How to use this document
Copy the template below into your quality system. Replace every <<FILL: ...>> placeholder with your company, system, and process specifics, then route it through your own document control, review, and approval. The filled specimen shows one worked example; adapt the numbers and scope to your operation and verify each cited regulation or standard against the current source before you rely on it.
This is a generic, originally worded starting point. It contains no confidential, proprietary, or employer material, it is drafted with AI assistance and reviewed, it is not legal or compliance advice, and adopting it does not by itself create or prove compliance. See the Disclaimer and Terms.
This is a ready-to-use disclosure and screening form completed before a person-in-plant (PIP) is assigned to a campaign at a specific contract manufacturer. It separates the independence question from the training and qualification question: qualification asks whether someone can recognize a deviation, this form asks whether, having recognized one, they would actually write it down. Replace every <<FILL: ...>> placeholder and route the disqualify-or-manage decision to sponsor quality leadership, never to the function scheduling the campaign. A filled specimen follows.
Instructions
Complete this form before the first day of assignment, and again before any new assignment to a different CDMO, even for a PIP already qualified elsewhere. A fact that becomes relevant partway through a long-running relationship with a CDMO, such as a new family hire at the site, must be disclosed the moment it is known, not held until the next scheduled renewal.
Disclosure questions
Disposition
Acceptance criteria
This form meets the bar when every question above has a stated answer, not left blank; any disqualifying fact results in reassignment to a different PIP or a different CDMO, not a waiver granted under schedule pressure; and the disposition decision is made and signed by sponsor quality leadership independent of the technical operations function scheduling the campaign.
Approvals
Revision history
Filled specimen
Extract for a PIP candidate proposed for a campaign at Meridian Fill Services.
Disposition: the spousal relationship is disclosed and managed, not disqualifying, because the spouse works a different shift on a different suite with no overlap with the proposed campaign’s observation scope; sponsor quality leadership documents this rationale and adds a standing condition that the candidate discloses immediately if the spouse’s assignment changes to overlap with any future campaign at this site.
- A PIP assigned with no documented independence screening, discovered only after a finding’s credibility is questioned because of an undisclosed relationship with the CDMO.
- A disclosed conflict dispositioned informally by the same manager under pressure to keep the campaign staffed, rather than by quality leadership independent of that pressure.
- A relationship that develops partway through an ongoing PIP assignment, such as a new hire at the site, never re-disclosed because the form was only completed once at the start of the relationship.
- Set your own lookback period for prior CDMO employment based on your organization’s standard conflict-of-interest policy.
- Route every disqualifying disclosure to reassignment, never to a documented exception approved under schedule pressure.
- Require re-disclosure at the start of every new assignment to a different CDMO, not just once per individual.
