The standard-practice exclusion of design and development at a build-to-print fabricator
Tessera Metalworks is a 38-person sheet-metal fabricator supplying enclosures to telecom and rail customers. Its quality manual states: "ISO 9001 clause 8.3 Design and development is not applicable - we manufacture strictly to customer-supplied drawings." In practice four things happen. (a) For two rail customers, Tessera engineers proposed changing from 2 mm to 1.5 mm stainless steel and revising a bend radius, and wrote the technical justification the customer signed off. (b) Tessera designs its own weld fixtures and press tooling, which are used only in its own production. (c) Sales occasionally issues an internal "concession drawing" to the shop floor when a customer drawing carries an ambiguous tolerance, resolving the intent without customer sign-off. (d) Powder coating and laser cutting are outsourced to two suppliers, one of which is not on the approved supplier list. The certification body is at stage 2. The QMS manager argues the exclusion is industry standard and that adding 8.3 would create bureaucracy with no benefit.
1. Is the exclusion of 8.3 justified? Analyse items (a) to (d) separately - some support the exclusion, some destroy it, and one is unrelated to 8.3.
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Item (a) destroys the exclusion. Proposing a material thickness change and a bend radius revision, and authoring the justification, is design and development output (8.3.3, 8.3.5) and a design change (8.3.6). That the customer approves the change makes the customer a reviewer of Tessera's design work, not the designer. Fit, form, function and regulatory characteristics of a rail enclosure are affected by wall thickness - this is not a manufacturing detail.
Item (b) does not trigger the exclusion question. Tooling and fixture design for the organization's own production is manufacturing engineering, addressed under 8.5.1 (controlled conditions) and 7.1.3 infrastructure. It is not the design of the product or service delivered to the customer. Confusing the two is the most common error in this argument.
Item (c) is a requirement-determination failure, not an 8.3 question. Resolving an ambiguous customer drawing without customer sign-off means Tessera is defining requirements itself, which engages 8.2.2 (determining requirements for products and services) and 8.2.3 (review before commitment). If the resolved tolerance changes what the customer asked for, it can also be a design change under 8.3.6.
Item (d) is unrelated to 8.3. It is an 8.4 external provider control failure - a process affecting conformity is performed by a supplier not evaluated or selected under 8.4.1.
Correct application: 8.3 applies to item (a). The exclusion statement is invalid as written, and the QMS manager's "industry standard" argument is an appeal to custom, not to 4.3.
2. What does the standard require the organization to document about its scope, and what are the consequences of a requirement being declared non-applicable?
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Clause 4.3 requirements. The organization must determine the boundaries and applicability of the QMS, considering 4.1 (external and internal issues) and 4.2 (requirements of interested parties) and the products and services it provides. It must then:
- keep the scope available as documented information;
- state the types of products and services covered;
- provide justification for any instance where a requirement of the standard cannot be applied.
The test for non-applicability is not "we do not have a design department". It is whether the requirement can be applied and, if it is judged not applicable, whether that determination affects the organization's ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction. Requirements are only excluded if they fall outside the scope of the QMS once that scope is properly determined - the exclusion cannot be used to make a real activity disappear.
Consequences for Tessera:
- The scope statement and justification are inaccurate documented information (7.5.3), which is itself a nonconformity.
- Rail enclosure design activity proceeds without design inputs, reviews, verification or change control (8.3.2–8.3.6), so a defect traceable to the 1.5 mm thickness has no controlled path back to a decision record.
- At stage 2, an auditor who finds (a) will test whether the exclusion was a deliberate determination or a convenient one - and will then sample the design records that should exist and do not.
- Recovering the position requires re-scoping, defining a design process proportionate to the work (two rail customers, a handful of changes per year is enough to justify a light process), and transferring existing justification documents into it as design records.
3. Item (c) - the concession drawing - is arguably the most dangerous practice described. Argue why, and state what you would require instead.
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Why it is the highest-risk item: it is invisible to the customer, undocumented as a deviation, and it changes what is built.
A customer drawing with an ambiguous tolerance means the requirement is not determined (8.2.2) and not reviewed before the organization commits to supply (8.2.3). When sales resolves the ambiguity internally and issues a drawing to the shop floor, three things happen at once:
- Requirements are defined by the wrong party without authority. The customer's specification is being interpreted by a supplier function that may not have the technical basis, and the interpretation becomes the de facto requirement.
- Conformity becomes unverifiable. At 8.6 (release of products and services), the inspector measures against Tessera's internal drawing, not the customer's. A part can be "conforming" and rejected by the customer - or accepted by the customer and non-conforming to the actual drawing.
- Traceability is broken. If a fault later surfaces, the as-built configuration exists only on an internal sheet with no revision control linking it to the customer's drawing revision.
What to require instead:
- A documented clarification request to the customer, with the customer's written answer retained as design/requirement input.
- Where a deviation is genuinely needed, a controlled concession or deviation record with customer approval, a defined quantity or time limit, and a link to the affected serials.
- A rule that no drawing reaches the shop floor without an identifiable source revision; internal interpretation notes are permitted only as records attached to an answered clarification, never as a substitute for one.
This is not bureaucracy. It is the difference between an ambiguous requirement that is resolved once, with evidence, and one that is silently reinvented per order.