met
- § 820.30(c) to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient
- § 820.30(d) for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements
- § 820.30(e) to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development
- § 820.30(f) for verifying the device design
- § 820.30(g) for validating the device design
- § 820.30(h) to ensure that the device design is correctly translated into production specifications
- § 820.30(i) for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation
- § 820.40 to control all documents that are required by this part
- § 820.50 to ensure that all purchased or otherwise received product and services conform to specified requirements
- § 820.60 for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups
- § 820.65 for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components
- § 820.70(a) that describe any process controls necessary to ensure conformance to specifications
- § 820.70(b) for changes to a specification, method, process, or procedure
- § 820.70(c) to adequately control these environmental conditions
- § 820.70(e) to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality
- § 820.70(h) for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device’s quality
- § 820.72(a) to ensure that equipment is routinely calibrated, inspected, checked, and maintained
- § 820.75(b) for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met
- § 820.80(a) for acceptance activities
- § 820.80(b) for acceptance of incoming product
- § 820.80(c) to ensure that specified requirements for in-process product are met
- § 820.80(d) for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria
- § 820.90(a) to control product that does not conform to specified requirements
- § 820.90(b)(1) that define the responsibility for review and the authority for the disposition of nonconforming product
- § 820.90(b)(2) for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications
- § 820.100(a) for implementing corrective and preventive action
- § 820.120 to control labeling activities
- § 820.140 to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling
- § 820.150(a) for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed
- § 820.150(b) that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms
- § 820.160(a) for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution
- § 820.170(a) for ensuring proper installation so that the device will perform as intended after installation
- § 820.184 to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part
- § 820.198(a) for receiving, reviewing, and evaluating complaints by a formally designated unit
- § 820.200(a) for performing and verifying that the servicing meets the specified requirements
- § 820.250(a) for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics
- § 820.250(b) to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed
Today on Morning Edition Condoleezza Rice shared that the founders of the American republic understood institutions weren’t built for human perfections, but for human imperfections . If only present day leaders understood institutions in this way, too.
We humans don’t always act in ways that help us achieve our goals. Our imperfections get in the way. So we establish ways of doing things, patterns of behavior, to help us act appropriately. This is particularly valuable during times when our judgment is clouded.
In our pursuit of ever more ambitious goals, goals that require coordinated action of many individuals, we need a system of such procedures that is designed to help us achieve those goals. When we put these procedures into practice, we collectively move toward our goals. When this pattern of behavior persists over time, we give rise to a recognizable entity: an institution.
Institutions exist to help us act in ways that make it possible to achieve the goals we set for them. They are especially valuable at times when we experience uncertainty that stokes our primal fear.
Monday afternoons at two-thirty. That was the time for our weekly staff meeting. When I joined the company everyone was required to attend it: engineers, technicians and operators. The head of our department, the Director of Quality, led it.
It was a rare week when the meeting started on time. Mondays were also when we had our one-on-one meetings with the Director and he had one of those exchanges going on right before our staff meeting. It always went over. So several of us would gather and wait outside of the meeting room until we were noticed and motioned to come in.
Even with this routine delay I don’t remember a single week when everyone was present before the meeting started. There was frequently at least one person who creeped in late. It wasn’t always the same person either. Some late comers might put on an apologetic face at times, but a few were shamelessly indifferent of their indiscretion.
Just as the meeting never started on time, it didn’t end on time either. I recall a few occasions when I wondered whether the meeting actually ended.
The Director got our meeting going by sharing a subset of the highlights and lowlights of the previous week that he gets in an email from the corporate overlords. We cheered the highlights and bemoaned the lowlights even though none of us could draw a connection to any them with the specific work we did. They did not prompt any actions for our department. They were also divorced from similar points shared in the previous week; presented as stand-alone bits of information. On those occasions when someone did make a tentative connection, it unleashed pent up frustrations with people feeding off of each other to blame some nonpresent “they.” So what purpose did this update serve? I couldn’t tell you.
Following the update, the Director shared his schedule for the current week. It always showed back-to-back meetings, sometimes overlapping, from the start of the workday to its end, for the whole week. So when did he have time to think and plan, to draw up an agenda for his meetings, to follow-up on assignments, to analyze, understand, and guide the performance of the system he was charged to direct? At first I had felt sympathy. What sort of monstrous organization drives its people like this? But it didn’t last long. I recognized much of it was self imposed and not a demand of the organization. It was his way of showing others how busy and engaged he was, how hard he was working, how committed he was to the company. It was all light and no heat. Perhaps I’m being harsh, but I don’t think so.
After he finished his update he would ask each staff member if they had anything to share. Most did not. Some, though, shared information on what they were doing in excruciating detail. Usually it was about “unexpected” hurdles, blocks, or breakdowns. They were the same from week to week. This was another opportunity to vent about those others who didn’t follow procedures, the unreasonable surge in demand for our services, or how the system is broken and needs fixing. Who is going to fix it? How should it be fixed? What resources are needed for the fix? That requires a plan. But when is there time and space for that?
Once a month the Director would remind everyone to calculate and report metrics they were responsible for. It shouldn’t come as a surprise that at least one was delayed. Not always the same one, but it came with all the usual excuses.
That was the ritual.
Companies have been proudly proclaiming that they hire only the best and brightest. Ignoring the fact that this is a bogus claim – personal experience at a dozen different companies has demonstrated otherwise – a firm would find it all but impossible to function with the best and brightest.
Back in 1994 Dr Russell Ackoff shared an example that elegantly explains why.
I read in the New York Times recently that 457 different automobiles are available in the United States. Let’s buy one of each and bring them into a large garage.
Let’s then hire 200 of the best automotive engineers in the world and ask them to determine which car has the best engine. Suppose they come back and say Rolls Royce has the best engine. Make a note of it.
“Which one has the best transmission?”, we ask them and they go run tests and come back and say the Mercedes does.
“Which one has the best battery?” [They] come back and say the Buick does.
And one by one, for every part required for an automobile, they tell us which is the best one available.
Now we take that list and give it back to them and say “Remove those parts from those cars. Put them together into the best possible automobile,” because now we’ll have an automobile consisting of all the best parts.
What do we get? You don’t even get an automobile, for the obvious reason that the parts don’t fit!
The performance of the system depends on how the parts fit, not how they act taken separately.
A significant portion of organizational excellence depends on how employees interact with one another i.e. how they fit together, not how they act individually.
Dr. Ackoff’s entire talk titled “Beyond Continual Improvement” is worth listening to.