01QC Is Not Proofreading ── Where This Installment Sits
Say "QC" on a production floor and most people picture a red pen catching typos. That is one slice of it. In this series, QC means the whole process of inspecting a near-final material against a defined checklist, mechanically, and logging a pass/fail with findings. It is not a veteran's intuition; it is a net that catches the same things no matter who runs it.
Of the ten phases and four gates from installment two (Lifecycle Design), QC sits at Gate C. After material clears Gate A (concept and primary sources) and Gate B (the regulatory map), QC is the checkpoint that confirms it was built to spec. Only then does Gate D (QA) issue the final quality-assurance verdict.
The aim here is to stop QC from depending on one person's skill. For each of five lanes — consistency, typos, citations, figures, visuals — we fix what to inspect, in what order, against what source, and where to record it.
02Split QC and QA First
Before writing the SOP, draw the line between QC and QA in plain words. Build procedures on a fuzzy boundary and you get double-coverage on some items and zero coverage on others.
| Lens | QC (Gate C) | QA (Gate D) |
|---|---|---|
| Question | Built as instructed? | Is the instruction sound; may it ship? |
| Object | The material (layout, copy, figures, data) | Material + process records + regulatory call |
| Verdict | Pass/fail per item (objective) | Overall release decision (judgment) |
| Owner | A different person in the team (not the author) | A QA owner independent of production |
| Record | QC sheet (item × verdict × finding) | QA ruling (approve / return / conditional) |
| Typical miss | Typo, figure-number drift, missing source | Exaggerated claim, off-label implication |
The final regulatory call belongs to QA, but QC still inspects whether the constraints fixed in the regulatory map (04 MSA Guidelines, 03 Ad Standards) are actually reflected. If Gate B fixed "indications limited to approved wording," QC checks the text against the approved range. Whether an implication beyond that range crosses Article 66 of the Act (exaggerated advertising) is QA's call to make.
03The Whole SOP ── Five Lanes and Their Order
Divide QC into five lanes. The order matters: a downstream lane is wasted if its foundation has shifted, so build from the base up.
- Consistency lane ── material matches the brief and design (clear this first; if it fails, the rest is moot)
- Typo/notation lane ── characters, terminology, units, numbers
- Citation lane ── trace to primary sources, completeness of references
- Figure lane ── figure numbers, captions, transcription accuracy of data
- Visual lane ── color, font, placement, PI/package-insert formatting requirements
Each lane runs in two stages: self-QC (the author) and peer-QC (a different person). The author self-checks against a sheet before handoff; peer-QC then re-inspects the same lanes independently. Routing only self-checked work to peer-QC lightens the peer load and pushes fundamental misses upstream where they are cheaper to fix.
04Consistency Lane ── Reconcile Against the Brief
Consistency QC reconciles the material against the brief, the design, and the locked copy. It does not hunt for new errors; it hunts for deviations from what was already fixed.
| Check item | Source of truth | Pass criterion |
|---|---|---|
| Product / generic name | Approval info, brief | Exact match to approved name (incl. ® position) |
| Indication wording | Package insert, locked copy | Word-for-word match to locked version |
| Dosage | Package insert | Numbers, units, route match the insert |
| Headlines / catch copy | Approved copy list | No substitution or alteration |
| Cautions / contraindications | Regulatory map (Gate B) | All required items present |
| Version / revision date | Version ledger | Matches latest approved version, no stale carryover |
During layout the designer pulled old copy, leaving the indication one version behind. The body text is current, so nothing looks wrong at a glance.
Locked copy is version-numbered; consistency QC records one item: "indication wording in body = copy ledger v3.2, exact match," reconciled and logged.
Always record the version you reconciled against. When tracing back later (installment ten, in preparation), if you never logged which version was compared, you cannot pinpoint when the error entered.
05Typo/Notation Lane ── An SOP for Terminology
Typo QC fails when it relies on re-reading. The SOP splits the unit of inspection and runs multiple passes. Try to see everything at once and the brain fills in meaning, skating over character-level errors.
- Pass 1 (reverse read) ── read sentence by sentence from the end, cutting comprehension to see only the glyphs
- Pass 2 (term list) ── reconcile against the house style sheet and product glossary (notation drift, okurigana, loanwords)
- Pass 3 (numbers/units) ── two-person read-aloud of numbers, units, digits, %, significant figures against the primary source
- Pass 4 (proper nouns) ── product, person, institution, trial names against approval info
| Item | Typical error | Method |
|---|---|---|
| Notation drift | "mg/day" and "mg/d" mixed | Unify via term list, verify global replace |
| Spelling variants | "-ize" and "-ise" mixed | Follow style sheet, search-verify all instances |
| Number transcription | "45.6%" typed as "46.5%" | Two-person read-aloud (reader + checker) |
| Units | μg vs mg mix-up | Read units aloud against the source |
| ™/® | Missing or misplaced trademark mark | Reconcile against first-use rule |
06Citation Lane ── Back to the Primary Source
The heart of citation QC is whether a statement can be traced back to a primary source. Statements sourced from secondary material (slides, summaries, competitor decks) are themselves a breeding ground for error.
| Check item | Pass criterion |
|---|---|
| Source exists | Every claim is tied to a source listed in the reference block |
| Primary-source nature | Traced to the original paper, insert, or review report (secondary citations flagged for re-check) |
| Citation accuracy | Numbers, population, endpoint match the original; no context-stripping |
| Reference completeness | Author, journal, volume, page, year present (house format) |
| Data nature / COI | Subgroup or exploratory endpoint stated as such |
| Consistency with approval | Citation does not imply off-label use (escalate to QA if it does) |
"Significant difference on the primary endpoint." Trace to the original and that endpoint is secondary; the primary endpoint showed no significant difference. The mix-up came from a second-hand citation off a slide.
