Quality and production pull in different directions: a fix for pharma manufacturers

A granulated blend sits in the hold area waiting for a blend uniformity result. The production head rings the QC lab four times before lunch. The analyst on the HPLC is halfway through a stability run for another product and cannot stop. By evening the compression slot is lost, the dispatch date moves, and two emails go up to the owner, each blaming the other department.

Neither side is wrong about its own job. QC is right that a result needs time and cannot be rushed into a retest. Production is right that a blend has a hold time and a customer has a date. The friction comes from the space between the jobs: nobody wrote down who decides each thing, in what sequence, and who warns whom when a plan breaks.

• Calls in place of a queue. Samples are tested in the order of whoever shouts loudest, not by dispatch date or hold time.
• Samples that arrive without context. A bag of granules reaches the lab with no request slip, batch stage or urgency marked.
• IPQA caught in the middle. In-process quality staff report to QA but sit on the floor, and production treats them as a brake.
• Line stoppages argued after the fact. An operator stops a machine for a weight variation, the shift officer restarts it, and QA hears about it at review.
• Blame in writing. Long email threads after every held batch, copied to the owner, with nothing changed afterwards.
• Quiet workarounds. Supervisors start the next stage 'at risk' without telling anyone, because asking takes longer.

Held batches and lost machine slots are the obvious losses. Less obvious is the time senior people spend refereeing. Department heads become message carriers, and sample priority lands on the owner's phone. Good analysts tire of being chased and move to plants where the lab is respected. Good shift officers tire of being blamed for releases they cannot control. Worst of all, a culture of pressure on the lab invites the shortcuts that quality systems exist to prevent.

• Different clocks. Blocks run three shifts; the lab and QA often run a general shift with thin night cover.
• Different scorecards. Production is measured on output and dispatch, QC on accuracy and turnaround. Nobody is measured on the handover between them.
• Unwritten authority. Job descriptions say 'maintain quality' or 'achieve targets'. None names who may stop, release, retest or reschedule.
• No shared plan. Planning issues the week's schedule to production; the lab learns about urgent samples only when they arrive.
• Escalation by volume. With no agreed route for a clash, the loudest voice or the most senior caller wins.

First, take the last month's held or delayed batches. For each, note where the hours went: waiting for sampling, in the lab queue, in review or awaiting a decision. Second, read the job descriptions of the production head, QC head, QA head, shift officers and IPQA staff side by side. Mark every decision that appears in two of them or in none. Third, map the lab's shift cover against the blocks' shift pattern. These three views usually explain most of the friction.

Stop a machine or line for a quality concern: any operator or IPQA officer; restart only with IPQA agreement.
Set the day's sample priority: QC head, using the planning list and hold times, at the daily call.
Start a next stage before a result: not allowed unless QA has approved it in writing for that batch.
Release or reject a batch: QA head or nominated deputy only.
Order a retest or investigation: QC and QA under the plant's own procedure, never production.
Tell planning that a release date will slip: QC head, the same day the delay is known.
Reschedule the line after a delay: production head with planning, informed by QC.
Settle a clash that the daily call cannot: plant head, within one working day, with both heads present.

The sheet is a starting draft, to be agreed between the heads and approved by the owner. Once settled, the same wording goes into each person's role description. See writing role descriptions without overlaps for the method.

Most fights are about a handful of results that stop the next step. Listing them helps the lab plan its night cover and helps production see why a slot depends on them.

• Granulation and drying. Loss on drying and blend uniformity before the blend moves to compression.
• Compression. Weight variation, hardness, thickness, friability and disintegration at the press.
• Coating. Weight gain and appearance before the lot goes to packing.
• API blocks. Reaction completion by TLC or HPLC, water by Karl Fischer and residual solvents before an intermediate moves on.
• Packing. Line clearance and the first-pack check before the run starts.

1. 1

   Agree the decision rights sheet

   Heads of production, QC and QA draft it together; the owner signs it off. Disagreements are settled once, on paper, not batch by batch.

2. 2

   Rewrite the role descriptions to match

   Every decision on the sheet appears in exactly one role. The API makers' role design page shows how this looks for block heads and QC reviewers.

3. 3

   Hold one daily priority call

   Fifteen minutes, same time each morning, with planning, production, QC and QA. The output is a ranked sample and release list for the day.

4. 4

   Use a sample handover slip

   Each sample carries the batch, stage, hold time, test needed and the time it left the floor. The lab logs when it arrived.

5. 5

   Match lab cover to the blocks

   Where the plant runs nights, put an analyst or a trained in-process tester on nights for the tests that hold a stage.

6. 6

   Give both sides a shared measure

   Release on the date promised, without a retest or an unapproved 'at risk' start. Report it weekly to both teams.

7. 7

   Review clashes monthly together

   Heads of both sides look at every escalation from the month and fix the cause, not the person.

Ask for the last month's delayed batches and where the hours went. Seat the three heads together with the draft sheet. Nobody leaves until every line has a single owner. Start the morning call the next day. The contract manufacturers' role page covers how liaison and planning roles fit in when many clients share a line. Gowning, scarce chemists and records are covered under HR support for pharma plants. A general method for sharing authority sits in our delegation of authority matrix post.