I wrote earlier about the front-loaded nature of Quality. On the back end of that process is reviewing and approving documents prior to their use for regulated activities. When assessing the quality culture of an organization, one thing I note is the number of review/approve signatures on a document. Immature organizations have MORE signatures than mature organizations. Yes, mature Quality organizations have fewer signatures! Let me help you understand why.
Required Signatures
Start with the regulations.
21 CFR 211.100: These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
21cfr 820.40: (a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented.
EU Chapter 4: Documentation
4.3 Documents containing instructions should be approved, signed and dated by appropriate and authorized persons.
So we need someone to check the document for technical accuracy and completeness, and someone from the Quality unit to approve it. We should add someone who is responsible for the document and the business activity it directs, to comply with the EU statement of an “authorized person”. That gets us to required signatures—three, maybe four signatures at the most.
Now, what roles do we see on a document? Let me draw on experience: Author, Author’s Team Lead, Production Lead, IT Validation Leader, Project Leader, Engineering Lead, Safety Director, Quality Leader, Site Management Leader, etc. I am sure I missed some, but the point here: there is an arm’s length of people required to sign before the document becomes effective. Have you seen a list like this? Yes, me too.
The Fallacy of Review
When there is a long list of reviewers, the review quality goes DOWN. Why? Simple human nature. Everyone on the list believes everyone else will properly review it, so each signatory will give it a cursory glance, sign and pass along to the next person. Remember that old story about Everybody, Somebody, Anybody, and Nobody?
Everybody, Somebody, Anybody, and Nobody were members of a group. There was an important job to do and Everybody was asked to do it. Everybody was sure that Somebody would do it. Anybody would have done it, but Nobody did it. Somebody got angry because it was Everybody’s job. Everybody thought Anybody would do it, but Nobody realized that Anybody wouldn’t do it. It ended up that Everybody, blamed Somebody, when Nobody did, what Anybody could have done.
A variant is the short version: That which belongs to Everybody belongs to Nobody.
It might seem counter-intuitive, but review quality goes UP with fewer reviewers because there is CLEAR ACCOUNTABILITY. When there were three other technical reviewers, I had cover if something important was missed, so I could perform a mediocre review; but when I become the sole technical reviewer, there is no place to hide—the oversight is on me. So I better make sure it is right before signing. I might even ask someone to read a section for me, to make certain that I didn’t overlook something important. I look carefully because there is accountability for my failure. And this is exactly the behavior we want: everybody personally owns quality.
There is one related issue that can cause large signature lists: communication. I have seen situations (e.g. change control, release management, testing) where document review/approve lists are used as the means of notifying people in the organization about a proposed change. In other words, a long signature list becomes the communication mechanism for the business team, the substitute for communication. Ask yourself: is it more efficient to (1) bury a message in a lengthy document that might be reviewed by people over two weeks, or (2) send a short email or test message to the same list of people at one time?
Yes, I knew which answer you would choose.
Other “Benefits” of Long Review/Approve Lists
There are two additional “gifts” that come from long lists for review/approve: (1) longer time periods must be planned to get documents reviewed/approved at various stages of a project—resulting in longer project times with greater costs; (2) every error in a document requires the long list to be completed-again. This encourages people to NOT make changes, because the re-approval takes too long. The wrong behavior is reinforced.
Summary
If you have long review/approve lists for your documents, please stop. Do your organization a favor and challenge the need for every signature—ask: could we replace that signature with a communication message? You will increase the right behaviors, and keep projects moving forward in a timely and cost-effective manner. See, once again Quality is trying to save you money, if you listen.
Originally published by Mark Newton (Principal) on 18 July 2018