In this issue
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Measuring & Monitoring Equipment Calibration Results vs. the Requirements of Q1, 8.3.3
Q1, clause 8.3.3 states:
"Customer notification — Supplemental
The organization shall notify customers in the event that product which does not conform to design acceptance criteria (see 3.1.6) has been delivered. The organization shall maintain records of such notifications (see 4.2.4)."
Depending upon the impact of a nonconformity and the results of your evaluation, a product recall may be necessary. However, prior to jumping to conclusions, a logical analysis of evidence should be performed to ensure that your organization does not unduly compromise its reputation. In this edition we will provide you an example and some logical steps for resolution.
Calibration
Range |
As-Found |
As-Left |
| 0 |
1 |
0 |
| 25 |
27 |
25 |
| 50 |
54 |
50 |
| 75 |
81 |
76 |
| 100 |
108 |
102 |
This example is for illustrative purposes. It does not contain any specific unit of measurement and can be adapted to any product specification or type of measuring & monitoring equipment.
- Acceptance criteria is + / - 2
- As-Found readings indicate that 3 readings exceed the established acceptance criteria
- As-Left readings indicate that the measuring and monitoring equipment was adjusted to comply with the acceptance criteria
- The As-Found results could mean that the product is in a state of over the tolerance published by a product specification. If the results were minus (-) in lieu of plus (+) the results could mean that the product is in a state of under tolerance.
| Which Q1 elements interface with this example? |
| Requirement |
Criteria |
Criteria potentially compromised? |
| Control of monitoring and measuring devices |
7.6 |
Design Acceptance Criteria |
| Control of records |
4.2.4 |
| Design and development outputs |
7.3.3 |
| Control of monitoring and measuring devices |
7.6 |
Manufacturing Acceptance Criteria |
| Control of records |
4.2.4 |
| Planning of product realization |
7.1 |
| Control of production and service provision |
7.5.1 |
What evidence would need to be provided
to meet the new criteria of Q1, 8.3.3? |
| 1 |
Document the nonconformity to the requirements of Q1, 8.3. |
1 & 2 |
| 2 |
Analyze all inspections / tests performed from the last calibration to the current calibration which yielded the results shown in this example. |
1 & 2 |
| 3 |
Determine the extent of the nonconformity and it impact upon (1) the product, (2) the design acceptance criteria [3.1.6] and (3) manufacturing acceptance criteria [3.1.10] by reviewing the steps identified in Q1, 8.3.1(a) and (b). |
1 & 2 |
| 4 |
Document the results of the analysis and your determination. |
1 & 2 |
| 5 |
If design acceptance criteria have not been compromised, Q1, 8.3.3 does not require the customer to be notified. Go to step #9 below. |
2 |
| 6 |
If design acceptance criteria have been compromised, evaluate the Q1, 8.3.1 (b) to determine if the design acceptance criteria can be changed. |
1 |
| 7 |
If the nonconformity still exists, identify the customers who may have been impacted by the nonconformity. |
1 |
| 8 |
Notify customers of the existing condition. |
1 |
Note: Q1, 8.3.3 does not identify how to notify the customer; notification could be outright or it could be in the form of a request to allow for the departure from specified requirements.
Any request should be accompanied by the notification of nonconformity.
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| Prudence dictates that an engineering evaluation also accompanies the notification to provide a foundation for the customer to base their decision and to minimize the evaluation time they have to put into the review. |
| Personal communications with the customer along with a solution could help minimize the impact (e.g., visit, by phone; make it personal). |
| But Remember - if a deviation from the Product Specification is accepted by the customer, you are not permitted to apply the API Monogram (refer to Q1, Annex 1). |
| 9 |
If your analysis did not yield any noncompliance with design acceptance criteria, select the appropriate action in accordance with Q1, 8.3.1 (a) |
2 |
| 10 |
Maintain detailed records of all actions taken to ensure that product complies with the API Product Specification, API Spec. Q1 requirements, your Quality Management System and Design and Product Requirements. |
1 & 2 |
| Key |
| 1 |
Design Acceptance Criteria |
| 2 |
Manufacturing Acceptance Criteria |
Update on SC-18, TG-1, Auditing Effectiveness
The SC-18 meeting was held at the API’s Winter Standardization Conference in Calgary Canada where I made a presentation regarding the status of TG-1.
Prior to the meeting, I met with the product subcommittee chairs with the assistance of the API Standards Associates and made successful presentations to the following groups to provide an update about TG-1’s activities and to seek volunteers:
- Task Group on Line Pipe (SC 5 / TGLP)
- Task Group on Oil Country Tubular Goods (SC5 / TGOCTG)
- Subcommittee on Valves and Wellhead Equipment (SC6)
Subsequently the API Standards Associates documented the requests in email correspondence to the members of each applicable subcommittee.
Status of Work Groups
| WG |
Status |
| 5CT |
Will begin the ranking of questions |
| 5L |
Questions to be documented |
| 6A |
Will begin the ranking of questions |
| 7-1 |
Questions to be documented |
Volunteers are still being considered. Work Group activities will most likely be held in the Texas or Louisiana area; however, the specific location will be up to the WG chair person.
Bud Weightman
President / Managing Consultant
Qualified Specialists, International
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