Standard Edition Section Question AnswerQ1 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 Licensee’s quality

program, to a degree requiring

changes to the quality manual,

shall be submitted to API for

acceptance prior to

incorporation into the

Licensee’s 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

Licensee’s quality program.

Q1 8th 4.1 In the API 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, 8th 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, 8th

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, 8th 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, 8th 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, 8th 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, 8th 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.