Fixed price
When the outcome can be defined in advance and you have no reason to bring the capability in-house. We commit the method, the consultants and the tools.
Engagement models · Outsourcing
Outsourcing a quality activity never transfers responsibility.
This is not an opinion: the GMP chapter on outsourced activities says so in as many words. The contract giver remains responsible, and must assess the competence of whoever the activity is entrusted to. That sentence alone ought to rule out pure staffing on a quality topic. It does not, for want of having been read.
Chapter 7
A written contract, defined responsibilities, prior assessment of the provider's competence, and final responsibility remaining with the contract giver. The text covers outsourced activities, not only outsourced manufacturing.
The practical consequence is rarely drawn: if you remain responsible for the outcome, the engagement model becomes a quality decision, not a procurement one. Buying hours without a method means taking responsibility for work whose way of being done, and whose trail, you do not control.
The belief that costs you
"It is either staffing or fixed price."
Both have their place, and both share the same blind spot. With staffing you buy hours and supply the method — if your method is precisely what is not working, you are funding the reproduction of the problem. With a fixed price you buy an outcome and lose control of how it is reached — the provider leaves, the capability leaves with them, and the need returns next cycle. On a quality programme, neither leaves the organisation stronger than it was.
Choosing knowingly
Four models, four situations.
Embedded, our method
When you have the framework and the project managers, but the way of doing it is exactly what is missing. Our consultants come in equipped — and your teams learn as they go.
Training and coaching
When the capability must stay with you. We train your teams and embed the change in their practice; they do the work, on their own files.
Embedded, your methods
When your system works and you are short of hands. Our consultants follow your procedures and your methods: we reinforce capacity, and change nothing else.
The middle model is the least known and the most useful on a system that has drifted: you keep control, you borrow the method, and it stays after we leave.
Our conviction
Our teams do not spend their time producing slide decks.
"The tough consultants who actually get things moving": that is what our clients say about us, and we take it as a compliment. A firm that leaves behind a report has produced a document; it has not changed a practice. Chapter 7 makes you responsible for the outcome — so that outcome had better be a capability installed with you, rather than a service to buy again next year.
What you gain
The capability stays, the dependency does not.
Compliance
Assessing the provider's competence, as chapter 7 requires, becomes straightforward to document when the method is explicit and its deliverables standardised.
Transfer
Your teams work alongside ours on their own files. The transfer does not happen through a training session at the end of the assignment: it happens throughout, and it can be verified.
Exit
The right end-of-assignment indicator is not satisfaction: it is whether the next file of the same kind can be handled without us. It is measured before we leave.
Frequently asked
Engagement models, plainly.
The release decision rests with the qualified person and cannot be delegated to a provider. What can be outsourced is the preparation: batch record review, investigation of deviations, getting the file into shape. The boundary must be written into the contract in black and white, as chapter 7 requires.
On real files, not on CVs. Ask for an anonymised investigation report and read it against your own criteria: does the cause explain the timing, does the action remove the cause, is the effectiveness criterion observable. Half an hour of reading will tell you more than a pitch.
As soon as a GMP-covered activity is entrusted to a third party, the principles apply: contract, defined responsibilities, assessment. The commercial form of the contract does not change the nature of the activity — and it is a point an inspector may legitimately come back to.
By defining from the outset what must stay with you: the analysis of what manufactures deviations, the arbitrations, and control of the document set. Reinforcement is about volume, not judgement. That is the line we apply, including when it shortens the assignment.
Are you buying hours, an outcome, or a capability?
All three are justified, but not in the same situations. Tell us yours and we will say which one we recommend — including when it is the cheapest.