Knowledge sits with a few seniors: a fix for pharma manufacturers

In an API block, one senior chemist decides when a crystallisation is ready to filter. He looks at the slurry, checks the temperature trend and waits a little longer than the batch record says when the seed has been slow. The SOP gives a time range. He gives the judgement. When he takes a month off for a wedding in his village, the next two batches filter early, the yield drops and the mother liquor carries more product than it should.

Every pharma plant has people like him. A compression setter who knows which punch set caps on the hygroscopic product and how to tune pre-compression to stop it. An analyst who can bring a drifting HPLC baseline back before a release run. A coating operator who reads the tablet bed and adjusts spray rate by eye. A vaidya in a herbal unit who knows how long each root should soak. Their skill is a strength until the day they are not there.

• Batches wait for one person. A step is held until a particular chemist or setter arrives, whatever the roster says.
• Night shifts call the same phone. A senior gets calls at home because nobody on shift can read a problem.
• Leave is refused or rationed. The person cannot take a proper break without the plant feeling it.
• Juniors stop learning. They are told to wait for the senior, so they never try the judgement call themselves.
• Problems repeat when the senior is away. Capping, sticking, slow filtration or a failing system suitability check appear only on certain days.

Lost batches, lower yields and delayed releases follow on the days the senior is absent. Bigger is the exposure. A resignation to a rival takes the know-how to a competitor. An illness or retirement can stall a product until someone relearns it by trial. During an audit, a process that only one person can explain looks fragile. And the senior carries a weight that wears them down, which itself raises the chance they leave.

• The SOP records the steps, not the signs. It says filter after cooling; it does not say what a ready slurry looks like.
• Seniors are rewarded for being needed. Status on the floor comes from being the one who can fix it.
• Nobody is given time to teach. The senior runs the batch; teaching a junior slows it down.
• Backups are not named. Everyone assumes someone could step in, but no one has been trained to.
• Hiring waits for the vacancy. The second chemist or analyst is recruited only after the first one resigns.

Gather the heads of production, QC and engineering for one afternoon. For each product, critical step and key instrument, ask one question: if this person did not come in tomorrow, could the work go on at the same quality? Write down every 'no'. The sheet below gives the columns.

Product, step or instrument: for example, crystallisation of an intermediate, compression of a hygroscopic tablet, HPLC system for related substances.
What the senior judges that the SOP does not say: the signs, timings or adjustments they rely on.
Who holds it today: one name.
Who could stand in now: a name, or none.
Risk if the holder is absent: batch held, quality risk, yield loss or release delay.
Backup named for training: name and start month.
Watch-points sheet written: yes or no, and date reviewed.
Backup signed off to work alone: date and by whom.

1. 1

   Name one backup for each 'no' on the register

   Choose someone with the base skill and the interest, and tell both people why. Make it part of the backup's appraisal goals for the year.

2. 2

   Write a one-page watch-points sheet

   The senior describes the signs they look for, the adjustments they make and the mistakes they have seen. HR or a trainer writes it up in plain words; QA reviews whether any of it should enter the controlled procedure.

3. 3

   Practise under supervision

   The backup runs the step or instrument with the senior watching, on real batches, until they can make the call themselves. A shadow log records each attempt.

4. 4

   Use teach-back to check understanding

   The backup explains to the senior, in plain terms, what they would do if the slurry, the tablet or the baseline behaved oddly. Gaps show quickly.

5. 5

   Sign the backup off formally

   Once ready, record the sign-off in the training file and the skill matrix, and roster the backup on the step regularly so the skill stays fresh.

6. 6

   Recognise the senior for teaching

   Make knowledge transfer part of what a senior is valued for, in appraisal and in pay, so sharing never feels like handing over status.

7. 7

   Hire the second chemist or analyst early

   For the scarcest roles, recruit before the gap opens, so the overlap with the senior is months rather than days. Succession planning sets the order in which to do this.

Recruiting a second chemist or analyst for a critical role? Test the base skill and the willingness to learn from a senior. Ask a candidate to describe a time they learnt a tricky method from someone else, and what they wrote down. Make the overlap period part of the offer, so the person knows they will shadow before they own the step. The herbal makers' succession page shows how this works where formulas live with one elder.

Fill the register this month and pick the three riskiest lines. Name backups for those and start the watch-points sheets before anything else. Use the tablet makers' competency page for how setters and tooling technicians are mapped. Our post on the one-resignation test gives the owner a useful prompt. For gowning, handover and recruitment in the same industry, see pharmaceutical plant HR.