D. CUSTOMER RELATED PROCESSES & DOCUMENT CONTROL 雅詩(shī)蘭黛驗(yàn)廠之客戶相關(guān)流程和文件控制
1. Are customer approved specifications, drawings, standards and artwork incorporated into the facilities internal documentation?
顧客批準(zhǔn)認(rèn)可的規(guī)格,圖紙,標(biāo)準(zhǔn)和藝術(shù)品是否納入設(shè)施內(nèi)部文件?
2. Is there assurance that current editions are utilized in the manufacturing process (double checks)?
是否可以保證目前的版本使用于生產(chǎn)過(guò)程中(再次確認(rèn))
3. Are customers testing procedures being utilized properly?
是否適當(dāng)使用客戶的測(cè)試程序
4. Has the organization established and maintained a documented feedback system to provide early warning of potential and actual quality problems and to facilitate customer input into Corrective and preventative actions? (CAPA)
是否有建立和維持文件反饋系統(tǒng)提供潛在的和實(shí)際的質(zhì)量問(wèn)題,方便客戶輸入糾正和預(yù)防措施的預(yù)警組織?(CAPA)
5. When required by the customer, does the organization agree with the customer, which changes require written confirmation prior to approval and which changes require notification only?
當(dāng)顧客要求時(shí),組織是否同意客戶,這需要改變之前批準(zhǔn)的書(shū)面確認(rèn),哪些變化只需要通知?
6. Are proposed changes communicated in a timely manner and the process for introducing changes agreed?
所提議的改變是否及時(shí)的進(jìn)行溝通來(lái)介紹改變是否經(jīng)過(guò)同意的
7. Is there between the organization and the customer, a documented technical/QA agreement that includes the action to be taken for nonconformities?
是否有機(jī)構(gòu)和客戶之間的技術(shù)和質(zhì)量保證協(xié)議,文件,被視為不合格的行動(dòng)?
8. Are documented procedures for design and development implemented?
記錄設(shè)計(jì)和開(kāi)發(fā)實(shí)施的程序?
9. During the design and development process, is it ensured that outputs are verified as suitable before finalizing production specifications? (Cpk, fit / function, etc…)
在設(shè)計(jì)和開(kāi)發(fā)過(guò)程,是否保證輸出驗(yàn)證為適合在定型生產(chǎn)規(guī)格?(CPK,配合/功能,等..)
10. For new product launches, is there a system in place to develop testing procedures ensuring quality components?
新產(chǎn)品的推出,是否有系統(tǒng)開(kāi)發(fā)測(cè)試程序,確保質(zhì)量的成分?
11. Is there a system in place to investigate and assign corrective action to customer complaints and /or customer rejects?
是否有一個(gè)系統(tǒng)來(lái)調(diào)查和指定正確的行動(dòng)來(lái)解決客訴問(wèn)題和客戶退貨問(wèn)題
12. Is the customer notified prior to outsourcing any part of the production process?
把生產(chǎn)任何一部分外發(fā)之前是否通知客戶