WIPWork in Progress

Work In Process — WIP — is the inventory caught in the middle of being made. It is no longer a raw material because it has been transformed, weighed, blended, granulated, encapsulated, partially filled or partially assembled. It is not yet finished goods because it still needs more processing, QC release, packaging or labelling before a customer can buy it. In accounting WIP is a balance-sheet category; on the shop floor it is the most volatile, hardest-to-control class of inventory in the building.

In a regulated environment WIP carries the same paperwork as any other regulated material. Every WIP container has a lot number (often a sub-lot of the parent batch), an expiry or hold-by date, a quarantine or release status, a storage condition, and a location. Movements that affect identity, status, quantity or traceability are recorded so the history of the container can be reconstructed. Where appropriate, 21 CFR 211.111 expects time limits on in-process steps, because long or unvalidated holds invite microbial growth, segregation, degradation or contamination.

WIP is also the inventory category that the ERP almost always gets wrong. A monthly ERP cycle count of WIP is meaningless because by the time the count is done, the WIP has moved. Real WIP control is a shop-floor problem, owned by the MES and the WMS together, with the ERP picking up the periodic financial snapshot at month-end.

WIP is not one thing. It is at least seven distinct sub-types, each with its own handling rules.

Each form behaves differently. Dispensed kits are time-limited per the SOP or BMR — sometimes within a shift, sometimes longer, depending on risk and validation. Bulk in stainless tanks runs on its validated hold time. Sub-assemblies in cleanrooms have environmental constraints. Held material remains subject to expiry, retest and validated stability limits; if those limits may be breached the hold itself becomes a deviation. WIP control is the discipline of knowing which form each container is in and what rule applies.

Generic factories track WIP for working-capital reasons — money tied up in unfinished goods. Regulated factories track WIP because every WIP form has a regulatory clock attached to it. The clock comes from three sources.

Microbial and chemical stability

A wet granulation left in a tote for 96 hours may grow yeast. A protein intermediate in a bag at room temperature may aggregate. A susceptible API in solution may degrade. The validated maximum hold time is established during process characterisation and locked into the BMR. The WIP system must enforce it or escalate before it is breached.

Mix-up risk

WIP that sits around for days starts to look like other WIP. Labels fade. Operators forget which tote came from which batch. The longer WIP sits in motion, the higher the mix-up risk. Line-clearance and segregation procedures are the static defence; the dynamic defence is keeping WIP moving and timestamped.

Audit visibility

An auditor who sees ageing WIP on the floor — drums with no labels, totes with missing batch tags, half-built kits in a corner — will read the operation as out of control regardless of what the records say. WIP age is a leading indicator of operational discipline.

Line clearance is the procedure that confirms a line is empty of the previous product before the next product runs. WIP is what line clearance is hunting for. A failed line clearance is almost always a WIP-management failure — a tote left in a corner, a kit not returned, a sample bottle on a shelf, a partially filled drum behind a pillar.

A WIP system that knows where every container is reduces line-clearance from a 45-minute search to a 5-minute confirmation, because the system can tell the line-clearance officer 'asset WIP-2381 is the only container from the previous batch still on this line, and it is at location BIN-12'. See line clearance for the full procedure.

Every batch ends with a yield reconciliation: theoretical yield minus actual yield equals variance, and the variance must be explained. WIP is where variances hide. A 2% loss might be entirely real (process loss to dust collectors and equipment hold-up) or it might be a tote of bulk parked in the wrong room two weeks ago.

Strong WIP control closes the reconciliation loop: every WIP container has a parent batch, every transfer is logged, every disposition (released, scrapped, sampled, returned to stock) is timestamped. When the BMR is reconciled, the WIP system can hand the QA reviewer a complete movement history rather than a polite shrug. See in-process reconciliation and yield reconciliation for the deeper mechanics.

Every WIP container has a status that drives where it can sit and what can be done with it. The four cardinal statuses are quarantine, released, rejected and on-hold. The system must prevent movements that would mix statuses — a released tote cannot be put into a quarantine zone, a rejected drum cannot be picked into a production order, an on-hold container cannot be sampled without a hold-release signature.

Physical segregation (zones, cages, painted floor markings) is the backstop, but in a high-mix plant physical segregation alone is not enough. Status enforcement at the system level — where a scan refuses to accept a put-away in the wrong zone — is what catches the human errors that physical segregation misses.

The minimum data model for a regulated WIP record is unforgiving. Anything less and you cannot reconstruct what happened.

• Container ID (licence plate / SSCC) — globally unique, never reused.
• Parent batch and sub-lot — the genealogy thread back to the source.
• Material code and description — what is in the container.
• Quantity and unit of measure — with separate net and gross where relevant.
• Status (quarantine, released, rejected, on-hold) — with the timestamp of the last status change.
• Location (zone, rack, bin, line position) — with the timestamp of the last move.
• Manufactured-at / packed-at timestamp — for the hold-time clock.
• Expiry, retest or use-by date — for FEFO and ageing reports.
• Operator and equipment IDs — who and what created it.
• Audit trail of every change — ALCOA+: Attributable, Legible, Contemporaneous, Original and Accurate, plus Complete, Consistent, Enduring and Available.

Across audits and Form 483s, the same WIP failure modes recur.

1. Unlabelled or mis-labelled containers — a tote with a faded label, a drum with a paper sign taped on.
2. Aged WIP with no disposition — kits returned to stock but never re-released, samples taken but never logged back.
3. Status drift — a container marked released in the system but physically sitting in quarantine, or vice versa.
4. Missing hold-time enforcement — a granulation left for 48 hours when the validated hold is 12.
5. Lost containers — system says one location, physical inventory says another.
6. Mixed status in the same zone — a rejected drum next to released material because the cage was full.
7. Phantom WIP — the system thinks a container exists but it has actually been consumed or destroyed.
8. Negative WIP — a system glitch that lets you pick more than the container holds, creating an impossible balance.

Operations and quality should be watching the same WIP metrics, even if they care about different aspects of them.

V5 Ultimate handles WIP at the container level inside the same data model that runs the batch record, the WMS, the QC release and the reconciliation. There is no separate WIP system to integrate.

• Every WIP container has a unique licence plate, a parent batch, a sub-lot and a full genealogy thread.
• Status (quarantine, released, rejected, on-hold) is enforced at every scan — wrong-zone put-aways are refused with an explanation.
• Hold-time clocks are driven by the BMR and escalate before they breach, so the operator knows what to do before the deviation lands.
• FEFO and FIFO picking rules use the WIP age automatically; the operator cannot override without a witnessed e-signature.
• Cycle counts can be run by zone, by status, by material or by batch, and reconcile back to both the BMR and the ERP.
• Aged-WIP and hold-breach reports are first-class dashboards, not buried in an export.
• Every move generates an ALCOA+ audit-trail entry — Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring and Available — by construction.
• Reconciliation at batch close knows the full container history, including every sample pull, every return and every disposition.