Citation QC opens the original PDF and reconciles the table's endpoint category, p-value, and population one-to-one with the material. The reference block records DOI and exact page.
If a citation leads to an off-label implication, or risks crossing the activity constraints of the MSA guidelines (04 MSA Guidelines, 05 MSA Q&A), QC holds the verdict and escalates to QA. The final regulatory call is QA's; QC does not unilaterally stamp "no issue."
07Figure/Visual Lane ── Transcription and Format
Figures take in the most errors and surface the fewest. No matter how many times you read the body, your eye rarely reaches an axis label or a table cell. Stand figure QC up as its own inspection.
| Category | Check item | Pass criterion |
|---|---|---|
| Figure number | Number matches body reference | "See Fig. 3" — Fig. 3 exists and matches in content |
| Caption | Title, footnote, source | Source, n, units, statistical method shown in-figure |
| Data transcription | Numbers in graph/table | Two-person read-aloud of every value vs. source |
| Axes / legend | Axis labels, scale, legend | Units, range, group colors accurate; no misleading edits |
| Visual emphasis | Color, bold, arrows | No leading emphasis on only the favorable portion |
| Format requirements | Font, margins, PI/insert | Meets minimum type size and mandatory-display rules |
The visual lane also carries the format requirements demanded by the ad standards (03 Ad Standards) — type size and placement of cautions, for instance. Not design beauty, but mechanical confirmation that prescribed requirements are met.
08Record Forms and Escalation ── Operationalizing the SOP
An SOP only works paired with record forms. Inspect without recording and you lose the basis for the verdict, the means to prevent recurrence, and traceability. Here is the minimum QC sheet.
| Field | Entry |
|---|---|
| Material ID / version | Identifier and version of the material |
| Lane | One of consistency / typo / citation / figure / visual |
| Item | Each row of the checklist |
| Source | Version of the primary source / brief reconciled against |
| Verdict | Pass / fail / hold (QA escalation) |
| Finding | Location and concrete content |
| Owner / timestamp | Self-QC / peer-QC performer and time |
| Fix / re-check | Result of re-QC after correction |
On a "fail," run the fix → re-QC loop and log the re-check result on the same sheet. On a "hold," escalate to QA. Writing the escalation criteria into the SOP keeps QC from hoarding regulatory judgment and puts the call in the right hands.
- Suspected implication beyond the approved range → QA (assess Articles 66 / 68)
- Mention of unapproved drug or off-label use → QA (assess Article 68)
- Suspected breach of MSA activity constraints → QA (04 MSA Guidelines call)
- Inconsistency with the JPMA code or creation guide → QA (06 JPMA Code / 07 JPMA Creation Guide)
Exaggerated advertising is Article 66, pre-approval advertising is Article 68, and the duty-of-effort on information provision is Article 68-2 — sharing this mapping with QC keeps the issue sharp at escalation. The record form also feeds traceability (installment ten, in preparation). With QC sheets in hand, you can later reconstruct when, in which version, by whom, and what was missed.
- QC is the objective inspection of "built as instructed"; QA is the overall judgment of "may it ship." One person must not do both in one pass.
- Clear the five lanes — consistency, typo, citation, figure, visual — in order; QC is not done until all five carry a verdict. Numbers and units always get a two-person read-aloud.
- An SOP is a set of three: checklist, inspection steps, record form. QC does not hoard regulatory calls; it escalates to QA by the stated criteria.
- MHLW, Guidelines on the Sales Information Provision Activities for Prescription Drugs, 2018 (in force 2019). (Basis for QC escalation criteria.)
- MHLW, PSEHB, Commentary and Points of Note on the Standards for Fair Advertising of Drugs, 2017. (Inspection basis for format and misleading-prevention.)
- JPMA, Guide for Preparing Product Information Summaries for Prescription Drugs, latest ed. (Basis for figure and reference formatting.)
- JPMA, Code of Practice, latest ed. (Self-imposed standard for citation and information provision.)
- Pharmaceutical Affairs Law Study Group, Article-by-Article Commentary on the PMD Act, Jiho. (Articles 66 / 68 / 68-2.)
- Yoshinori Iizuka, Fundamentals of Quality Management, Japanese Standards Association. (QC/QA role split and inspection design.)
- ISO 9001:2015, Quality Management Systems — Requirements. (Framework for records and corrective action.)