BS ISO 18385:2016 pdf download – Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements
5.3 Authorization The responsibilities and authority for implementing, performing, and monitoring the procedures and requirements described in this International Standard shall be specified and documented.
5.4 Subcontracting of work and purchase of components The manufacturer shall evaluate and select suppliers and sub-contractors based on their ability to supply product in accordance with the manufacturers’ requirements that assist the manufacturer in meeting this International Standard. Criteria for selection, evaluation, and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained. The manufacturer shall retain responsibility for all components of their products.
5.5 Control of nonconforming product The manufacturer shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls for dealing with nonconforming product. Where applicable, the manufacturer shall deal with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release, or acceptance under concession by a relevant authority and, where applicable, by the customer;
c) by taking action to preclude its original intended use or application;
d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.
When nonconforming product is corrected, it shall be subject to re-verification to demonstrate conformity to the requirements. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained. Manufacturers shall establish procedures to notify customers who purchased released products subsequently found to have failed the product specifications or where the quality of the product has been impacted.
5.6 Corrective and preventive action Documented procedures shall be established to investigate quality issues identified through environmental monitoring (see Clause 7), batch release testing (see Clause 9), or customer complaints relating to product contamination. This shall include recording the following:
— nature and extent of the issue; — investigation to determine the root cause of the issue;
— corrective and preventive action taken; — review of the effectiveness of the corrective action.
5.7 Staff contamination detection provision Manufacturers shall document and implement a policy for the collection of relevant voluntary reference samples from personnel involved in the production of products.
NOTE 1 Refer to legislative or regulatory restrictions or preclusion in your jurisdiction regarding the collection of voluntary reference samples from staff. A voluntary reference sample should be collected, with written permission, from personnel who have the potential to introduce DNA into the product. Personnel included in the staff contamination detection system should be determined based on risk. If a sample is provided, a relevant DNA profile (see Annex C) shall be generated and recorded for quality assurance purposes. Information on the staff contamination detection system shall be documented.
NOTE 2 Humans are constantly shedding DNA and the inadvertent contamination of product is a constant and unavoidable risk regardless of control measures implemented. When staff contamination of a product occurs, it can lead them to being erroneously linked by police to a crime or a series of crimes. A staff contamination detection system is used to detect the occurrence of contamination and protect against an erroneous linkage.
6 Human DNA contamination risk management 6.1 General Risk management occurs across the product lifecycle. For the purposes of this International Standard, the scope of risk management is limited to risks that can introduce human DNA contamination into products used to collect, store, and analyze biological material for forensic purposes. The manufacturer shall establish, document, and maintain an on-going process for identifying, estimating, and evaluating the risks (see 6.2), controlling these risks (see 6.3 and 6.4), and monitoring the effectiveness of controls (see Clauses 7 and 9). The manufacturer shall collect and periodically review relevant product and process information (e.g. analysis of data, customer complaints, and corrective and preventive actions) to evaluate if any previously unrecognized risks are present or if a previously identified risk is no longer acceptable. If either of these occurs, the impact on previously implemented risk assessment and control measures shall be evaluated and the risk control measures updated as necessary. The results of the periodic reviews shall be recorded.BS ISO 18385 pdf download.