Standard Edition Section Question Answer

Q1 8th Annex A API has issued a statement

that they will no longer require
that all quality manual
changes be submitted for
review and approval prior to
implementation. API Spec Q1
states in Annex A, Section
A.3.4 Any proposed change
to the Licensees quality
program, to a degree requiring
changes to the quality manual,
shall be submitted to API for
acceptance prior to
incorporation into the
Licensees quality program.
Can it be interpreted to
exclude any changes?
Yes. The intent of the changes
referenced in the cited clause was to identify
significant changes to the quality
management system that would have a
direct impact on the product or service
provided. Minor (editorial/grammatical)
quality manual changes or those with no
direct impact on the product or service
would not require submission of the quality
manual prior to incorporation into the
Licensees quality program.
Q1 8th 4.1 In theAPI Specification Q1 -
8th Edition,Introduction
section displays Figure 1 -
Model of process-based
quality management system. It
is very definitive in indicating
that "Management
Responsibility", "Resource
Management", "Product
Realization", and
"Measurement, Analysis and
Improvement" are all
processes. Are the sub
clauses under the processes
of"Management
Responsibility", "Resource
Management", "Product
Realization", and
"Measurement, Analysis and
Improvement" considered
processes?
Yes. API Spec Q1, 8
th
Edition, Clause 0.2,
states that for an organization to function
effectively, it has to identify and manage
linked activities. An activity using resources,
and managed in order to enable the
transformation of input into outputs, can be
considered as a process. API Spec Q1, 8
th
Edition, Clause 0.1, states that the
management principles of ISO 9000 and
ISO 9004 were considerations in the
development of the document. ISO
9004:2000 states that the model shown in
Figure 1 does not show processes at a
detailed level. (Ref. ISO 9001 and ISO
9004 are consistent pair documents and
therefore applicable to the identical [boxed]
text between ISO 9001:2000 and API Spec
Q1, 8
th
Edition).
Q1 8th 4.1 In instances where the ISO
sections of API Spec Q1
require procedures, yet the
supplemental requirements of
API Spec Q1 do not
specifically require control
features or procedures, do the
ISO procedure requirements
apply to the supplemental
requirements? In other words,
must the supplemental
requirements be addressed
within procedures when the
main clause of the section (i.e.
8.3) requires a procedure,
even though the supplemental
requirements do not (i.e.
8.3.3)?
Yes. API Spec Q1, 8
th
Edition, Clause 8.3,
states that The controls and related
responsibilities and authorities for dealing
with nonconforming product shall be defined
in a document procedure. Since API Spec
Q1, 8
th
Edition, Clause 8.3.3 Customer
Notification Supplemental falls within the
Control of Nonconforming Product process
(Clause 8.3), by extension all supplemental
clauses within this process (i.e., 8.3.1, 8.3.2
and 8.3.3) are subject to the requirement for
the existence of controls in a documented
procedure.
Q1 8th 4.2.3 An SOP states that, e.g.:
Documents are updated when
the relevant changes are
required / warranted, e.g.
additional details of a
described process must be
added. Documents are
reissued upon implementation
of six changes, or when the
described by the document
process has significantly
changed. Naturally, in all the
above cases, the documents
are re-approved. Is there a
necessity to define additionally
the frequency of a document
(e.g. SOP) change?
No. API Spec Q1, 8
th
Edition, Clause
4.2.3(b) requires that A documented
procedure shall be established to define the
controls needed to review and update as
necessary and re-approve documents. The
term As Necessary in the stated clause
provides the flexibility for the user of the
document to define when review, update
and re-approval are required for the specific
situation(s) warranting this action in the
quality management system.