Summary
- The problem
- When a specification is revised, it is hard to tell which samples, certificates and commitments still depend on the previous version. The newest document is easily mistaken for the one that applies.
- Seal’s approach
- Tests, methods and acceptance criteria are versioned with product, stage, site, market and effective-state rules. Each test plan and certificate keeps the version it was assigned.
- What changes
- A proposed revision does not reassign work in progress or rewrite issued certificates. Its impact is reviewed for each affected sample, method and certificate before it is assigned to future testing.
- Where to start
- One specification change and the samples or certificates it could affect. Book a demo.
One specification. Every use accounted for.
A specification is used in four places: where criteria are defined, where testing is assigned, where results are reported and where change is assessed. Seal keeps tests, methods, criteria and their applicability connected across all four, so each sample, certificate and commitment can be traced to the version it was assigned. Select a stage to see the record it keeps and what it hands on.
Applicable specification version
Keep the rule separate from its presentation.
Configure test identity, procedure reference, criterion, units, calculation and reporting rules together. Preserve the development rationale and applicable compendial, customer or regulatory basis. A template displays the approved criteria; it does not define them.
Review criteria and reportable-value rules before connecting the specification to routine testing or certificate preparation.
Specification definition
- Test
- Attribute and analytical procedure
- Evaluation
- Criterion, units and calculation
- Basis
- Rationale and applicable commitments
Resolve the version for this sample and decision.
Use the product or material, stage, site, market and effective conditions to determine the applicable specification. Configure the sampling plan and test assignment, retaining the method, criteria and quantities chosen for the actual work.
Keep release and stability uses explicit. Investigate an unresolved applicability conflict rather than silently taking the newest version.
Sample test plan
- Applicability
- Product, stage, site, market and date
- Sampling
- Population, locations, quantities and rationale
- Execution
- Assigned tests, methods and criteria
Retain the criterion used when the result was evaluated.
Connect the selected result, method version, criterion and reportable-value rule to its review. Prepare the appropriate certificate or report from that context, with the template, statements and issue state kept separately from batch disposition.
Preserve the issued certificate. A correction or reassessment must retain the original evaluation and the reason for change.
Result and certificate context
- Result
- Source version and review state
- Evaluation
- Applicable criterion and reportable value
- Output
- Template, statements and issue history
Review everything that relies on the changed rule.
Assess affected methods, sample plans, open testing, stability protocols, certificates, sites, markets and commitments. Define what happens to work already in progress and which future assignments use the revision. Periodic review can bring new performance or product knowledge into this assessment.
Complete the agreed transition checks before applying the revision. Effective dates do not replace an assessment of the affected work.
Specification change plan
- Impact
- Methods, work, reports and commitments
- Transition
- Existing assignments and future effectivity
- Authorisation
- Review, approval and implementation
The newest version is not automatically the applicable one.
Specification SP-042 v06 is proposed. An in-progress sample and an issued certificate still reference the effective v05. Each of them needs its own version decision.
SP-042 / specification applicability
Proposed revision
SP042-NEXT- Candidate
- SP-042 / v06
- Approval
- Pending
- Effective date
- Not assigned
SP-042 v06 is a proposed revision. Product, stage, site, market, method references and implementation conditions still need review before applicability is established.
What follows
Complete the change and applicability review before assigning v06 to future testing.
v06 is not effective. The in-progress sample and issued certificate retain v05. I would review each affected consumer before deciding which future work can use the proposed criteria.
SP-042 / v06 implementation review
DraftNo automatic reassignment. Preserve the current sample and certificate context while reviewing the proposed revision.
QC owner
Assess the impact on S-042-18 without silently changing its assigned criteria.
Certificate owner
Preserve the issued v05 certificate and use an amendment process if required.
Specification owner
Resolve approval, applicability and implementation conditions for v06.
Keep each criterion with its method and scope.
Why teams choose Seal for specification management
Specifications are traditionally controlled documents whose limits are copied into LIMS test plans and certificate templates, so a revision has to be carried into each copy by hand. Seal holds the specification as versioned configuration with its applicability rules, and each test plan and certificate references the version it was assigned.
A revision is assessed against the samples, methods and certificates it would affect before it is assigned to future testing, and work in progress keeps its version.
A limit has a method and a purpose.
Keep the analytical procedure, reporting rule and intended decision with the acceptance criterion.
Record units, numerical or qualitative evaluation, rounding and method version. Review differences between release and shelf-life criteria rather than allowing a display template to determine which rule applies.
Effective does not mean universal.
A specification can have different applicability across products, sites, stages or markets.
Retain the basis for each difference and the relevant implementation conditions. A new publication, customer request or method revision should trigger an impact assessment, not a blanket replacement of all current criteria.
Connected to the surrounding work.
Keep specialised systems where they belong. Agree the source of each record, the permitted actions and the reconciliation at each handoff.
Explore integrationsAQuestions and answers
Can release and stability specifications differ?
Yes, where appropriate and justified. Keep the intended use and applicable criteria explicit so that a result is evaluated against the correct basis.
Does a new version change old results?
No. Preserve the criterion and method used at the original evaluation. Reassessment or correction must be a separate attributable action with its rationale.
Can specifications remain in another system?
Agree the authoritative source, identifiers, versions and applicability rules. Scope the connection and test how revisions, missing references and effective dates are handled.